of 23 /23
The University of British Columbia Office of Research Ethics Clinical Research Ethics Board – Room 210, 828 West 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce A. Vallance UBC/Medicine, Faculty of/Paediatrics H17-00303 SPONSORING AGENCIES: - BC Children's Hospital Research Institute - "UVB influences the human microbiota, a pilot study" - Natural Sciences and Engineering Research Council of Canada (NSERC) - "Vitamin D - A regulator of host-microbe interactions in the mammalian GI tract?" PROJECT TITLE: Intestinal Microbiota Changes after Ultraviolet Radiation B Exposure This letter will acknowledge receipt of the study closure. There are no items to display The following is a simplified summary of complex privacy and security requirements at UBC. For further information please consult: http://it.ubc.ca/services/security/ubc-information-security-office & http://universitycounsel.ubc.ca/access-and-privacy/ a. Make appropriate plans for archiving your project data to meet UBC policy requirements for study data to be retained for at least 5 years after presentation or publication within a UBC facility. b. Ensure plans for final data destruction comply with the minimum standards set out in Clearing and Declassifying Electronic Data Storage Devices (ITSG-06). c. Track and log disposal of all University-owned devices and electronic information. d. Be prepared to provide a data destruction certificate upon request to a data steward. Research Data Management UBC Library has implemented robust research data management software – Abacus Dataverse (http://dvn.library.ubc.ca/dvn/ )Dataverse is an open source repository designed to assist researchers in the creation, management and dissemination of their data. The Dataverse platform allows management of datasets, metadata, and digital objects and offers support for disposition of sensitive data, which has been collected under ethics approval. The system is opened to UBC researchers, labs and institutes. DMP Assistant (https://assistant.portagenetwork.ca/ software – is a bilingual tool for preparing data management plans (DMPs). The tool follows best practices in data stewardship and walks researchers step-by-step through key questions about data management including data storage, ethics and legislative requirements, data archiving, and future uses. Hosted by the national Portage (https://portagenetwork.ca/ initiative, DMP Assistant is designed to meet the anticipated Data Management Plan requirements (in English or French) of most major Canadian funders. DATE OF ACKNOWLEDGEMENT: February 12, 2019 Acknowledged on behalf of the Clinical Research Ethics Board by: Pia Ganz, Manager, Clinical Ethics

ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

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Page 1: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

The University of British ColumbiaOffice of Research EthicsClinical Research Ethics Board ndash Room 210 828 West 10th Avenue Vancouver BC V5Z 1L8

ACKNOWLEDGEMENT LETTER

PRINCIPAL INVESTIGATOR INSTITUTION DEPARTMENT UBC CREB NUMBERBruce A Vallance UBCMedicine Faculty

ofPaediatrics H17-00303

SPONSORING AGENCIES- BC Childrens Hospital Research Institute - UVB influences the human microbiota a pilot study- Natural Sciences and Engineering Research Council of Canada (NSERC) - Vitamin D - A regulator of host-microbe interactions in the mammalian GI tract PROJECT TITLEIntestinal Microbiota Changes after Ultraviolet Radiation B Exposure This letter will acknowledge receipt of the study closure

There are no items to display

The following is a simplified summary of complex privacy and security requirements at UBC For further information please consult httpitubccaservicessecurityubc-information-security-office amp httpuniversitycounselubccaaccess-and-privacy

a Make appropriate plans for archiving your project data to meet UBC policy requirements for study data to be retained for at least 5 years after presentation or publication within a UBC facility

b Ensure plans for final data destruction comply with the minimum standards set out in Clearing and Declassifying Electronic Data Storage Devices (ITSG-06)

c Track and log disposal of all University-owned devices and electronic information

d Be prepared to provide a data destruction certificate upon request to a data steward

Research Data Management

UBC Library has implemented robust research data management software ndash Abacus Dataverse (httpdvnlibraryubccadvn )Dataverse is an open source repository designed to assist researchers in the creation management and dissemination of their data The Dataverse platform allows management of datasets metadata and digital objects and offers support for disposition of sensitive data which has been collected under ethics approval The system is opened to UBC researchers labs and institutes

DMP Assistant (httpsassistantportagenetworkca software ndash is a bilingual tool for preparing data management plans (DMPs) The tool follows best practices in data stewardship and walks researchers step-by-step through key questions about data management including data storage ethics and legislative requirements data archiving and future uses Hosted by the national Portage (httpsportagenetworkca initiative DMP Assistant is designed to meet the anticipated Data Management Plan requirements (in English or French) of most major Canadian fundersDATE OF ACKNOWLEDGEMENT

February 12 2019

Acknowledged on behalf of the Clinical Research Ethics Board by

Pia Ganz Manager Clinical Ethics

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Date 5222019 30853 PM Print Close

The University of British Columbia Office of Research Services Clinical Research Ethics Board Room 210 828 West 10th Avenue Vancouver BC V5Z 1L8

H17-00303 UVB skin to gut study (Version 30)Principal Investigator Bruce A Vallance1 Principal Investigator amp Study Team - Human Ethics [View Form]

11 Principal Investigator Please select the PrincipalInvestigator (PI) for the studyOnce you hit Select you canenter the PIs name or enter thefirst few letters of his or hername and hit Go You can sortthe returned list alphabetically byFirst name Last name orOrganization by clicking theappropriate heading

LastName

FirstName EmployerName Email

Vallance Bruce A Paediatrics bvallancecwbcca

Enter Principal InvestigatorPrimary Department and also theprimary location of the PIsInstitution

Pediatics BCCHR

12 Primary Contact Providethe name of ONE primarycontact person in addition to thePI who will receive ALLcorrespondence certificates ofapproval and notifications fromthe REB for this study Thisprimary contact will have onlineaccess to read amend andtrack the application

Last Name First Name RankBosman Else Susan Graduate Student

13 Co-Investigators List all theCo-Investigators of the studyThese members WILL haveonline access which will allowthem to read amend and trackthe application These memberswill be listed on the certificate ofapproval (except BC CancerAgency Research Ethics Boardcertificates) If this researchapplication is for a graduatedegree enter the graduatestudents name in this section

LastName

FirstName InstitutionDepartment Rank

Lui Harvey UBCMedicine FacultyofDermatology amp Skin Science Professor

Bosman ElseSusan

UBCMedicine FacultyofPaediatrics

GraduateStudent

Dutz Jan P UBCMedicine FacultyofDermatology amp Skin Science Professor

Role in Study Describe each co-

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Is role in study eg statisticiansupervisor adviser student etc14 Additional Study TeamMembers - Online Access Listthe additional study teammembers who WILL have onlineaccess to read amend andtrack the application but WILLNOT be listed on the certificateof approval

Last Name First Name InstitutionDepartment Rank

Role in Study

15 Additional Study TeamMembers - No Online Access Click Add to list study teammembers who WILL NOT haveonline access to the applicationand will NOT be listed on thecertificate of approval

LastName

FirstName

Institution Department

Rank JobTitle

Email Address

Stintzi AlainFaculty ofMedicineUniversity ofOttawa

Vice-Dean astintziuottawaca

Role in Study Tri Council Policy Statement2(TCPS2) Tutorial All study teammembers (including but notlimited to faculty undergraduateand graduate students medicalresidents and research staff) arerequired to complete the TCPS2Tutorial (CORE) beforesubmission Indicate completionof the TCPS2 (CORE) tutorialbelow 16A All Facultyincluding hospital appointmentequivalents deemed a PI by anaffiliated institution or by a Dean

Yes

16B All Other Study Teammembers Yes

Comments 17 Project Title Enter the titleof this research study as it willappear on the certificate Ifapplicable include the protocolnumber in brackets at the end ofthe title If this is a class-basedproject see guidance on theright Title given must match thetitle on all study documents

Intestinal Microbiota Changes after Ultraviolet Radiation BExposure

18 Project Nickname Enter anickname for this study Whatwould you like this study to be

UVB skin to gut study

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known as to the PrincipalInvestigator and study team2 Study Dates and Funding - Human Ethics [View Form]

You plan to start collecting dataimmediately after obtainingethics and any other requiredapprovals (the start date on theethics certificate will reflect theapproval date)

yes

You plan to start data collectionat a later date ie 2 months ormore after approvals areobtained Click the calendar iconbelow to select the dates(Internet Explorer) or enter thedates manually using the formatyyyy-mm-dd Estimated startdate

21 B Estimated end date 8312018 22A Types of Funds Pleaseselect the applicable box(es)below to indicate the type(s) offunding you are receiving toconduct this research You mustthen complete section 23 andorsection 24 for the name of thesource of the funds to be listedon the certificate of approval

Grant

22B For Industry Sponsoredstudies please provide asponsor contact

22C Please enter anyapplicable information aboutyour funding which is not alreadyshown in Box 23 or 24(including funding applied for butnot yet received)

23 Research FundingApplicationAward Associatedwith the Study that wasSubmitted to the UBC Office ofResearch Services Please clickAdd to identify the researchfunding applicationawardassociated with this studySelecting Add will list thesources of all research fundingapplications that have beensubmitted by the PI (and theperson completing thisapplication if different from the

UBCNumber Title Sponsor

F12-04845

Vitamin D - A regulator ofhost-microbe interactionsin the mammalian GItract

Natural Sciences andEngineering ResearchCouncil of Canada(NSERC)

F17-05461

UVB influences thehuman microbiota a pilotstudy

BC Childrens HospitalResearch Institute

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PI) If the research fundingapplicationaward associatedwith this study is not listed belowplease enter those details inquestion 2424 Research FundingApplicationAward Associatedwith the Study not listed inquestion 23 Please click Addto enter the details for theresearch fundingapplicationaward associatedwith this study that is not listed inquestion 23 When you pressAdd you can do a search foryour funding award by doing asearch in the Sponsor box - over7000 options are listed

UBC Number Title Sponsor

25A Is this a DHHS grant (Toview a list of DHHS fundingagencies click on add in 25Bbelow)

no

25B If yes please select theappropriate DHHS fundingagency from the selection boxand attach the grant to box 98of the application

DHHS Sponsor List Order Active

Attach DHHS Grant Applicationfor each sponsor listed above

26 Conflict of Interest Conflictsof Interest (COIs) can arisenaturally from an Investigatorrsquosengagement inside and outsidethe University and the mereexistence of a COI or theperception of a COI does notnecessarily imply wrongdoing onanyonersquos part Nonetheless realand perceived COI must berecognized disclosed andassessed This question asksInvestigators to disclose COIsthat may relate to the researchstudy that is the subject of theREB application Do thePrincipal Investigator Co-Investigators andor their relatedparties (defined at s812 UBCPolicy 97) have any personalinterest(s) that couldcompromise or reasonably beperceived to compromise the

no

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objective conduct of the researchor the integrity of the datagenerated by the studyPersonal interests may includebusiness commercial orfinancial interests as well aspersonal matters and careerinterests4 Study Type - Human Ethics Application [View Form]

41 UBC Research Ethics Board Indicate which UBC ResearchEthics Board you are applying toand the type of study you areapplying for

UBC Clinical Research Ethics Board

NA no

42A Institutions and Sites forStudy

Institution SiteVancouver Coastal Health(VCHRIVCHA)

Vancouver GeneralHospital

Childrens and Womens HealthCentre of BC (incl Sunny Hill)

BC Childrens Hospital(includes ResearchInstitute)

42B Please enter any otherlocations where the research willbe conducted under thisResearch Ethics Approval (egName of privately owned cliniccommunity centre schoolclassroom participants home inthe field - provide details)

The data will be collected in The Skin Care Center locatedat Vancouver General Hospital and data analysis will bedone by Life Labs and by the University of Ottawa incollaboration with professor Stintzi Data storage will bedone in the BCCHR institute

4 Clinical Study Review Type [View Form]

43 Relationship with otherproposals 43A If this proposalis closely linked to any otherproposalpreviouslysimultaneouslysubmitted enter the ResearchEthics Board number of thatproposal

No

43B If applicable pleasedescribe the relationshipbetween this proposal and thepreviouslysimultaneouslysubmitted proposal listed above

43C Have you received anyinformation or are you aware ofany rejection of this study by anyResearch Ethics Board If yesplease provide known details

no

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and attach any available relevantdocumentation in question 9743D Will biological materialsbe collected or analyzed by UBCresearchers or a UBC researchlab If yes please provide theUBC Biosafety Permit Number

No

43E Will radioisotopes beused in this project If yesprovide the UBC RadiationPermit Number

NA

44 Level of Risk Afterreviewing the minimal riskguidance notes and the criteriafor minimal risk does this studyqualify for minimal risk reviewNote that all studies which do notfall into the minimal risk categorywill undergo full board review

no

Peer Review If this researchproposal has received anyindependentscientificmethodological peerreview please include thenames of committees orindividuals involved in thereview State whether the peerreview process is ongoing orcompleted All above minimalrisk studies generally require apeer review 45A Externalpeer review details

NO

45B Internal (UBC or hospital)peer review details Yes dr Vincent Ho MD FRCPC FRCP completed

45C If this research proposalhas NOT received anyindependentscientificmethodological peerreview explain why no reviewhas taken place

NA

46 Multi-jurisdictional studies Please read and review theguidance note on the right priorto completing this question Isthis study a multi-jurisdictionalstudy that will also require reviewby one or more REB with whichthe University of BritishColumbia has a collaborativereview agreement (See theguidance to the right for detailsabout the harmonized process)

no

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Simon Fraser University University of Alberta Universityof Northern British Columbia Northern Health Authority University of Saskatchewan University of Victoria IslandHealth Authority Fraser HealthAuthority Interior HealthAuthority Note If submitting anamendment for an alreadyapproved study you mustrespond ldquoNordquo to this question)4 Clinical Study Review Type (Q 47 48) [View Form]

47A Creation of a Registry(Data or Tissue Bank) Doesthis study involve the creation ofa registry (data or tissue bank)for future use in other research[if no skip to 48]

no

47B Is the purpose of thisapplication exclusively to obtainapproval for the creation of aresearch database registry ortissue bank [Note if the creationof the database or registry ortissue repository is part of abigger project also included inthis application you mustanswer no below]

no

Clinical Chart Review 48A Isthis an application for researchrequiring access to clinical chartsOR data from registries ordatabases such as PopData BCor Pharmanet

no

48B Insert the date range ofthe chartsdata to be included inthis research (eg 7 September2005 ndash 6 September 2011)

48C Is this study exclusively aretrospective chart review wherethe only source of data will bemedical chartsrecords that arecurrently in existence (ie willpre-date the date of your initialethics approval)

48D Are you collecting andretaining personally identifiableinformation to be a part of thedata set

48E Is this a retrospective

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chart review study for whichparticipant consent will beobtained5 Summary of Study and Recruitment - Clinical Study [View Form]

51 Study Summary 51A Provide a short summary of theproject written in lay languagesuitable for non-scientific REBmembers DO NOT exceed 100words and do not cut and pastedirectly from the study protocol

This research will explore the potential effects of Narrow-Band Ultra Violet B (NB-UVB) radiation on the intestinalmicrobiota composition and confirm a regulatory skin-to-gutaxis during baseline conditions Changes in the intestinalmicrobiota composition caused by NB-UVB phototherapycould be beneficial for patients with chronicauto-inflammatory diseases like IBD by removing dangerousbacteria increasing beneficial bacteria and ultimatelymodulating immune responses

51B Summarize the researchproposal Purpose Hypothesis Justification ObjectivesResearch Design and StatisticalAnalysis

Purpose To explore the potential effects of Narrow-Band Ultra VioletB (NB-UVB) radiation on the intestinal microbiotacomposition in humans and confirm a regulatory skin-to-gutaxis during baseline conditions Hypothesis Humans exposed to UVB-NB light will show changes in theintestinal microbiota composition with selection of certainphyla of bacteria Justification To date there is no data that describes a biologicalresponse to UVB light in the body that affects the intestinalmicrobiota Changes in the intestinal microbiotacomposition caused by NB-UVB phototherapy could bebeneficial for patients with chronicauto-inflammatorydiseases like IBD by removing dangerous bacteriaincreasing beneficial bacteria and ultimately modulatingimmune responses Objectives 1 Establish if there is an skin regulatory response towardsNB-UVB light in humans 2 Examine what changes in the microbiota compositioncan be observed on bacterial phyla and class level 3 Determine if this research is worth pursuing in a largercohort Research design During the first visit the skin type will be assessed by usingthe Fitzpatrick skin type questionnaire Subsequently subjects will be exposed three times withinone week to full body NB-UVB light in The Skin CareCentre to a sub erythemic dose (cause slight redness of theskin but not burning) The exposures will happen during thewinter months to prevent UVB exposure from the sunduring daily activities to interfere with our observationsStool samples will be collected before the first exposure(2x) and after the last exposure (2x) to analyse the

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microbiota composition Also serum vitamin D (25-hydroxyvitamin D) will be measured before and after the UVBexposure as a marker of previous UVB exposure before theexperiment Subjects will be healthy Caucasian females between 19-40years of age with a Fitzpatrick skin type I II or III tominimise the variability in skin responses towards the UVB-NB light since fair skin colour is less adapted to absorb theUVB radiation than dark coloured skin The microbiota composition will be analysed with 16S rRNAIllumina sequencing and calculated for differentialabundance on phylum level Statistical analysis The statistical analysis will focus the personal microbiotacomposition variation after NB-UVB light exposure incomparison to before the UVB light exposure Because wecollect two samples before and two samples after the UVBexposures each individual can serve as her own internalcontrol

52 Inclusion Criteria InclusionCriteria Describe theparticipants being selected forthis study and list the criteria fortheir inclusion For researchinvolving human pluripotent stemcells provide a detaileddescription of the stem cellsbeing used in the research

Healthy Caucasian females between 19-40 years of age Fitzpatrick skin type I II or III (see box 98A for Fitzpatrickskin type assessment)

53 Exclusion Criteria Exclusion Criteria Describewhich potential participants willbe excluded from participationand list the criteria for theirexclusion

The participants will be excluded if they have skin photosensitivity or taking medication that promotes photosensitivity of their skin Also participants that have been onvacation to a sunny destination since October 2017 or visittanning beds on a regular basis will be excluded becausethey have been exposed to UVB radiation

54 Recruitment Provide adetailed description of themethod of recruitment Includewhere applicable A) Who willcontact prospective participantsB) by what means this will bedone C) How prospectiveparticipants will be identified D)Ensure that any letters of initialcontact or other recruitmentmaterials are attached to thissubmission on Page 9

The recruitment will be done via social media withFacebook (UVBstudy page) The recruitment advertisementis included in the submission The researcher will contactprospective participants after they voluntarily contacted thestudy email address UVBstudyalumniubcca Initial contact will be through email conversation until thepotential participant expresses interest participating byemail Once the participant has signed the consent form astudy identifier will be assigned to the participant to protectthe individuals identity

55 Recruitment ofNormalControl Participants Describe how prospectivenormalcontrol participants will

Each participant will serve as her own control Allparticipants will be recruited the same way

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be identified contacted andrecruited if the method differsfrom the above56 Use of Records If existingrecords (eg health recordsclinical lists or otherrecordsdatabases) will be usedto IDENTIFY potentialparticipants or COLLECT DATAplease describe how permissionto access this information and tocollect and use this informationwill be obtained

No existing records will be used for this study

57 Summary of StudyProcedures

Participants will contact the study coordinator and will beinvited to participate by and email that will be sent alongwith the consent form A first meeting will be set upbetween the research coordinator and the participant at theSkin Care Center to explain the protocol and to signconsent forms Also four stool collection kits will be handedto the participant After signing the consent form theFitzpatrick skin type will be assessed with the hand of aquestionnaire about the sun exposure habits The participant is responsible to collect two stool samplesduring the week prior to the first light exposure and store itin her freezer at home On the Monday of the first NB-UVB exposure the researchcoordinator will confirm that a stool sample is collected bythe participant The participant will be referred to the lab atLife Labs to collect one blood sample (one tube of 15 mlapproximately one table spoon full) and will later go to TheSkin Care Centre at VGH where the participants will beassessed under supervision of dr Harvey Lui MD for theirfirst full body NB-UVB exposure The participants will wearspecialised goggles to protect the eyes from the UVB raysand wear broad spectrum sunscreen on face and hands toprotect these areas from the light The NB-UVB lightexposure will happen in a full body cabin like an uprighttanning bed and will take no longer than 5 minutes A timewill be scheduled for the next two sessions with theparticipants On Wednesday and Friday the participant willreceive a NB-UVB dose that is 10 higher than the fisrtvisit if tolerated well Description of blood collection procedure at Life Labs Ablood sample will be taken by first applying a tourniquet tothe upper arm The skin on the inner side of the elbow willbe sterilised and a small sterile needle will be inserted intothe vein Two blood collection tubes will then be attached tothe needle which will fill with blood When the tube is fullthe needle will be removed A plaster or small bandage will be applied to cover the site where the needle

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was removed Blood samples will be marked with their study identifiersand analysed in Life labs for of serum 25-hydroxy vitaminD3 according to Standards Council of Canadarsquos GoodLaboratory Practice (GLP) principles and Good ClinicalPractice (GCP) The participant is responsible to collect tw stool samplesthe week after the three NB-UVB light exposures and storeit in the freezer The research coordinator will contact theparticipant when and where to pick up the stool samples orparticipant can drop them off at their own convenience atthe Skin Care Centre during on Monday Wednesday andFriday nights The stool samples that are collected from the participantwill be stored in the BCCHR in a -80C freezer in a lockedlab until all samples from all participants are collectedOnce all stool samples are collected they will be send offto the Stintzi Lab at the University of Ottawa for 16S rRNAsequencing The results will be analysed and stored on theBCCHR password-secured computer

6 Participant Information and Consent Process - Clinical Study [View Form]

61 Time to Participate Howmuch time will a participant beasked to dedicate to the projectbeyond that needed for normalcare

The first visit to sign the consent form and do the Skin typeassessment will take approximately 20 minutes The visitfor the first UVB exposure will take approx 20 minutes toreview the exposure methods The next two visits will take approximately 10-12 minuteseach The visits for the blood draws will take about 30 minutesdepending on the amount of waiting time of the Life Labslocation The total time the participant will spend to this study will be2 hours minutes

62 Time to Participate ndashNormalControl Participants Ifapplicable how much time will anormalcontrol volunteer beasked to dedicate to the project

Each participant will be treated similarly

63 RisksHarms Describe whatis known about the risks(harms) of the proposedresearch

The exposure to NB-UVB light will turn the skin slightly pinkfor 1-2 days NB-UVB is ultraviolet radiation and couldcause long term effects after excessive exposure like skinageing and skin cancer The exposure from this study isequivalent to 5 min sun exposure during a summerrsquos dayper visit and is unlikely to have any long-term effects Short-term side effects may include skin redness skin drynesstriggering of a cold sore All of these effects are minor and

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will resolve usually within a week In rare cases the skinmight turn red and gives a sun burn-like sensation In thiscase the sensation will fade away over the next days Theparticipant should contact the researcher in this case Although minimal there is a 05 risk of bleeding from theneedle site If this occurs the subject can be given apressure bandage The risks of blood draw also includespain andor discomfort bruising fainting andor lightheaded sensation and the rare possibility of infection

64 Benefits Describe anypotential benefits to theparticipant that could arise fromhis or her participation in theproposed research

Exposure to NB-UVB will produce vitamin D in your skinthat helps against seasonal affective disorder (SAD) and isimportant for your general health

65 Reimbursement Describeany reimbursement for expenses(eg meals parkingmedications) orpaymentsincentivesgifts-in-kind(eg honoraria gifts prizescredits) to be offered to theparticipants Provide full detailsof the amounts paymentschedules and value of gifts-in-kind

There is a $750 budget for this study for the 30 testparticipants Each participant will be given a $25 gift-certificate when the stool samples are collected and theparticipant is done with the study requirements

66 Obtaining Consent SpecifyA) who will explain the consentform B) who will consentparticipants C) Include details ofwhere the consent will beobtained and under whatcircumstances and D) therelationship of the personobtaining consent andparticipant

Once the potential participants agree to participate to thestudy by email the consent form will be explained in personby the research coordinator The research coordinator willbe able to answer all questions about possible concernsand about the procedure The consent form will bediscussed in person with the participant in an office settingin the Skin Care Center Once the participants sign theconsent form they agree to be a part of the study Theparticipants will get the stool collection kits at that time andwill come back for the further procedures one week laterThe participant is free to withdraw from the study at anygiven time for the duration of the study The physicians at the Skin Care Centre will go through theprocedures with the participant and is able to answer anyquestions regarding the UVB exposure

67A WaiverAlteration ofConsent If you are asking for awaiver or an alteration of therequirement for participantinformed consent please justifythe waiver or alteration andexplain how the study meets allthe criteria on the right Pleaseclick Guidance Notes on rightand ensure that you address

There will be no waiver

5222019 No Title

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each criteria individually Includethe corresponding letter (A B CD E) before each answer67B Waiver of Consent inIndividual Medical EmergenciesIf you are asking for a waiver oran alteration of the requirementfor participant informed consentin individual medicalemergencies please justify thewaiver or alteration and explainhow the study meets all thecriteria on the right Please clickGuidance Notes on right andensure that you address eachcriteria individually Include thecorresponding letter (A B C DE) before each answer

NA

68 Time to Consent How longafter being provided with detailedinformationconsent form aboutthe study will the participanthave to decide whether or not toparticipate Provide yourrationale for the amount of timegiven

Once the participant contacts the study by email theconsent form will be sent to them by email to read throughbefore the first meeting The research coordinator willdiscuss the contents of the consent form with theparticipant one week prior to the UVB light exposureprotocol Thus participants will have 1-2 weeks to reviewthe consent form before making a decision aboutparticipation

69 Capacity to Consent Willevery participant have thecapacity to give fully informedconsent on hisher own behalfPlease click Select to completethe question and view furtherdetails

Will theparticipanthave thecapacityto givefullyinformedconsent

Details ofthe natureof theincapacity

If notwhowillconsentonhisherbehalf

If not willheshe beable to giveassent toparticipate

If Yesexplainhowassentwill besought

Yes [Details]

610 Renewal of ConsentDescribe any situation in whichthe renewal of consent for thisresearch might be appropriateand how this would take place

There are no plans for renewal of consent No furthercontact is required after obtaining the samples All samplesand data will be de-identified on collection and cannot betracked back to the subjects

611 Provisions for ConsentWhat provisions are planned forparticipants or those consentingon a participants behalf to havespecial assistance if neededduring the consent process (egconsent forms in Braille or inlanguages other than English)

Participants have to be able bodied to be able to participatein order to receive the UVB exposure Subjects with nounderstanding of the English language will not beapproached for involvement in the study unless a translatoris present who can converse in the first language of thesubject

612 Restrictions on DisclosureDescribe any restrictions

There are no restrictions on disclosure of information

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regarding the disclosure ofinformation to researchparticipants (during or at the endof the study) that the sponsorhas placed on investigatorsincluding those related to thepublication of results Alsoindicate any plans forcommunicating study results toparticipants7 Number of Participants and Study Drugs - Clinical Study [View Form]

71 Multi-Centre Studies 71A Is this a multi-centre study(involves centres outside ofthose applied for under thisApproval)

no

If known please list the othersites below

71B Is this study beingsubmitted for ethical approval toany other Research EthicsBoard

DescriptionNo

If yes please provide the nameof the REB(s) and if availablecontact information

72 Number of Participants 72A How many participants(including controls) will beenrolled in the entire study (iethe entire study world-wide)

30

72B How many participants(including controls) will beenrolled at institutions coveredby this Research EthicsApproval (ie only at theinstitutions covered by thisapproval)

30

72C Of these how many arecontrols 0

72D Please enter anyadditional comments

73 Drug approvals Enter thegeneric name of anyinvestigational drug(s) not yetapproved or any marketeddrug(s) used outside of itsapproved indication

NA

74 Marketed Drugs Enter thename of any marketed drug(s)

NA

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used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

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amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

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ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

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files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

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Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

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on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

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will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

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112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 2: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

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Date 5222019 30853 PM Print Close

The University of British Columbia Office of Research Services Clinical Research Ethics Board Room 210 828 West 10th Avenue Vancouver BC V5Z 1L8

H17-00303 UVB skin to gut study (Version 30)Principal Investigator Bruce A Vallance1 Principal Investigator amp Study Team - Human Ethics [View Form]

11 Principal Investigator Please select the PrincipalInvestigator (PI) for the studyOnce you hit Select you canenter the PIs name or enter thefirst few letters of his or hername and hit Go You can sortthe returned list alphabetically byFirst name Last name orOrganization by clicking theappropriate heading

LastName

FirstName EmployerName Email

Vallance Bruce A Paediatrics bvallancecwbcca

Enter Principal InvestigatorPrimary Department and also theprimary location of the PIsInstitution

Pediatics BCCHR

12 Primary Contact Providethe name of ONE primarycontact person in addition to thePI who will receive ALLcorrespondence certificates ofapproval and notifications fromthe REB for this study Thisprimary contact will have onlineaccess to read amend andtrack the application

Last Name First Name RankBosman Else Susan Graduate Student

13 Co-Investigators List all theCo-Investigators of the studyThese members WILL haveonline access which will allowthem to read amend and trackthe application These memberswill be listed on the certificate ofapproval (except BC CancerAgency Research Ethics Boardcertificates) If this researchapplication is for a graduatedegree enter the graduatestudents name in this section

LastName

FirstName InstitutionDepartment Rank

Lui Harvey UBCMedicine FacultyofDermatology amp Skin Science Professor

Bosman ElseSusan

UBCMedicine FacultyofPaediatrics

GraduateStudent

Dutz Jan P UBCMedicine FacultyofDermatology amp Skin Science Professor

Role in Study Describe each co-

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Is role in study eg statisticiansupervisor adviser student etc14 Additional Study TeamMembers - Online Access Listthe additional study teammembers who WILL have onlineaccess to read amend andtrack the application but WILLNOT be listed on the certificateof approval

Last Name First Name InstitutionDepartment Rank

Role in Study

15 Additional Study TeamMembers - No Online Access Click Add to list study teammembers who WILL NOT haveonline access to the applicationand will NOT be listed on thecertificate of approval

LastName

FirstName

Institution Department

Rank JobTitle

Email Address

Stintzi AlainFaculty ofMedicineUniversity ofOttawa

Vice-Dean astintziuottawaca

Role in Study Tri Council Policy Statement2(TCPS2) Tutorial All study teammembers (including but notlimited to faculty undergraduateand graduate students medicalresidents and research staff) arerequired to complete the TCPS2Tutorial (CORE) beforesubmission Indicate completionof the TCPS2 (CORE) tutorialbelow 16A All Facultyincluding hospital appointmentequivalents deemed a PI by anaffiliated institution or by a Dean

Yes

16B All Other Study Teammembers Yes

Comments 17 Project Title Enter the titleof this research study as it willappear on the certificate Ifapplicable include the protocolnumber in brackets at the end ofthe title If this is a class-basedproject see guidance on theright Title given must match thetitle on all study documents

Intestinal Microbiota Changes after Ultraviolet Radiation BExposure

18 Project Nickname Enter anickname for this study Whatwould you like this study to be

UVB skin to gut study

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known as to the PrincipalInvestigator and study team2 Study Dates and Funding - Human Ethics [View Form]

You plan to start collecting dataimmediately after obtainingethics and any other requiredapprovals (the start date on theethics certificate will reflect theapproval date)

yes

You plan to start data collectionat a later date ie 2 months ormore after approvals areobtained Click the calendar iconbelow to select the dates(Internet Explorer) or enter thedates manually using the formatyyyy-mm-dd Estimated startdate

21 B Estimated end date 8312018 22A Types of Funds Pleaseselect the applicable box(es)below to indicate the type(s) offunding you are receiving toconduct this research You mustthen complete section 23 andorsection 24 for the name of thesource of the funds to be listedon the certificate of approval

Grant

22B For Industry Sponsoredstudies please provide asponsor contact

22C Please enter anyapplicable information aboutyour funding which is not alreadyshown in Box 23 or 24(including funding applied for butnot yet received)

23 Research FundingApplicationAward Associatedwith the Study that wasSubmitted to the UBC Office ofResearch Services Please clickAdd to identify the researchfunding applicationawardassociated with this studySelecting Add will list thesources of all research fundingapplications that have beensubmitted by the PI (and theperson completing thisapplication if different from the

UBCNumber Title Sponsor

F12-04845

Vitamin D - A regulator ofhost-microbe interactionsin the mammalian GItract

Natural Sciences andEngineering ResearchCouncil of Canada(NSERC)

F17-05461

UVB influences thehuman microbiota a pilotstudy

BC Childrens HospitalResearch Institute

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PI) If the research fundingapplicationaward associatedwith this study is not listed belowplease enter those details inquestion 2424 Research FundingApplicationAward Associatedwith the Study not listed inquestion 23 Please click Addto enter the details for theresearch fundingapplicationaward associatedwith this study that is not listed inquestion 23 When you pressAdd you can do a search foryour funding award by doing asearch in the Sponsor box - over7000 options are listed

UBC Number Title Sponsor

25A Is this a DHHS grant (Toview a list of DHHS fundingagencies click on add in 25Bbelow)

no

25B If yes please select theappropriate DHHS fundingagency from the selection boxand attach the grant to box 98of the application

DHHS Sponsor List Order Active

Attach DHHS Grant Applicationfor each sponsor listed above

26 Conflict of Interest Conflictsof Interest (COIs) can arisenaturally from an Investigatorrsquosengagement inside and outsidethe University and the mereexistence of a COI or theperception of a COI does notnecessarily imply wrongdoing onanyonersquos part Nonetheless realand perceived COI must berecognized disclosed andassessed This question asksInvestigators to disclose COIsthat may relate to the researchstudy that is the subject of theREB application Do thePrincipal Investigator Co-Investigators andor their relatedparties (defined at s812 UBCPolicy 97) have any personalinterest(s) that couldcompromise or reasonably beperceived to compromise the

no

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objective conduct of the researchor the integrity of the datagenerated by the studyPersonal interests may includebusiness commercial orfinancial interests as well aspersonal matters and careerinterests4 Study Type - Human Ethics Application [View Form]

41 UBC Research Ethics Board Indicate which UBC ResearchEthics Board you are applying toand the type of study you areapplying for

UBC Clinical Research Ethics Board

NA no

42A Institutions and Sites forStudy

Institution SiteVancouver Coastal Health(VCHRIVCHA)

Vancouver GeneralHospital

Childrens and Womens HealthCentre of BC (incl Sunny Hill)

BC Childrens Hospital(includes ResearchInstitute)

42B Please enter any otherlocations where the research willbe conducted under thisResearch Ethics Approval (egName of privately owned cliniccommunity centre schoolclassroom participants home inthe field - provide details)

The data will be collected in The Skin Care Center locatedat Vancouver General Hospital and data analysis will bedone by Life Labs and by the University of Ottawa incollaboration with professor Stintzi Data storage will bedone in the BCCHR institute

4 Clinical Study Review Type [View Form]

43 Relationship with otherproposals 43A If this proposalis closely linked to any otherproposalpreviouslysimultaneouslysubmitted enter the ResearchEthics Board number of thatproposal

No

43B If applicable pleasedescribe the relationshipbetween this proposal and thepreviouslysimultaneouslysubmitted proposal listed above

43C Have you received anyinformation or are you aware ofany rejection of this study by anyResearch Ethics Board If yesplease provide known details

no

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and attach any available relevantdocumentation in question 9743D Will biological materialsbe collected or analyzed by UBCresearchers or a UBC researchlab If yes please provide theUBC Biosafety Permit Number

No

43E Will radioisotopes beused in this project If yesprovide the UBC RadiationPermit Number

NA

44 Level of Risk Afterreviewing the minimal riskguidance notes and the criteriafor minimal risk does this studyqualify for minimal risk reviewNote that all studies which do notfall into the minimal risk categorywill undergo full board review

no

Peer Review If this researchproposal has received anyindependentscientificmethodological peerreview please include thenames of committees orindividuals involved in thereview State whether the peerreview process is ongoing orcompleted All above minimalrisk studies generally require apeer review 45A Externalpeer review details

NO

45B Internal (UBC or hospital)peer review details Yes dr Vincent Ho MD FRCPC FRCP completed

45C If this research proposalhas NOT received anyindependentscientificmethodological peerreview explain why no reviewhas taken place

NA

46 Multi-jurisdictional studies Please read and review theguidance note on the right priorto completing this question Isthis study a multi-jurisdictionalstudy that will also require reviewby one or more REB with whichthe University of BritishColumbia has a collaborativereview agreement (See theguidance to the right for detailsabout the harmonized process)

no

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Simon Fraser University University of Alberta Universityof Northern British Columbia Northern Health Authority University of Saskatchewan University of Victoria IslandHealth Authority Fraser HealthAuthority Interior HealthAuthority Note If submitting anamendment for an alreadyapproved study you mustrespond ldquoNordquo to this question)4 Clinical Study Review Type (Q 47 48) [View Form]

47A Creation of a Registry(Data or Tissue Bank) Doesthis study involve the creation ofa registry (data or tissue bank)for future use in other research[if no skip to 48]

no

47B Is the purpose of thisapplication exclusively to obtainapproval for the creation of aresearch database registry ortissue bank [Note if the creationof the database or registry ortissue repository is part of abigger project also included inthis application you mustanswer no below]

no

Clinical Chart Review 48A Isthis an application for researchrequiring access to clinical chartsOR data from registries ordatabases such as PopData BCor Pharmanet

no

48B Insert the date range ofthe chartsdata to be included inthis research (eg 7 September2005 ndash 6 September 2011)

48C Is this study exclusively aretrospective chart review wherethe only source of data will bemedical chartsrecords that arecurrently in existence (ie willpre-date the date of your initialethics approval)

48D Are you collecting andretaining personally identifiableinformation to be a part of thedata set

48E Is this a retrospective

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chart review study for whichparticipant consent will beobtained5 Summary of Study and Recruitment - Clinical Study [View Form]

51 Study Summary 51A Provide a short summary of theproject written in lay languagesuitable for non-scientific REBmembers DO NOT exceed 100words and do not cut and pastedirectly from the study protocol

This research will explore the potential effects of Narrow-Band Ultra Violet B (NB-UVB) radiation on the intestinalmicrobiota composition and confirm a regulatory skin-to-gutaxis during baseline conditions Changes in the intestinalmicrobiota composition caused by NB-UVB phototherapycould be beneficial for patients with chronicauto-inflammatory diseases like IBD by removing dangerousbacteria increasing beneficial bacteria and ultimatelymodulating immune responses

51B Summarize the researchproposal Purpose Hypothesis Justification ObjectivesResearch Design and StatisticalAnalysis

Purpose To explore the potential effects of Narrow-Band Ultra VioletB (NB-UVB) radiation on the intestinal microbiotacomposition in humans and confirm a regulatory skin-to-gutaxis during baseline conditions Hypothesis Humans exposed to UVB-NB light will show changes in theintestinal microbiota composition with selection of certainphyla of bacteria Justification To date there is no data that describes a biologicalresponse to UVB light in the body that affects the intestinalmicrobiota Changes in the intestinal microbiotacomposition caused by NB-UVB phototherapy could bebeneficial for patients with chronicauto-inflammatorydiseases like IBD by removing dangerous bacteriaincreasing beneficial bacteria and ultimately modulatingimmune responses Objectives 1 Establish if there is an skin regulatory response towardsNB-UVB light in humans 2 Examine what changes in the microbiota compositioncan be observed on bacterial phyla and class level 3 Determine if this research is worth pursuing in a largercohort Research design During the first visit the skin type will be assessed by usingthe Fitzpatrick skin type questionnaire Subsequently subjects will be exposed three times withinone week to full body NB-UVB light in The Skin CareCentre to a sub erythemic dose (cause slight redness of theskin but not burning) The exposures will happen during thewinter months to prevent UVB exposure from the sunduring daily activities to interfere with our observationsStool samples will be collected before the first exposure(2x) and after the last exposure (2x) to analyse the

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microbiota composition Also serum vitamin D (25-hydroxyvitamin D) will be measured before and after the UVBexposure as a marker of previous UVB exposure before theexperiment Subjects will be healthy Caucasian females between 19-40years of age with a Fitzpatrick skin type I II or III tominimise the variability in skin responses towards the UVB-NB light since fair skin colour is less adapted to absorb theUVB radiation than dark coloured skin The microbiota composition will be analysed with 16S rRNAIllumina sequencing and calculated for differentialabundance on phylum level Statistical analysis The statistical analysis will focus the personal microbiotacomposition variation after NB-UVB light exposure incomparison to before the UVB light exposure Because wecollect two samples before and two samples after the UVBexposures each individual can serve as her own internalcontrol

52 Inclusion Criteria InclusionCriteria Describe theparticipants being selected forthis study and list the criteria fortheir inclusion For researchinvolving human pluripotent stemcells provide a detaileddescription of the stem cellsbeing used in the research

Healthy Caucasian females between 19-40 years of age Fitzpatrick skin type I II or III (see box 98A for Fitzpatrickskin type assessment)

53 Exclusion Criteria Exclusion Criteria Describewhich potential participants willbe excluded from participationand list the criteria for theirexclusion

The participants will be excluded if they have skin photosensitivity or taking medication that promotes photosensitivity of their skin Also participants that have been onvacation to a sunny destination since October 2017 or visittanning beds on a regular basis will be excluded becausethey have been exposed to UVB radiation

54 Recruitment Provide adetailed description of themethod of recruitment Includewhere applicable A) Who willcontact prospective participantsB) by what means this will bedone C) How prospectiveparticipants will be identified D)Ensure that any letters of initialcontact or other recruitmentmaterials are attached to thissubmission on Page 9

The recruitment will be done via social media withFacebook (UVBstudy page) The recruitment advertisementis included in the submission The researcher will contactprospective participants after they voluntarily contacted thestudy email address UVBstudyalumniubcca Initial contact will be through email conversation until thepotential participant expresses interest participating byemail Once the participant has signed the consent form astudy identifier will be assigned to the participant to protectthe individuals identity

55 Recruitment ofNormalControl Participants Describe how prospectivenormalcontrol participants will

Each participant will serve as her own control Allparticipants will be recruited the same way

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be identified contacted andrecruited if the method differsfrom the above56 Use of Records If existingrecords (eg health recordsclinical lists or otherrecordsdatabases) will be usedto IDENTIFY potentialparticipants or COLLECT DATAplease describe how permissionto access this information and tocollect and use this informationwill be obtained

No existing records will be used for this study

57 Summary of StudyProcedures

Participants will contact the study coordinator and will beinvited to participate by and email that will be sent alongwith the consent form A first meeting will be set upbetween the research coordinator and the participant at theSkin Care Center to explain the protocol and to signconsent forms Also four stool collection kits will be handedto the participant After signing the consent form theFitzpatrick skin type will be assessed with the hand of aquestionnaire about the sun exposure habits The participant is responsible to collect two stool samplesduring the week prior to the first light exposure and store itin her freezer at home On the Monday of the first NB-UVB exposure the researchcoordinator will confirm that a stool sample is collected bythe participant The participant will be referred to the lab atLife Labs to collect one blood sample (one tube of 15 mlapproximately one table spoon full) and will later go to TheSkin Care Centre at VGH where the participants will beassessed under supervision of dr Harvey Lui MD for theirfirst full body NB-UVB exposure The participants will wearspecialised goggles to protect the eyes from the UVB raysand wear broad spectrum sunscreen on face and hands toprotect these areas from the light The NB-UVB lightexposure will happen in a full body cabin like an uprighttanning bed and will take no longer than 5 minutes A timewill be scheduled for the next two sessions with theparticipants On Wednesday and Friday the participant willreceive a NB-UVB dose that is 10 higher than the fisrtvisit if tolerated well Description of blood collection procedure at Life Labs Ablood sample will be taken by first applying a tourniquet tothe upper arm The skin on the inner side of the elbow willbe sterilised and a small sterile needle will be inserted intothe vein Two blood collection tubes will then be attached tothe needle which will fill with blood When the tube is fullthe needle will be removed A plaster or small bandage will be applied to cover the site where the needle

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was removed Blood samples will be marked with their study identifiersand analysed in Life labs for of serum 25-hydroxy vitaminD3 according to Standards Council of Canadarsquos GoodLaboratory Practice (GLP) principles and Good ClinicalPractice (GCP) The participant is responsible to collect tw stool samplesthe week after the three NB-UVB light exposures and storeit in the freezer The research coordinator will contact theparticipant when and where to pick up the stool samples orparticipant can drop them off at their own convenience atthe Skin Care Centre during on Monday Wednesday andFriday nights The stool samples that are collected from the participantwill be stored in the BCCHR in a -80C freezer in a lockedlab until all samples from all participants are collectedOnce all stool samples are collected they will be send offto the Stintzi Lab at the University of Ottawa for 16S rRNAsequencing The results will be analysed and stored on theBCCHR password-secured computer

6 Participant Information and Consent Process - Clinical Study [View Form]

61 Time to Participate Howmuch time will a participant beasked to dedicate to the projectbeyond that needed for normalcare

The first visit to sign the consent form and do the Skin typeassessment will take approximately 20 minutes The visitfor the first UVB exposure will take approx 20 minutes toreview the exposure methods The next two visits will take approximately 10-12 minuteseach The visits for the blood draws will take about 30 minutesdepending on the amount of waiting time of the Life Labslocation The total time the participant will spend to this study will be2 hours minutes

62 Time to Participate ndashNormalControl Participants Ifapplicable how much time will anormalcontrol volunteer beasked to dedicate to the project

Each participant will be treated similarly

63 RisksHarms Describe whatis known about the risks(harms) of the proposedresearch

The exposure to NB-UVB light will turn the skin slightly pinkfor 1-2 days NB-UVB is ultraviolet radiation and couldcause long term effects after excessive exposure like skinageing and skin cancer The exposure from this study isequivalent to 5 min sun exposure during a summerrsquos dayper visit and is unlikely to have any long-term effects Short-term side effects may include skin redness skin drynesstriggering of a cold sore All of these effects are minor and

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will resolve usually within a week In rare cases the skinmight turn red and gives a sun burn-like sensation In thiscase the sensation will fade away over the next days Theparticipant should contact the researcher in this case Although minimal there is a 05 risk of bleeding from theneedle site If this occurs the subject can be given apressure bandage The risks of blood draw also includespain andor discomfort bruising fainting andor lightheaded sensation and the rare possibility of infection

64 Benefits Describe anypotential benefits to theparticipant that could arise fromhis or her participation in theproposed research

Exposure to NB-UVB will produce vitamin D in your skinthat helps against seasonal affective disorder (SAD) and isimportant for your general health

65 Reimbursement Describeany reimbursement for expenses(eg meals parkingmedications) orpaymentsincentivesgifts-in-kind(eg honoraria gifts prizescredits) to be offered to theparticipants Provide full detailsof the amounts paymentschedules and value of gifts-in-kind

There is a $750 budget for this study for the 30 testparticipants Each participant will be given a $25 gift-certificate when the stool samples are collected and theparticipant is done with the study requirements

66 Obtaining Consent SpecifyA) who will explain the consentform B) who will consentparticipants C) Include details ofwhere the consent will beobtained and under whatcircumstances and D) therelationship of the personobtaining consent andparticipant

Once the potential participants agree to participate to thestudy by email the consent form will be explained in personby the research coordinator The research coordinator willbe able to answer all questions about possible concernsand about the procedure The consent form will bediscussed in person with the participant in an office settingin the Skin Care Center Once the participants sign theconsent form they agree to be a part of the study Theparticipants will get the stool collection kits at that time andwill come back for the further procedures one week laterThe participant is free to withdraw from the study at anygiven time for the duration of the study The physicians at the Skin Care Centre will go through theprocedures with the participant and is able to answer anyquestions regarding the UVB exposure

67A WaiverAlteration ofConsent If you are asking for awaiver or an alteration of therequirement for participantinformed consent please justifythe waiver or alteration andexplain how the study meets allthe criteria on the right Pleaseclick Guidance Notes on rightand ensure that you address

There will be no waiver

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each criteria individually Includethe corresponding letter (A B CD E) before each answer67B Waiver of Consent inIndividual Medical EmergenciesIf you are asking for a waiver oran alteration of the requirementfor participant informed consentin individual medicalemergencies please justify thewaiver or alteration and explainhow the study meets all thecriteria on the right Please clickGuidance Notes on right andensure that you address eachcriteria individually Include thecorresponding letter (A B C DE) before each answer

NA

68 Time to Consent How longafter being provided with detailedinformationconsent form aboutthe study will the participanthave to decide whether or not toparticipate Provide yourrationale for the amount of timegiven

Once the participant contacts the study by email theconsent form will be sent to them by email to read throughbefore the first meeting The research coordinator willdiscuss the contents of the consent form with theparticipant one week prior to the UVB light exposureprotocol Thus participants will have 1-2 weeks to reviewthe consent form before making a decision aboutparticipation

69 Capacity to Consent Willevery participant have thecapacity to give fully informedconsent on hisher own behalfPlease click Select to completethe question and view furtherdetails

Will theparticipanthave thecapacityto givefullyinformedconsent

Details ofthe natureof theincapacity

If notwhowillconsentonhisherbehalf

If not willheshe beable to giveassent toparticipate

If Yesexplainhowassentwill besought

Yes [Details]

610 Renewal of ConsentDescribe any situation in whichthe renewal of consent for thisresearch might be appropriateand how this would take place

There are no plans for renewal of consent No furthercontact is required after obtaining the samples All samplesand data will be de-identified on collection and cannot betracked back to the subjects

611 Provisions for ConsentWhat provisions are planned forparticipants or those consentingon a participants behalf to havespecial assistance if neededduring the consent process (egconsent forms in Braille or inlanguages other than English)

Participants have to be able bodied to be able to participatein order to receive the UVB exposure Subjects with nounderstanding of the English language will not beapproached for involvement in the study unless a translatoris present who can converse in the first language of thesubject

612 Restrictions on DisclosureDescribe any restrictions

There are no restrictions on disclosure of information

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regarding the disclosure ofinformation to researchparticipants (during or at the endof the study) that the sponsorhas placed on investigatorsincluding those related to thepublication of results Alsoindicate any plans forcommunicating study results toparticipants7 Number of Participants and Study Drugs - Clinical Study [View Form]

71 Multi-Centre Studies 71A Is this a multi-centre study(involves centres outside ofthose applied for under thisApproval)

no

If known please list the othersites below

71B Is this study beingsubmitted for ethical approval toany other Research EthicsBoard

DescriptionNo

If yes please provide the nameof the REB(s) and if availablecontact information

72 Number of Participants 72A How many participants(including controls) will beenrolled in the entire study (iethe entire study world-wide)

30

72B How many participants(including controls) will beenrolled at institutions coveredby this Research EthicsApproval (ie only at theinstitutions covered by thisapproval)

30

72C Of these how many arecontrols 0

72D Please enter anyadditional comments

73 Drug approvals Enter thegeneric name of anyinvestigational drug(s) not yetapproved or any marketeddrug(s) used outside of itsapproved indication

NA

74 Marketed Drugs Enter thename of any marketed drug(s)

NA

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used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

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amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

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ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

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files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

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Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

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on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

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will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

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112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 3: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

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Is role in study eg statisticiansupervisor adviser student etc14 Additional Study TeamMembers - Online Access Listthe additional study teammembers who WILL have onlineaccess to read amend andtrack the application but WILLNOT be listed on the certificateof approval

Last Name First Name InstitutionDepartment Rank

Role in Study

15 Additional Study TeamMembers - No Online Access Click Add to list study teammembers who WILL NOT haveonline access to the applicationand will NOT be listed on thecertificate of approval

LastName

FirstName

Institution Department

Rank JobTitle

Email Address

Stintzi AlainFaculty ofMedicineUniversity ofOttawa

Vice-Dean astintziuottawaca

Role in Study Tri Council Policy Statement2(TCPS2) Tutorial All study teammembers (including but notlimited to faculty undergraduateand graduate students medicalresidents and research staff) arerequired to complete the TCPS2Tutorial (CORE) beforesubmission Indicate completionof the TCPS2 (CORE) tutorialbelow 16A All Facultyincluding hospital appointmentequivalents deemed a PI by anaffiliated institution or by a Dean

Yes

16B All Other Study Teammembers Yes

Comments 17 Project Title Enter the titleof this research study as it willappear on the certificate Ifapplicable include the protocolnumber in brackets at the end ofthe title If this is a class-basedproject see guidance on theright Title given must match thetitle on all study documents

Intestinal Microbiota Changes after Ultraviolet Radiation BExposure

18 Project Nickname Enter anickname for this study Whatwould you like this study to be

UVB skin to gut study

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known as to the PrincipalInvestigator and study team2 Study Dates and Funding - Human Ethics [View Form]

You plan to start collecting dataimmediately after obtainingethics and any other requiredapprovals (the start date on theethics certificate will reflect theapproval date)

yes

You plan to start data collectionat a later date ie 2 months ormore after approvals areobtained Click the calendar iconbelow to select the dates(Internet Explorer) or enter thedates manually using the formatyyyy-mm-dd Estimated startdate

21 B Estimated end date 8312018 22A Types of Funds Pleaseselect the applicable box(es)below to indicate the type(s) offunding you are receiving toconduct this research You mustthen complete section 23 andorsection 24 for the name of thesource of the funds to be listedon the certificate of approval

Grant

22B For Industry Sponsoredstudies please provide asponsor contact

22C Please enter anyapplicable information aboutyour funding which is not alreadyshown in Box 23 or 24(including funding applied for butnot yet received)

23 Research FundingApplicationAward Associatedwith the Study that wasSubmitted to the UBC Office ofResearch Services Please clickAdd to identify the researchfunding applicationawardassociated with this studySelecting Add will list thesources of all research fundingapplications that have beensubmitted by the PI (and theperson completing thisapplication if different from the

UBCNumber Title Sponsor

F12-04845

Vitamin D - A regulator ofhost-microbe interactionsin the mammalian GItract

Natural Sciences andEngineering ResearchCouncil of Canada(NSERC)

F17-05461

UVB influences thehuman microbiota a pilotstudy

BC Childrens HospitalResearch Institute

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PI) If the research fundingapplicationaward associatedwith this study is not listed belowplease enter those details inquestion 2424 Research FundingApplicationAward Associatedwith the Study not listed inquestion 23 Please click Addto enter the details for theresearch fundingapplicationaward associatedwith this study that is not listed inquestion 23 When you pressAdd you can do a search foryour funding award by doing asearch in the Sponsor box - over7000 options are listed

UBC Number Title Sponsor

25A Is this a DHHS grant (Toview a list of DHHS fundingagencies click on add in 25Bbelow)

no

25B If yes please select theappropriate DHHS fundingagency from the selection boxand attach the grant to box 98of the application

DHHS Sponsor List Order Active

Attach DHHS Grant Applicationfor each sponsor listed above

26 Conflict of Interest Conflictsof Interest (COIs) can arisenaturally from an Investigatorrsquosengagement inside and outsidethe University and the mereexistence of a COI or theperception of a COI does notnecessarily imply wrongdoing onanyonersquos part Nonetheless realand perceived COI must berecognized disclosed andassessed This question asksInvestigators to disclose COIsthat may relate to the researchstudy that is the subject of theREB application Do thePrincipal Investigator Co-Investigators andor their relatedparties (defined at s812 UBCPolicy 97) have any personalinterest(s) that couldcompromise or reasonably beperceived to compromise the

no

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objective conduct of the researchor the integrity of the datagenerated by the studyPersonal interests may includebusiness commercial orfinancial interests as well aspersonal matters and careerinterests4 Study Type - Human Ethics Application [View Form]

41 UBC Research Ethics Board Indicate which UBC ResearchEthics Board you are applying toand the type of study you areapplying for

UBC Clinical Research Ethics Board

NA no

42A Institutions and Sites forStudy

Institution SiteVancouver Coastal Health(VCHRIVCHA)

Vancouver GeneralHospital

Childrens and Womens HealthCentre of BC (incl Sunny Hill)

BC Childrens Hospital(includes ResearchInstitute)

42B Please enter any otherlocations where the research willbe conducted under thisResearch Ethics Approval (egName of privately owned cliniccommunity centre schoolclassroom participants home inthe field - provide details)

The data will be collected in The Skin Care Center locatedat Vancouver General Hospital and data analysis will bedone by Life Labs and by the University of Ottawa incollaboration with professor Stintzi Data storage will bedone in the BCCHR institute

4 Clinical Study Review Type [View Form]

43 Relationship with otherproposals 43A If this proposalis closely linked to any otherproposalpreviouslysimultaneouslysubmitted enter the ResearchEthics Board number of thatproposal

No

43B If applicable pleasedescribe the relationshipbetween this proposal and thepreviouslysimultaneouslysubmitted proposal listed above

43C Have you received anyinformation or are you aware ofany rejection of this study by anyResearch Ethics Board If yesplease provide known details

no

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and attach any available relevantdocumentation in question 9743D Will biological materialsbe collected or analyzed by UBCresearchers or a UBC researchlab If yes please provide theUBC Biosafety Permit Number

No

43E Will radioisotopes beused in this project If yesprovide the UBC RadiationPermit Number

NA

44 Level of Risk Afterreviewing the minimal riskguidance notes and the criteriafor minimal risk does this studyqualify for minimal risk reviewNote that all studies which do notfall into the minimal risk categorywill undergo full board review

no

Peer Review If this researchproposal has received anyindependentscientificmethodological peerreview please include thenames of committees orindividuals involved in thereview State whether the peerreview process is ongoing orcompleted All above minimalrisk studies generally require apeer review 45A Externalpeer review details

NO

45B Internal (UBC or hospital)peer review details Yes dr Vincent Ho MD FRCPC FRCP completed

45C If this research proposalhas NOT received anyindependentscientificmethodological peerreview explain why no reviewhas taken place

NA

46 Multi-jurisdictional studies Please read and review theguidance note on the right priorto completing this question Isthis study a multi-jurisdictionalstudy that will also require reviewby one or more REB with whichthe University of BritishColumbia has a collaborativereview agreement (See theguidance to the right for detailsabout the harmonized process)

no

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Simon Fraser University University of Alberta Universityof Northern British Columbia Northern Health Authority University of Saskatchewan University of Victoria IslandHealth Authority Fraser HealthAuthority Interior HealthAuthority Note If submitting anamendment for an alreadyapproved study you mustrespond ldquoNordquo to this question)4 Clinical Study Review Type (Q 47 48) [View Form]

47A Creation of a Registry(Data or Tissue Bank) Doesthis study involve the creation ofa registry (data or tissue bank)for future use in other research[if no skip to 48]

no

47B Is the purpose of thisapplication exclusively to obtainapproval for the creation of aresearch database registry ortissue bank [Note if the creationof the database or registry ortissue repository is part of abigger project also included inthis application you mustanswer no below]

no

Clinical Chart Review 48A Isthis an application for researchrequiring access to clinical chartsOR data from registries ordatabases such as PopData BCor Pharmanet

no

48B Insert the date range ofthe chartsdata to be included inthis research (eg 7 September2005 ndash 6 September 2011)

48C Is this study exclusively aretrospective chart review wherethe only source of data will bemedical chartsrecords that arecurrently in existence (ie willpre-date the date of your initialethics approval)

48D Are you collecting andretaining personally identifiableinformation to be a part of thedata set

48E Is this a retrospective

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chart review study for whichparticipant consent will beobtained5 Summary of Study and Recruitment - Clinical Study [View Form]

51 Study Summary 51A Provide a short summary of theproject written in lay languagesuitable for non-scientific REBmembers DO NOT exceed 100words and do not cut and pastedirectly from the study protocol

This research will explore the potential effects of Narrow-Band Ultra Violet B (NB-UVB) radiation on the intestinalmicrobiota composition and confirm a regulatory skin-to-gutaxis during baseline conditions Changes in the intestinalmicrobiota composition caused by NB-UVB phototherapycould be beneficial for patients with chronicauto-inflammatory diseases like IBD by removing dangerousbacteria increasing beneficial bacteria and ultimatelymodulating immune responses

51B Summarize the researchproposal Purpose Hypothesis Justification ObjectivesResearch Design and StatisticalAnalysis

Purpose To explore the potential effects of Narrow-Band Ultra VioletB (NB-UVB) radiation on the intestinal microbiotacomposition in humans and confirm a regulatory skin-to-gutaxis during baseline conditions Hypothesis Humans exposed to UVB-NB light will show changes in theintestinal microbiota composition with selection of certainphyla of bacteria Justification To date there is no data that describes a biologicalresponse to UVB light in the body that affects the intestinalmicrobiota Changes in the intestinal microbiotacomposition caused by NB-UVB phototherapy could bebeneficial for patients with chronicauto-inflammatorydiseases like IBD by removing dangerous bacteriaincreasing beneficial bacteria and ultimately modulatingimmune responses Objectives 1 Establish if there is an skin regulatory response towardsNB-UVB light in humans 2 Examine what changes in the microbiota compositioncan be observed on bacterial phyla and class level 3 Determine if this research is worth pursuing in a largercohort Research design During the first visit the skin type will be assessed by usingthe Fitzpatrick skin type questionnaire Subsequently subjects will be exposed three times withinone week to full body NB-UVB light in The Skin CareCentre to a sub erythemic dose (cause slight redness of theskin but not burning) The exposures will happen during thewinter months to prevent UVB exposure from the sunduring daily activities to interfere with our observationsStool samples will be collected before the first exposure(2x) and after the last exposure (2x) to analyse the

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microbiota composition Also serum vitamin D (25-hydroxyvitamin D) will be measured before and after the UVBexposure as a marker of previous UVB exposure before theexperiment Subjects will be healthy Caucasian females between 19-40years of age with a Fitzpatrick skin type I II or III tominimise the variability in skin responses towards the UVB-NB light since fair skin colour is less adapted to absorb theUVB radiation than dark coloured skin The microbiota composition will be analysed with 16S rRNAIllumina sequencing and calculated for differentialabundance on phylum level Statistical analysis The statistical analysis will focus the personal microbiotacomposition variation after NB-UVB light exposure incomparison to before the UVB light exposure Because wecollect two samples before and two samples after the UVBexposures each individual can serve as her own internalcontrol

52 Inclusion Criteria InclusionCriteria Describe theparticipants being selected forthis study and list the criteria fortheir inclusion For researchinvolving human pluripotent stemcells provide a detaileddescription of the stem cellsbeing used in the research

Healthy Caucasian females between 19-40 years of age Fitzpatrick skin type I II or III (see box 98A for Fitzpatrickskin type assessment)

53 Exclusion Criteria Exclusion Criteria Describewhich potential participants willbe excluded from participationand list the criteria for theirexclusion

The participants will be excluded if they have skin photosensitivity or taking medication that promotes photosensitivity of their skin Also participants that have been onvacation to a sunny destination since October 2017 or visittanning beds on a regular basis will be excluded becausethey have been exposed to UVB radiation

54 Recruitment Provide adetailed description of themethod of recruitment Includewhere applicable A) Who willcontact prospective participantsB) by what means this will bedone C) How prospectiveparticipants will be identified D)Ensure that any letters of initialcontact or other recruitmentmaterials are attached to thissubmission on Page 9

The recruitment will be done via social media withFacebook (UVBstudy page) The recruitment advertisementis included in the submission The researcher will contactprospective participants after they voluntarily contacted thestudy email address UVBstudyalumniubcca Initial contact will be through email conversation until thepotential participant expresses interest participating byemail Once the participant has signed the consent form astudy identifier will be assigned to the participant to protectthe individuals identity

55 Recruitment ofNormalControl Participants Describe how prospectivenormalcontrol participants will

Each participant will serve as her own control Allparticipants will be recruited the same way

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be identified contacted andrecruited if the method differsfrom the above56 Use of Records If existingrecords (eg health recordsclinical lists or otherrecordsdatabases) will be usedto IDENTIFY potentialparticipants or COLLECT DATAplease describe how permissionto access this information and tocollect and use this informationwill be obtained

No existing records will be used for this study

57 Summary of StudyProcedures

Participants will contact the study coordinator and will beinvited to participate by and email that will be sent alongwith the consent form A first meeting will be set upbetween the research coordinator and the participant at theSkin Care Center to explain the protocol and to signconsent forms Also four stool collection kits will be handedto the participant After signing the consent form theFitzpatrick skin type will be assessed with the hand of aquestionnaire about the sun exposure habits The participant is responsible to collect two stool samplesduring the week prior to the first light exposure and store itin her freezer at home On the Monday of the first NB-UVB exposure the researchcoordinator will confirm that a stool sample is collected bythe participant The participant will be referred to the lab atLife Labs to collect one blood sample (one tube of 15 mlapproximately one table spoon full) and will later go to TheSkin Care Centre at VGH where the participants will beassessed under supervision of dr Harvey Lui MD for theirfirst full body NB-UVB exposure The participants will wearspecialised goggles to protect the eyes from the UVB raysand wear broad spectrum sunscreen on face and hands toprotect these areas from the light The NB-UVB lightexposure will happen in a full body cabin like an uprighttanning bed and will take no longer than 5 minutes A timewill be scheduled for the next two sessions with theparticipants On Wednesday and Friday the participant willreceive a NB-UVB dose that is 10 higher than the fisrtvisit if tolerated well Description of blood collection procedure at Life Labs Ablood sample will be taken by first applying a tourniquet tothe upper arm The skin on the inner side of the elbow willbe sterilised and a small sterile needle will be inserted intothe vein Two blood collection tubes will then be attached tothe needle which will fill with blood When the tube is fullthe needle will be removed A plaster or small bandage will be applied to cover the site where the needle

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was removed Blood samples will be marked with their study identifiersand analysed in Life labs for of serum 25-hydroxy vitaminD3 according to Standards Council of Canadarsquos GoodLaboratory Practice (GLP) principles and Good ClinicalPractice (GCP) The participant is responsible to collect tw stool samplesthe week after the three NB-UVB light exposures and storeit in the freezer The research coordinator will contact theparticipant when and where to pick up the stool samples orparticipant can drop them off at their own convenience atthe Skin Care Centre during on Monday Wednesday andFriday nights The stool samples that are collected from the participantwill be stored in the BCCHR in a -80C freezer in a lockedlab until all samples from all participants are collectedOnce all stool samples are collected they will be send offto the Stintzi Lab at the University of Ottawa for 16S rRNAsequencing The results will be analysed and stored on theBCCHR password-secured computer

6 Participant Information and Consent Process - Clinical Study [View Form]

61 Time to Participate Howmuch time will a participant beasked to dedicate to the projectbeyond that needed for normalcare

The first visit to sign the consent form and do the Skin typeassessment will take approximately 20 minutes The visitfor the first UVB exposure will take approx 20 minutes toreview the exposure methods The next two visits will take approximately 10-12 minuteseach The visits for the blood draws will take about 30 minutesdepending on the amount of waiting time of the Life Labslocation The total time the participant will spend to this study will be2 hours minutes

62 Time to Participate ndashNormalControl Participants Ifapplicable how much time will anormalcontrol volunteer beasked to dedicate to the project

Each participant will be treated similarly

63 RisksHarms Describe whatis known about the risks(harms) of the proposedresearch

The exposure to NB-UVB light will turn the skin slightly pinkfor 1-2 days NB-UVB is ultraviolet radiation and couldcause long term effects after excessive exposure like skinageing and skin cancer The exposure from this study isequivalent to 5 min sun exposure during a summerrsquos dayper visit and is unlikely to have any long-term effects Short-term side effects may include skin redness skin drynesstriggering of a cold sore All of these effects are minor and

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will resolve usually within a week In rare cases the skinmight turn red and gives a sun burn-like sensation In thiscase the sensation will fade away over the next days Theparticipant should contact the researcher in this case Although minimal there is a 05 risk of bleeding from theneedle site If this occurs the subject can be given apressure bandage The risks of blood draw also includespain andor discomfort bruising fainting andor lightheaded sensation and the rare possibility of infection

64 Benefits Describe anypotential benefits to theparticipant that could arise fromhis or her participation in theproposed research

Exposure to NB-UVB will produce vitamin D in your skinthat helps against seasonal affective disorder (SAD) and isimportant for your general health

65 Reimbursement Describeany reimbursement for expenses(eg meals parkingmedications) orpaymentsincentivesgifts-in-kind(eg honoraria gifts prizescredits) to be offered to theparticipants Provide full detailsof the amounts paymentschedules and value of gifts-in-kind

There is a $750 budget for this study for the 30 testparticipants Each participant will be given a $25 gift-certificate when the stool samples are collected and theparticipant is done with the study requirements

66 Obtaining Consent SpecifyA) who will explain the consentform B) who will consentparticipants C) Include details ofwhere the consent will beobtained and under whatcircumstances and D) therelationship of the personobtaining consent andparticipant

Once the potential participants agree to participate to thestudy by email the consent form will be explained in personby the research coordinator The research coordinator willbe able to answer all questions about possible concernsand about the procedure The consent form will bediscussed in person with the participant in an office settingin the Skin Care Center Once the participants sign theconsent form they agree to be a part of the study Theparticipants will get the stool collection kits at that time andwill come back for the further procedures one week laterThe participant is free to withdraw from the study at anygiven time for the duration of the study The physicians at the Skin Care Centre will go through theprocedures with the participant and is able to answer anyquestions regarding the UVB exposure

67A WaiverAlteration ofConsent If you are asking for awaiver or an alteration of therequirement for participantinformed consent please justifythe waiver or alteration andexplain how the study meets allthe criteria on the right Pleaseclick Guidance Notes on rightand ensure that you address

There will be no waiver

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each criteria individually Includethe corresponding letter (A B CD E) before each answer67B Waiver of Consent inIndividual Medical EmergenciesIf you are asking for a waiver oran alteration of the requirementfor participant informed consentin individual medicalemergencies please justify thewaiver or alteration and explainhow the study meets all thecriteria on the right Please clickGuidance Notes on right andensure that you address eachcriteria individually Include thecorresponding letter (A B C DE) before each answer

NA

68 Time to Consent How longafter being provided with detailedinformationconsent form aboutthe study will the participanthave to decide whether or not toparticipate Provide yourrationale for the amount of timegiven

Once the participant contacts the study by email theconsent form will be sent to them by email to read throughbefore the first meeting The research coordinator willdiscuss the contents of the consent form with theparticipant one week prior to the UVB light exposureprotocol Thus participants will have 1-2 weeks to reviewthe consent form before making a decision aboutparticipation

69 Capacity to Consent Willevery participant have thecapacity to give fully informedconsent on hisher own behalfPlease click Select to completethe question and view furtherdetails

Will theparticipanthave thecapacityto givefullyinformedconsent

Details ofthe natureof theincapacity

If notwhowillconsentonhisherbehalf

If not willheshe beable to giveassent toparticipate

If Yesexplainhowassentwill besought

Yes [Details]

610 Renewal of ConsentDescribe any situation in whichthe renewal of consent for thisresearch might be appropriateand how this would take place

There are no plans for renewal of consent No furthercontact is required after obtaining the samples All samplesand data will be de-identified on collection and cannot betracked back to the subjects

611 Provisions for ConsentWhat provisions are planned forparticipants or those consentingon a participants behalf to havespecial assistance if neededduring the consent process (egconsent forms in Braille or inlanguages other than English)

Participants have to be able bodied to be able to participatein order to receive the UVB exposure Subjects with nounderstanding of the English language will not beapproached for involvement in the study unless a translatoris present who can converse in the first language of thesubject

612 Restrictions on DisclosureDescribe any restrictions

There are no restrictions on disclosure of information

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regarding the disclosure ofinformation to researchparticipants (during or at the endof the study) that the sponsorhas placed on investigatorsincluding those related to thepublication of results Alsoindicate any plans forcommunicating study results toparticipants7 Number of Participants and Study Drugs - Clinical Study [View Form]

71 Multi-Centre Studies 71A Is this a multi-centre study(involves centres outside ofthose applied for under thisApproval)

no

If known please list the othersites below

71B Is this study beingsubmitted for ethical approval toany other Research EthicsBoard

DescriptionNo

If yes please provide the nameof the REB(s) and if availablecontact information

72 Number of Participants 72A How many participants(including controls) will beenrolled in the entire study (iethe entire study world-wide)

30

72B How many participants(including controls) will beenrolled at institutions coveredby this Research EthicsApproval (ie only at theinstitutions covered by thisapproval)

30

72C Of these how many arecontrols 0

72D Please enter anyadditional comments

73 Drug approvals Enter thegeneric name of anyinvestigational drug(s) not yetapproved or any marketeddrug(s) used outside of itsapproved indication

NA

74 Marketed Drugs Enter thename of any marketed drug(s)

NA

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used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

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amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

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ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

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files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

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Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

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on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

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will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

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112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 4: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

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known as to the PrincipalInvestigator and study team2 Study Dates and Funding - Human Ethics [View Form]

You plan to start collecting dataimmediately after obtainingethics and any other requiredapprovals (the start date on theethics certificate will reflect theapproval date)

yes

You plan to start data collectionat a later date ie 2 months ormore after approvals areobtained Click the calendar iconbelow to select the dates(Internet Explorer) or enter thedates manually using the formatyyyy-mm-dd Estimated startdate

21 B Estimated end date 8312018 22A Types of Funds Pleaseselect the applicable box(es)below to indicate the type(s) offunding you are receiving toconduct this research You mustthen complete section 23 andorsection 24 for the name of thesource of the funds to be listedon the certificate of approval

Grant

22B For Industry Sponsoredstudies please provide asponsor contact

22C Please enter anyapplicable information aboutyour funding which is not alreadyshown in Box 23 or 24(including funding applied for butnot yet received)

23 Research FundingApplicationAward Associatedwith the Study that wasSubmitted to the UBC Office ofResearch Services Please clickAdd to identify the researchfunding applicationawardassociated with this studySelecting Add will list thesources of all research fundingapplications that have beensubmitted by the PI (and theperson completing thisapplication if different from the

UBCNumber Title Sponsor

F12-04845

Vitamin D - A regulator ofhost-microbe interactionsin the mammalian GItract

Natural Sciences andEngineering ResearchCouncil of Canada(NSERC)

F17-05461

UVB influences thehuman microbiota a pilotstudy

BC Childrens HospitalResearch Institute

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PI) If the research fundingapplicationaward associatedwith this study is not listed belowplease enter those details inquestion 2424 Research FundingApplicationAward Associatedwith the Study not listed inquestion 23 Please click Addto enter the details for theresearch fundingapplicationaward associatedwith this study that is not listed inquestion 23 When you pressAdd you can do a search foryour funding award by doing asearch in the Sponsor box - over7000 options are listed

UBC Number Title Sponsor

25A Is this a DHHS grant (Toview a list of DHHS fundingagencies click on add in 25Bbelow)

no

25B If yes please select theappropriate DHHS fundingagency from the selection boxand attach the grant to box 98of the application

DHHS Sponsor List Order Active

Attach DHHS Grant Applicationfor each sponsor listed above

26 Conflict of Interest Conflictsof Interest (COIs) can arisenaturally from an Investigatorrsquosengagement inside and outsidethe University and the mereexistence of a COI or theperception of a COI does notnecessarily imply wrongdoing onanyonersquos part Nonetheless realand perceived COI must berecognized disclosed andassessed This question asksInvestigators to disclose COIsthat may relate to the researchstudy that is the subject of theREB application Do thePrincipal Investigator Co-Investigators andor their relatedparties (defined at s812 UBCPolicy 97) have any personalinterest(s) that couldcompromise or reasonably beperceived to compromise the

no

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objective conduct of the researchor the integrity of the datagenerated by the studyPersonal interests may includebusiness commercial orfinancial interests as well aspersonal matters and careerinterests4 Study Type - Human Ethics Application [View Form]

41 UBC Research Ethics Board Indicate which UBC ResearchEthics Board you are applying toand the type of study you areapplying for

UBC Clinical Research Ethics Board

NA no

42A Institutions and Sites forStudy

Institution SiteVancouver Coastal Health(VCHRIVCHA)

Vancouver GeneralHospital

Childrens and Womens HealthCentre of BC (incl Sunny Hill)

BC Childrens Hospital(includes ResearchInstitute)

42B Please enter any otherlocations where the research willbe conducted under thisResearch Ethics Approval (egName of privately owned cliniccommunity centre schoolclassroom participants home inthe field - provide details)

The data will be collected in The Skin Care Center locatedat Vancouver General Hospital and data analysis will bedone by Life Labs and by the University of Ottawa incollaboration with professor Stintzi Data storage will bedone in the BCCHR institute

4 Clinical Study Review Type [View Form]

43 Relationship with otherproposals 43A If this proposalis closely linked to any otherproposalpreviouslysimultaneouslysubmitted enter the ResearchEthics Board number of thatproposal

No

43B If applicable pleasedescribe the relationshipbetween this proposal and thepreviouslysimultaneouslysubmitted proposal listed above

43C Have you received anyinformation or are you aware ofany rejection of this study by anyResearch Ethics Board If yesplease provide known details

no

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and attach any available relevantdocumentation in question 9743D Will biological materialsbe collected or analyzed by UBCresearchers or a UBC researchlab If yes please provide theUBC Biosafety Permit Number

No

43E Will radioisotopes beused in this project If yesprovide the UBC RadiationPermit Number

NA

44 Level of Risk Afterreviewing the minimal riskguidance notes and the criteriafor minimal risk does this studyqualify for minimal risk reviewNote that all studies which do notfall into the minimal risk categorywill undergo full board review

no

Peer Review If this researchproposal has received anyindependentscientificmethodological peerreview please include thenames of committees orindividuals involved in thereview State whether the peerreview process is ongoing orcompleted All above minimalrisk studies generally require apeer review 45A Externalpeer review details

NO

45B Internal (UBC or hospital)peer review details Yes dr Vincent Ho MD FRCPC FRCP completed

45C If this research proposalhas NOT received anyindependentscientificmethodological peerreview explain why no reviewhas taken place

NA

46 Multi-jurisdictional studies Please read and review theguidance note on the right priorto completing this question Isthis study a multi-jurisdictionalstudy that will also require reviewby one or more REB with whichthe University of BritishColumbia has a collaborativereview agreement (See theguidance to the right for detailsabout the harmonized process)

no

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Simon Fraser University University of Alberta Universityof Northern British Columbia Northern Health Authority University of Saskatchewan University of Victoria IslandHealth Authority Fraser HealthAuthority Interior HealthAuthority Note If submitting anamendment for an alreadyapproved study you mustrespond ldquoNordquo to this question)4 Clinical Study Review Type (Q 47 48) [View Form]

47A Creation of a Registry(Data or Tissue Bank) Doesthis study involve the creation ofa registry (data or tissue bank)for future use in other research[if no skip to 48]

no

47B Is the purpose of thisapplication exclusively to obtainapproval for the creation of aresearch database registry ortissue bank [Note if the creationof the database or registry ortissue repository is part of abigger project also included inthis application you mustanswer no below]

no

Clinical Chart Review 48A Isthis an application for researchrequiring access to clinical chartsOR data from registries ordatabases such as PopData BCor Pharmanet

no

48B Insert the date range ofthe chartsdata to be included inthis research (eg 7 September2005 ndash 6 September 2011)

48C Is this study exclusively aretrospective chart review wherethe only source of data will bemedical chartsrecords that arecurrently in existence (ie willpre-date the date of your initialethics approval)

48D Are you collecting andretaining personally identifiableinformation to be a part of thedata set

48E Is this a retrospective

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chart review study for whichparticipant consent will beobtained5 Summary of Study and Recruitment - Clinical Study [View Form]

51 Study Summary 51A Provide a short summary of theproject written in lay languagesuitable for non-scientific REBmembers DO NOT exceed 100words and do not cut and pastedirectly from the study protocol

This research will explore the potential effects of Narrow-Band Ultra Violet B (NB-UVB) radiation on the intestinalmicrobiota composition and confirm a regulatory skin-to-gutaxis during baseline conditions Changes in the intestinalmicrobiota composition caused by NB-UVB phototherapycould be beneficial for patients with chronicauto-inflammatory diseases like IBD by removing dangerousbacteria increasing beneficial bacteria and ultimatelymodulating immune responses

51B Summarize the researchproposal Purpose Hypothesis Justification ObjectivesResearch Design and StatisticalAnalysis

Purpose To explore the potential effects of Narrow-Band Ultra VioletB (NB-UVB) radiation on the intestinal microbiotacomposition in humans and confirm a regulatory skin-to-gutaxis during baseline conditions Hypothesis Humans exposed to UVB-NB light will show changes in theintestinal microbiota composition with selection of certainphyla of bacteria Justification To date there is no data that describes a biologicalresponse to UVB light in the body that affects the intestinalmicrobiota Changes in the intestinal microbiotacomposition caused by NB-UVB phototherapy could bebeneficial for patients with chronicauto-inflammatorydiseases like IBD by removing dangerous bacteriaincreasing beneficial bacteria and ultimately modulatingimmune responses Objectives 1 Establish if there is an skin regulatory response towardsNB-UVB light in humans 2 Examine what changes in the microbiota compositioncan be observed on bacterial phyla and class level 3 Determine if this research is worth pursuing in a largercohort Research design During the first visit the skin type will be assessed by usingthe Fitzpatrick skin type questionnaire Subsequently subjects will be exposed three times withinone week to full body NB-UVB light in The Skin CareCentre to a sub erythemic dose (cause slight redness of theskin but not burning) The exposures will happen during thewinter months to prevent UVB exposure from the sunduring daily activities to interfere with our observationsStool samples will be collected before the first exposure(2x) and after the last exposure (2x) to analyse the

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microbiota composition Also serum vitamin D (25-hydroxyvitamin D) will be measured before and after the UVBexposure as a marker of previous UVB exposure before theexperiment Subjects will be healthy Caucasian females between 19-40years of age with a Fitzpatrick skin type I II or III tominimise the variability in skin responses towards the UVB-NB light since fair skin colour is less adapted to absorb theUVB radiation than dark coloured skin The microbiota composition will be analysed with 16S rRNAIllumina sequencing and calculated for differentialabundance on phylum level Statistical analysis The statistical analysis will focus the personal microbiotacomposition variation after NB-UVB light exposure incomparison to before the UVB light exposure Because wecollect two samples before and two samples after the UVBexposures each individual can serve as her own internalcontrol

52 Inclusion Criteria InclusionCriteria Describe theparticipants being selected forthis study and list the criteria fortheir inclusion For researchinvolving human pluripotent stemcells provide a detaileddescription of the stem cellsbeing used in the research

Healthy Caucasian females between 19-40 years of age Fitzpatrick skin type I II or III (see box 98A for Fitzpatrickskin type assessment)

53 Exclusion Criteria Exclusion Criteria Describewhich potential participants willbe excluded from participationand list the criteria for theirexclusion

The participants will be excluded if they have skin photosensitivity or taking medication that promotes photosensitivity of their skin Also participants that have been onvacation to a sunny destination since October 2017 or visittanning beds on a regular basis will be excluded becausethey have been exposed to UVB radiation

54 Recruitment Provide adetailed description of themethod of recruitment Includewhere applicable A) Who willcontact prospective participantsB) by what means this will bedone C) How prospectiveparticipants will be identified D)Ensure that any letters of initialcontact or other recruitmentmaterials are attached to thissubmission on Page 9

The recruitment will be done via social media withFacebook (UVBstudy page) The recruitment advertisementis included in the submission The researcher will contactprospective participants after they voluntarily contacted thestudy email address UVBstudyalumniubcca Initial contact will be through email conversation until thepotential participant expresses interest participating byemail Once the participant has signed the consent form astudy identifier will be assigned to the participant to protectthe individuals identity

55 Recruitment ofNormalControl Participants Describe how prospectivenormalcontrol participants will

Each participant will serve as her own control Allparticipants will be recruited the same way

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be identified contacted andrecruited if the method differsfrom the above56 Use of Records If existingrecords (eg health recordsclinical lists or otherrecordsdatabases) will be usedto IDENTIFY potentialparticipants or COLLECT DATAplease describe how permissionto access this information and tocollect and use this informationwill be obtained

No existing records will be used for this study

57 Summary of StudyProcedures

Participants will contact the study coordinator and will beinvited to participate by and email that will be sent alongwith the consent form A first meeting will be set upbetween the research coordinator and the participant at theSkin Care Center to explain the protocol and to signconsent forms Also four stool collection kits will be handedto the participant After signing the consent form theFitzpatrick skin type will be assessed with the hand of aquestionnaire about the sun exposure habits The participant is responsible to collect two stool samplesduring the week prior to the first light exposure and store itin her freezer at home On the Monday of the first NB-UVB exposure the researchcoordinator will confirm that a stool sample is collected bythe participant The participant will be referred to the lab atLife Labs to collect one blood sample (one tube of 15 mlapproximately one table spoon full) and will later go to TheSkin Care Centre at VGH where the participants will beassessed under supervision of dr Harvey Lui MD for theirfirst full body NB-UVB exposure The participants will wearspecialised goggles to protect the eyes from the UVB raysand wear broad spectrum sunscreen on face and hands toprotect these areas from the light The NB-UVB lightexposure will happen in a full body cabin like an uprighttanning bed and will take no longer than 5 minutes A timewill be scheduled for the next two sessions with theparticipants On Wednesday and Friday the participant willreceive a NB-UVB dose that is 10 higher than the fisrtvisit if tolerated well Description of blood collection procedure at Life Labs Ablood sample will be taken by first applying a tourniquet tothe upper arm The skin on the inner side of the elbow willbe sterilised and a small sterile needle will be inserted intothe vein Two blood collection tubes will then be attached tothe needle which will fill with blood When the tube is fullthe needle will be removed A plaster or small bandage will be applied to cover the site where the needle

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was removed Blood samples will be marked with their study identifiersand analysed in Life labs for of serum 25-hydroxy vitaminD3 according to Standards Council of Canadarsquos GoodLaboratory Practice (GLP) principles and Good ClinicalPractice (GCP) The participant is responsible to collect tw stool samplesthe week after the three NB-UVB light exposures and storeit in the freezer The research coordinator will contact theparticipant when and where to pick up the stool samples orparticipant can drop them off at their own convenience atthe Skin Care Centre during on Monday Wednesday andFriday nights The stool samples that are collected from the participantwill be stored in the BCCHR in a -80C freezer in a lockedlab until all samples from all participants are collectedOnce all stool samples are collected they will be send offto the Stintzi Lab at the University of Ottawa for 16S rRNAsequencing The results will be analysed and stored on theBCCHR password-secured computer

6 Participant Information and Consent Process - Clinical Study [View Form]

61 Time to Participate Howmuch time will a participant beasked to dedicate to the projectbeyond that needed for normalcare

The first visit to sign the consent form and do the Skin typeassessment will take approximately 20 minutes The visitfor the first UVB exposure will take approx 20 minutes toreview the exposure methods The next two visits will take approximately 10-12 minuteseach The visits for the blood draws will take about 30 minutesdepending on the amount of waiting time of the Life Labslocation The total time the participant will spend to this study will be2 hours minutes

62 Time to Participate ndashNormalControl Participants Ifapplicable how much time will anormalcontrol volunteer beasked to dedicate to the project

Each participant will be treated similarly

63 RisksHarms Describe whatis known about the risks(harms) of the proposedresearch

The exposure to NB-UVB light will turn the skin slightly pinkfor 1-2 days NB-UVB is ultraviolet radiation and couldcause long term effects after excessive exposure like skinageing and skin cancer The exposure from this study isequivalent to 5 min sun exposure during a summerrsquos dayper visit and is unlikely to have any long-term effects Short-term side effects may include skin redness skin drynesstriggering of a cold sore All of these effects are minor and

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will resolve usually within a week In rare cases the skinmight turn red and gives a sun burn-like sensation In thiscase the sensation will fade away over the next days Theparticipant should contact the researcher in this case Although minimal there is a 05 risk of bleeding from theneedle site If this occurs the subject can be given apressure bandage The risks of blood draw also includespain andor discomfort bruising fainting andor lightheaded sensation and the rare possibility of infection

64 Benefits Describe anypotential benefits to theparticipant that could arise fromhis or her participation in theproposed research

Exposure to NB-UVB will produce vitamin D in your skinthat helps against seasonal affective disorder (SAD) and isimportant for your general health

65 Reimbursement Describeany reimbursement for expenses(eg meals parkingmedications) orpaymentsincentivesgifts-in-kind(eg honoraria gifts prizescredits) to be offered to theparticipants Provide full detailsof the amounts paymentschedules and value of gifts-in-kind

There is a $750 budget for this study for the 30 testparticipants Each participant will be given a $25 gift-certificate when the stool samples are collected and theparticipant is done with the study requirements

66 Obtaining Consent SpecifyA) who will explain the consentform B) who will consentparticipants C) Include details ofwhere the consent will beobtained and under whatcircumstances and D) therelationship of the personobtaining consent andparticipant

Once the potential participants agree to participate to thestudy by email the consent form will be explained in personby the research coordinator The research coordinator willbe able to answer all questions about possible concernsand about the procedure The consent form will bediscussed in person with the participant in an office settingin the Skin Care Center Once the participants sign theconsent form they agree to be a part of the study Theparticipants will get the stool collection kits at that time andwill come back for the further procedures one week laterThe participant is free to withdraw from the study at anygiven time for the duration of the study The physicians at the Skin Care Centre will go through theprocedures with the participant and is able to answer anyquestions regarding the UVB exposure

67A WaiverAlteration ofConsent If you are asking for awaiver or an alteration of therequirement for participantinformed consent please justifythe waiver or alteration andexplain how the study meets allthe criteria on the right Pleaseclick Guidance Notes on rightand ensure that you address

There will be no waiver

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each criteria individually Includethe corresponding letter (A B CD E) before each answer67B Waiver of Consent inIndividual Medical EmergenciesIf you are asking for a waiver oran alteration of the requirementfor participant informed consentin individual medicalemergencies please justify thewaiver or alteration and explainhow the study meets all thecriteria on the right Please clickGuidance Notes on right andensure that you address eachcriteria individually Include thecorresponding letter (A B C DE) before each answer

NA

68 Time to Consent How longafter being provided with detailedinformationconsent form aboutthe study will the participanthave to decide whether or not toparticipate Provide yourrationale for the amount of timegiven

Once the participant contacts the study by email theconsent form will be sent to them by email to read throughbefore the first meeting The research coordinator willdiscuss the contents of the consent form with theparticipant one week prior to the UVB light exposureprotocol Thus participants will have 1-2 weeks to reviewthe consent form before making a decision aboutparticipation

69 Capacity to Consent Willevery participant have thecapacity to give fully informedconsent on hisher own behalfPlease click Select to completethe question and view furtherdetails

Will theparticipanthave thecapacityto givefullyinformedconsent

Details ofthe natureof theincapacity

If notwhowillconsentonhisherbehalf

If not willheshe beable to giveassent toparticipate

If Yesexplainhowassentwill besought

Yes [Details]

610 Renewal of ConsentDescribe any situation in whichthe renewal of consent for thisresearch might be appropriateand how this would take place

There are no plans for renewal of consent No furthercontact is required after obtaining the samples All samplesand data will be de-identified on collection and cannot betracked back to the subjects

611 Provisions for ConsentWhat provisions are planned forparticipants or those consentingon a participants behalf to havespecial assistance if neededduring the consent process (egconsent forms in Braille or inlanguages other than English)

Participants have to be able bodied to be able to participatein order to receive the UVB exposure Subjects with nounderstanding of the English language will not beapproached for involvement in the study unless a translatoris present who can converse in the first language of thesubject

612 Restrictions on DisclosureDescribe any restrictions

There are no restrictions on disclosure of information

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regarding the disclosure ofinformation to researchparticipants (during or at the endof the study) that the sponsorhas placed on investigatorsincluding those related to thepublication of results Alsoindicate any plans forcommunicating study results toparticipants7 Number of Participants and Study Drugs - Clinical Study [View Form]

71 Multi-Centre Studies 71A Is this a multi-centre study(involves centres outside ofthose applied for under thisApproval)

no

If known please list the othersites below

71B Is this study beingsubmitted for ethical approval toany other Research EthicsBoard

DescriptionNo

If yes please provide the nameof the REB(s) and if availablecontact information

72 Number of Participants 72A How many participants(including controls) will beenrolled in the entire study (iethe entire study world-wide)

30

72B How many participants(including controls) will beenrolled at institutions coveredby this Research EthicsApproval (ie only at theinstitutions covered by thisapproval)

30

72C Of these how many arecontrols 0

72D Please enter anyadditional comments

73 Drug approvals Enter thegeneric name of anyinvestigational drug(s) not yetapproved or any marketeddrug(s) used outside of itsapproved indication

NA

74 Marketed Drugs Enter thename of any marketed drug(s)

NA

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used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

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amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

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ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

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files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

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Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

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on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

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will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

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112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 5: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

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PI) If the research fundingapplicationaward associatedwith this study is not listed belowplease enter those details inquestion 2424 Research FundingApplicationAward Associatedwith the Study not listed inquestion 23 Please click Addto enter the details for theresearch fundingapplicationaward associatedwith this study that is not listed inquestion 23 When you pressAdd you can do a search foryour funding award by doing asearch in the Sponsor box - over7000 options are listed

UBC Number Title Sponsor

25A Is this a DHHS grant (Toview a list of DHHS fundingagencies click on add in 25Bbelow)

no

25B If yes please select theappropriate DHHS fundingagency from the selection boxand attach the grant to box 98of the application

DHHS Sponsor List Order Active

Attach DHHS Grant Applicationfor each sponsor listed above

26 Conflict of Interest Conflictsof Interest (COIs) can arisenaturally from an Investigatorrsquosengagement inside and outsidethe University and the mereexistence of a COI or theperception of a COI does notnecessarily imply wrongdoing onanyonersquos part Nonetheless realand perceived COI must berecognized disclosed andassessed This question asksInvestigators to disclose COIsthat may relate to the researchstudy that is the subject of theREB application Do thePrincipal Investigator Co-Investigators andor their relatedparties (defined at s812 UBCPolicy 97) have any personalinterest(s) that couldcompromise or reasonably beperceived to compromise the

no

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objective conduct of the researchor the integrity of the datagenerated by the studyPersonal interests may includebusiness commercial orfinancial interests as well aspersonal matters and careerinterests4 Study Type - Human Ethics Application [View Form]

41 UBC Research Ethics Board Indicate which UBC ResearchEthics Board you are applying toand the type of study you areapplying for

UBC Clinical Research Ethics Board

NA no

42A Institutions and Sites forStudy

Institution SiteVancouver Coastal Health(VCHRIVCHA)

Vancouver GeneralHospital

Childrens and Womens HealthCentre of BC (incl Sunny Hill)

BC Childrens Hospital(includes ResearchInstitute)

42B Please enter any otherlocations where the research willbe conducted under thisResearch Ethics Approval (egName of privately owned cliniccommunity centre schoolclassroom participants home inthe field - provide details)

The data will be collected in The Skin Care Center locatedat Vancouver General Hospital and data analysis will bedone by Life Labs and by the University of Ottawa incollaboration with professor Stintzi Data storage will bedone in the BCCHR institute

4 Clinical Study Review Type [View Form]

43 Relationship with otherproposals 43A If this proposalis closely linked to any otherproposalpreviouslysimultaneouslysubmitted enter the ResearchEthics Board number of thatproposal

No

43B If applicable pleasedescribe the relationshipbetween this proposal and thepreviouslysimultaneouslysubmitted proposal listed above

43C Have you received anyinformation or are you aware ofany rejection of this study by anyResearch Ethics Board If yesplease provide known details

no

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and attach any available relevantdocumentation in question 9743D Will biological materialsbe collected or analyzed by UBCresearchers or a UBC researchlab If yes please provide theUBC Biosafety Permit Number

No

43E Will radioisotopes beused in this project If yesprovide the UBC RadiationPermit Number

NA

44 Level of Risk Afterreviewing the minimal riskguidance notes and the criteriafor minimal risk does this studyqualify for minimal risk reviewNote that all studies which do notfall into the minimal risk categorywill undergo full board review

no

Peer Review If this researchproposal has received anyindependentscientificmethodological peerreview please include thenames of committees orindividuals involved in thereview State whether the peerreview process is ongoing orcompleted All above minimalrisk studies generally require apeer review 45A Externalpeer review details

NO

45B Internal (UBC or hospital)peer review details Yes dr Vincent Ho MD FRCPC FRCP completed

45C If this research proposalhas NOT received anyindependentscientificmethodological peerreview explain why no reviewhas taken place

NA

46 Multi-jurisdictional studies Please read and review theguidance note on the right priorto completing this question Isthis study a multi-jurisdictionalstudy that will also require reviewby one or more REB with whichthe University of BritishColumbia has a collaborativereview agreement (See theguidance to the right for detailsabout the harmonized process)

no

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Simon Fraser University University of Alberta Universityof Northern British Columbia Northern Health Authority University of Saskatchewan University of Victoria IslandHealth Authority Fraser HealthAuthority Interior HealthAuthority Note If submitting anamendment for an alreadyapproved study you mustrespond ldquoNordquo to this question)4 Clinical Study Review Type (Q 47 48) [View Form]

47A Creation of a Registry(Data or Tissue Bank) Doesthis study involve the creation ofa registry (data or tissue bank)for future use in other research[if no skip to 48]

no

47B Is the purpose of thisapplication exclusively to obtainapproval for the creation of aresearch database registry ortissue bank [Note if the creationof the database or registry ortissue repository is part of abigger project also included inthis application you mustanswer no below]

no

Clinical Chart Review 48A Isthis an application for researchrequiring access to clinical chartsOR data from registries ordatabases such as PopData BCor Pharmanet

no

48B Insert the date range ofthe chartsdata to be included inthis research (eg 7 September2005 ndash 6 September 2011)

48C Is this study exclusively aretrospective chart review wherethe only source of data will bemedical chartsrecords that arecurrently in existence (ie willpre-date the date of your initialethics approval)

48D Are you collecting andretaining personally identifiableinformation to be a part of thedata set

48E Is this a retrospective

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chart review study for whichparticipant consent will beobtained5 Summary of Study and Recruitment - Clinical Study [View Form]

51 Study Summary 51A Provide a short summary of theproject written in lay languagesuitable for non-scientific REBmembers DO NOT exceed 100words and do not cut and pastedirectly from the study protocol

This research will explore the potential effects of Narrow-Band Ultra Violet B (NB-UVB) radiation on the intestinalmicrobiota composition and confirm a regulatory skin-to-gutaxis during baseline conditions Changes in the intestinalmicrobiota composition caused by NB-UVB phototherapycould be beneficial for patients with chronicauto-inflammatory diseases like IBD by removing dangerousbacteria increasing beneficial bacteria and ultimatelymodulating immune responses

51B Summarize the researchproposal Purpose Hypothesis Justification ObjectivesResearch Design and StatisticalAnalysis

Purpose To explore the potential effects of Narrow-Band Ultra VioletB (NB-UVB) radiation on the intestinal microbiotacomposition in humans and confirm a regulatory skin-to-gutaxis during baseline conditions Hypothesis Humans exposed to UVB-NB light will show changes in theintestinal microbiota composition with selection of certainphyla of bacteria Justification To date there is no data that describes a biologicalresponse to UVB light in the body that affects the intestinalmicrobiota Changes in the intestinal microbiotacomposition caused by NB-UVB phototherapy could bebeneficial for patients with chronicauto-inflammatorydiseases like IBD by removing dangerous bacteriaincreasing beneficial bacteria and ultimately modulatingimmune responses Objectives 1 Establish if there is an skin regulatory response towardsNB-UVB light in humans 2 Examine what changes in the microbiota compositioncan be observed on bacterial phyla and class level 3 Determine if this research is worth pursuing in a largercohort Research design During the first visit the skin type will be assessed by usingthe Fitzpatrick skin type questionnaire Subsequently subjects will be exposed three times withinone week to full body NB-UVB light in The Skin CareCentre to a sub erythemic dose (cause slight redness of theskin but not burning) The exposures will happen during thewinter months to prevent UVB exposure from the sunduring daily activities to interfere with our observationsStool samples will be collected before the first exposure(2x) and after the last exposure (2x) to analyse the

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microbiota composition Also serum vitamin D (25-hydroxyvitamin D) will be measured before and after the UVBexposure as a marker of previous UVB exposure before theexperiment Subjects will be healthy Caucasian females between 19-40years of age with a Fitzpatrick skin type I II or III tominimise the variability in skin responses towards the UVB-NB light since fair skin colour is less adapted to absorb theUVB radiation than dark coloured skin The microbiota composition will be analysed with 16S rRNAIllumina sequencing and calculated for differentialabundance on phylum level Statistical analysis The statistical analysis will focus the personal microbiotacomposition variation after NB-UVB light exposure incomparison to before the UVB light exposure Because wecollect two samples before and two samples after the UVBexposures each individual can serve as her own internalcontrol

52 Inclusion Criteria InclusionCriteria Describe theparticipants being selected forthis study and list the criteria fortheir inclusion For researchinvolving human pluripotent stemcells provide a detaileddescription of the stem cellsbeing used in the research

Healthy Caucasian females between 19-40 years of age Fitzpatrick skin type I II or III (see box 98A for Fitzpatrickskin type assessment)

53 Exclusion Criteria Exclusion Criteria Describewhich potential participants willbe excluded from participationand list the criteria for theirexclusion

The participants will be excluded if they have skin photosensitivity or taking medication that promotes photosensitivity of their skin Also participants that have been onvacation to a sunny destination since October 2017 or visittanning beds on a regular basis will be excluded becausethey have been exposed to UVB radiation

54 Recruitment Provide adetailed description of themethod of recruitment Includewhere applicable A) Who willcontact prospective participantsB) by what means this will bedone C) How prospectiveparticipants will be identified D)Ensure that any letters of initialcontact or other recruitmentmaterials are attached to thissubmission on Page 9

The recruitment will be done via social media withFacebook (UVBstudy page) The recruitment advertisementis included in the submission The researcher will contactprospective participants after they voluntarily contacted thestudy email address UVBstudyalumniubcca Initial contact will be through email conversation until thepotential participant expresses interest participating byemail Once the participant has signed the consent form astudy identifier will be assigned to the participant to protectthe individuals identity

55 Recruitment ofNormalControl Participants Describe how prospectivenormalcontrol participants will

Each participant will serve as her own control Allparticipants will be recruited the same way

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be identified contacted andrecruited if the method differsfrom the above56 Use of Records If existingrecords (eg health recordsclinical lists or otherrecordsdatabases) will be usedto IDENTIFY potentialparticipants or COLLECT DATAplease describe how permissionto access this information and tocollect and use this informationwill be obtained

No existing records will be used for this study

57 Summary of StudyProcedures

Participants will contact the study coordinator and will beinvited to participate by and email that will be sent alongwith the consent form A first meeting will be set upbetween the research coordinator and the participant at theSkin Care Center to explain the protocol and to signconsent forms Also four stool collection kits will be handedto the participant After signing the consent form theFitzpatrick skin type will be assessed with the hand of aquestionnaire about the sun exposure habits The participant is responsible to collect two stool samplesduring the week prior to the first light exposure and store itin her freezer at home On the Monday of the first NB-UVB exposure the researchcoordinator will confirm that a stool sample is collected bythe participant The participant will be referred to the lab atLife Labs to collect one blood sample (one tube of 15 mlapproximately one table spoon full) and will later go to TheSkin Care Centre at VGH where the participants will beassessed under supervision of dr Harvey Lui MD for theirfirst full body NB-UVB exposure The participants will wearspecialised goggles to protect the eyes from the UVB raysand wear broad spectrum sunscreen on face and hands toprotect these areas from the light The NB-UVB lightexposure will happen in a full body cabin like an uprighttanning bed and will take no longer than 5 minutes A timewill be scheduled for the next two sessions with theparticipants On Wednesday and Friday the participant willreceive a NB-UVB dose that is 10 higher than the fisrtvisit if tolerated well Description of blood collection procedure at Life Labs Ablood sample will be taken by first applying a tourniquet tothe upper arm The skin on the inner side of the elbow willbe sterilised and a small sterile needle will be inserted intothe vein Two blood collection tubes will then be attached tothe needle which will fill with blood When the tube is fullthe needle will be removed A plaster or small bandage will be applied to cover the site where the needle

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was removed Blood samples will be marked with their study identifiersand analysed in Life labs for of serum 25-hydroxy vitaminD3 according to Standards Council of Canadarsquos GoodLaboratory Practice (GLP) principles and Good ClinicalPractice (GCP) The participant is responsible to collect tw stool samplesthe week after the three NB-UVB light exposures and storeit in the freezer The research coordinator will contact theparticipant when and where to pick up the stool samples orparticipant can drop them off at their own convenience atthe Skin Care Centre during on Monday Wednesday andFriday nights The stool samples that are collected from the participantwill be stored in the BCCHR in a -80C freezer in a lockedlab until all samples from all participants are collectedOnce all stool samples are collected they will be send offto the Stintzi Lab at the University of Ottawa for 16S rRNAsequencing The results will be analysed and stored on theBCCHR password-secured computer

6 Participant Information and Consent Process - Clinical Study [View Form]

61 Time to Participate Howmuch time will a participant beasked to dedicate to the projectbeyond that needed for normalcare

The first visit to sign the consent form and do the Skin typeassessment will take approximately 20 minutes The visitfor the first UVB exposure will take approx 20 minutes toreview the exposure methods The next two visits will take approximately 10-12 minuteseach The visits for the blood draws will take about 30 minutesdepending on the amount of waiting time of the Life Labslocation The total time the participant will spend to this study will be2 hours minutes

62 Time to Participate ndashNormalControl Participants Ifapplicable how much time will anormalcontrol volunteer beasked to dedicate to the project

Each participant will be treated similarly

63 RisksHarms Describe whatis known about the risks(harms) of the proposedresearch

The exposure to NB-UVB light will turn the skin slightly pinkfor 1-2 days NB-UVB is ultraviolet radiation and couldcause long term effects after excessive exposure like skinageing and skin cancer The exposure from this study isequivalent to 5 min sun exposure during a summerrsquos dayper visit and is unlikely to have any long-term effects Short-term side effects may include skin redness skin drynesstriggering of a cold sore All of these effects are minor and

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will resolve usually within a week In rare cases the skinmight turn red and gives a sun burn-like sensation In thiscase the sensation will fade away over the next days Theparticipant should contact the researcher in this case Although minimal there is a 05 risk of bleeding from theneedle site If this occurs the subject can be given apressure bandage The risks of blood draw also includespain andor discomfort bruising fainting andor lightheaded sensation and the rare possibility of infection

64 Benefits Describe anypotential benefits to theparticipant that could arise fromhis or her participation in theproposed research

Exposure to NB-UVB will produce vitamin D in your skinthat helps against seasonal affective disorder (SAD) and isimportant for your general health

65 Reimbursement Describeany reimbursement for expenses(eg meals parkingmedications) orpaymentsincentivesgifts-in-kind(eg honoraria gifts prizescredits) to be offered to theparticipants Provide full detailsof the amounts paymentschedules and value of gifts-in-kind

There is a $750 budget for this study for the 30 testparticipants Each participant will be given a $25 gift-certificate when the stool samples are collected and theparticipant is done with the study requirements

66 Obtaining Consent SpecifyA) who will explain the consentform B) who will consentparticipants C) Include details ofwhere the consent will beobtained and under whatcircumstances and D) therelationship of the personobtaining consent andparticipant

Once the potential participants agree to participate to thestudy by email the consent form will be explained in personby the research coordinator The research coordinator willbe able to answer all questions about possible concernsand about the procedure The consent form will bediscussed in person with the participant in an office settingin the Skin Care Center Once the participants sign theconsent form they agree to be a part of the study Theparticipants will get the stool collection kits at that time andwill come back for the further procedures one week laterThe participant is free to withdraw from the study at anygiven time for the duration of the study The physicians at the Skin Care Centre will go through theprocedures with the participant and is able to answer anyquestions regarding the UVB exposure

67A WaiverAlteration ofConsent If you are asking for awaiver or an alteration of therequirement for participantinformed consent please justifythe waiver or alteration andexplain how the study meets allthe criteria on the right Pleaseclick Guidance Notes on rightand ensure that you address

There will be no waiver

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each criteria individually Includethe corresponding letter (A B CD E) before each answer67B Waiver of Consent inIndividual Medical EmergenciesIf you are asking for a waiver oran alteration of the requirementfor participant informed consentin individual medicalemergencies please justify thewaiver or alteration and explainhow the study meets all thecriteria on the right Please clickGuidance Notes on right andensure that you address eachcriteria individually Include thecorresponding letter (A B C DE) before each answer

NA

68 Time to Consent How longafter being provided with detailedinformationconsent form aboutthe study will the participanthave to decide whether or not toparticipate Provide yourrationale for the amount of timegiven

Once the participant contacts the study by email theconsent form will be sent to them by email to read throughbefore the first meeting The research coordinator willdiscuss the contents of the consent form with theparticipant one week prior to the UVB light exposureprotocol Thus participants will have 1-2 weeks to reviewthe consent form before making a decision aboutparticipation

69 Capacity to Consent Willevery participant have thecapacity to give fully informedconsent on hisher own behalfPlease click Select to completethe question and view furtherdetails

Will theparticipanthave thecapacityto givefullyinformedconsent

Details ofthe natureof theincapacity

If notwhowillconsentonhisherbehalf

If not willheshe beable to giveassent toparticipate

If Yesexplainhowassentwill besought

Yes [Details]

610 Renewal of ConsentDescribe any situation in whichthe renewal of consent for thisresearch might be appropriateand how this would take place

There are no plans for renewal of consent No furthercontact is required after obtaining the samples All samplesand data will be de-identified on collection and cannot betracked back to the subjects

611 Provisions for ConsentWhat provisions are planned forparticipants or those consentingon a participants behalf to havespecial assistance if neededduring the consent process (egconsent forms in Braille or inlanguages other than English)

Participants have to be able bodied to be able to participatein order to receive the UVB exposure Subjects with nounderstanding of the English language will not beapproached for involvement in the study unless a translatoris present who can converse in the first language of thesubject

612 Restrictions on DisclosureDescribe any restrictions

There are no restrictions on disclosure of information

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regarding the disclosure ofinformation to researchparticipants (during or at the endof the study) that the sponsorhas placed on investigatorsincluding those related to thepublication of results Alsoindicate any plans forcommunicating study results toparticipants7 Number of Participants and Study Drugs - Clinical Study [View Form]

71 Multi-Centre Studies 71A Is this a multi-centre study(involves centres outside ofthose applied for under thisApproval)

no

If known please list the othersites below

71B Is this study beingsubmitted for ethical approval toany other Research EthicsBoard

DescriptionNo

If yes please provide the nameof the REB(s) and if availablecontact information

72 Number of Participants 72A How many participants(including controls) will beenrolled in the entire study (iethe entire study world-wide)

30

72B How many participants(including controls) will beenrolled at institutions coveredby this Research EthicsApproval (ie only at theinstitutions covered by thisapproval)

30

72C Of these how many arecontrols 0

72D Please enter anyadditional comments

73 Drug approvals Enter thegeneric name of anyinvestigational drug(s) not yetapproved or any marketeddrug(s) used outside of itsapproved indication

NA

74 Marketed Drugs Enter thename of any marketed drug(s)

NA

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used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

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amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

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ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

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files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

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Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

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on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

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will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

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112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 6: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

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objective conduct of the researchor the integrity of the datagenerated by the studyPersonal interests may includebusiness commercial orfinancial interests as well aspersonal matters and careerinterests4 Study Type - Human Ethics Application [View Form]

41 UBC Research Ethics Board Indicate which UBC ResearchEthics Board you are applying toand the type of study you areapplying for

UBC Clinical Research Ethics Board

NA no

42A Institutions and Sites forStudy

Institution SiteVancouver Coastal Health(VCHRIVCHA)

Vancouver GeneralHospital

Childrens and Womens HealthCentre of BC (incl Sunny Hill)

BC Childrens Hospital(includes ResearchInstitute)

42B Please enter any otherlocations where the research willbe conducted under thisResearch Ethics Approval (egName of privately owned cliniccommunity centre schoolclassroom participants home inthe field - provide details)

The data will be collected in The Skin Care Center locatedat Vancouver General Hospital and data analysis will bedone by Life Labs and by the University of Ottawa incollaboration with professor Stintzi Data storage will bedone in the BCCHR institute

4 Clinical Study Review Type [View Form]

43 Relationship with otherproposals 43A If this proposalis closely linked to any otherproposalpreviouslysimultaneouslysubmitted enter the ResearchEthics Board number of thatproposal

No

43B If applicable pleasedescribe the relationshipbetween this proposal and thepreviouslysimultaneouslysubmitted proposal listed above

43C Have you received anyinformation or are you aware ofany rejection of this study by anyResearch Ethics Board If yesplease provide known details

no

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and attach any available relevantdocumentation in question 9743D Will biological materialsbe collected or analyzed by UBCresearchers or a UBC researchlab If yes please provide theUBC Biosafety Permit Number

No

43E Will radioisotopes beused in this project If yesprovide the UBC RadiationPermit Number

NA

44 Level of Risk Afterreviewing the minimal riskguidance notes and the criteriafor minimal risk does this studyqualify for minimal risk reviewNote that all studies which do notfall into the minimal risk categorywill undergo full board review

no

Peer Review If this researchproposal has received anyindependentscientificmethodological peerreview please include thenames of committees orindividuals involved in thereview State whether the peerreview process is ongoing orcompleted All above minimalrisk studies generally require apeer review 45A Externalpeer review details

NO

45B Internal (UBC or hospital)peer review details Yes dr Vincent Ho MD FRCPC FRCP completed

45C If this research proposalhas NOT received anyindependentscientificmethodological peerreview explain why no reviewhas taken place

NA

46 Multi-jurisdictional studies Please read and review theguidance note on the right priorto completing this question Isthis study a multi-jurisdictionalstudy that will also require reviewby one or more REB with whichthe University of BritishColumbia has a collaborativereview agreement (See theguidance to the right for detailsabout the harmonized process)

no

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Simon Fraser University University of Alberta Universityof Northern British Columbia Northern Health Authority University of Saskatchewan University of Victoria IslandHealth Authority Fraser HealthAuthority Interior HealthAuthority Note If submitting anamendment for an alreadyapproved study you mustrespond ldquoNordquo to this question)4 Clinical Study Review Type (Q 47 48) [View Form]

47A Creation of a Registry(Data or Tissue Bank) Doesthis study involve the creation ofa registry (data or tissue bank)for future use in other research[if no skip to 48]

no

47B Is the purpose of thisapplication exclusively to obtainapproval for the creation of aresearch database registry ortissue bank [Note if the creationof the database or registry ortissue repository is part of abigger project also included inthis application you mustanswer no below]

no

Clinical Chart Review 48A Isthis an application for researchrequiring access to clinical chartsOR data from registries ordatabases such as PopData BCor Pharmanet

no

48B Insert the date range ofthe chartsdata to be included inthis research (eg 7 September2005 ndash 6 September 2011)

48C Is this study exclusively aretrospective chart review wherethe only source of data will bemedical chartsrecords that arecurrently in existence (ie willpre-date the date of your initialethics approval)

48D Are you collecting andretaining personally identifiableinformation to be a part of thedata set

48E Is this a retrospective

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chart review study for whichparticipant consent will beobtained5 Summary of Study and Recruitment - Clinical Study [View Form]

51 Study Summary 51A Provide a short summary of theproject written in lay languagesuitable for non-scientific REBmembers DO NOT exceed 100words and do not cut and pastedirectly from the study protocol

This research will explore the potential effects of Narrow-Band Ultra Violet B (NB-UVB) radiation on the intestinalmicrobiota composition and confirm a regulatory skin-to-gutaxis during baseline conditions Changes in the intestinalmicrobiota composition caused by NB-UVB phototherapycould be beneficial for patients with chronicauto-inflammatory diseases like IBD by removing dangerousbacteria increasing beneficial bacteria and ultimatelymodulating immune responses

51B Summarize the researchproposal Purpose Hypothesis Justification ObjectivesResearch Design and StatisticalAnalysis

Purpose To explore the potential effects of Narrow-Band Ultra VioletB (NB-UVB) radiation on the intestinal microbiotacomposition in humans and confirm a regulatory skin-to-gutaxis during baseline conditions Hypothesis Humans exposed to UVB-NB light will show changes in theintestinal microbiota composition with selection of certainphyla of bacteria Justification To date there is no data that describes a biologicalresponse to UVB light in the body that affects the intestinalmicrobiota Changes in the intestinal microbiotacomposition caused by NB-UVB phototherapy could bebeneficial for patients with chronicauto-inflammatorydiseases like IBD by removing dangerous bacteriaincreasing beneficial bacteria and ultimately modulatingimmune responses Objectives 1 Establish if there is an skin regulatory response towardsNB-UVB light in humans 2 Examine what changes in the microbiota compositioncan be observed on bacterial phyla and class level 3 Determine if this research is worth pursuing in a largercohort Research design During the first visit the skin type will be assessed by usingthe Fitzpatrick skin type questionnaire Subsequently subjects will be exposed three times withinone week to full body NB-UVB light in The Skin CareCentre to a sub erythemic dose (cause slight redness of theskin but not burning) The exposures will happen during thewinter months to prevent UVB exposure from the sunduring daily activities to interfere with our observationsStool samples will be collected before the first exposure(2x) and after the last exposure (2x) to analyse the

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microbiota composition Also serum vitamin D (25-hydroxyvitamin D) will be measured before and after the UVBexposure as a marker of previous UVB exposure before theexperiment Subjects will be healthy Caucasian females between 19-40years of age with a Fitzpatrick skin type I II or III tominimise the variability in skin responses towards the UVB-NB light since fair skin colour is less adapted to absorb theUVB radiation than dark coloured skin The microbiota composition will be analysed with 16S rRNAIllumina sequencing and calculated for differentialabundance on phylum level Statistical analysis The statistical analysis will focus the personal microbiotacomposition variation after NB-UVB light exposure incomparison to before the UVB light exposure Because wecollect two samples before and two samples after the UVBexposures each individual can serve as her own internalcontrol

52 Inclusion Criteria InclusionCriteria Describe theparticipants being selected forthis study and list the criteria fortheir inclusion For researchinvolving human pluripotent stemcells provide a detaileddescription of the stem cellsbeing used in the research

Healthy Caucasian females between 19-40 years of age Fitzpatrick skin type I II or III (see box 98A for Fitzpatrickskin type assessment)

53 Exclusion Criteria Exclusion Criteria Describewhich potential participants willbe excluded from participationand list the criteria for theirexclusion

The participants will be excluded if they have skin photosensitivity or taking medication that promotes photosensitivity of their skin Also participants that have been onvacation to a sunny destination since October 2017 or visittanning beds on a regular basis will be excluded becausethey have been exposed to UVB radiation

54 Recruitment Provide adetailed description of themethod of recruitment Includewhere applicable A) Who willcontact prospective participantsB) by what means this will bedone C) How prospectiveparticipants will be identified D)Ensure that any letters of initialcontact or other recruitmentmaterials are attached to thissubmission on Page 9

The recruitment will be done via social media withFacebook (UVBstudy page) The recruitment advertisementis included in the submission The researcher will contactprospective participants after they voluntarily contacted thestudy email address UVBstudyalumniubcca Initial contact will be through email conversation until thepotential participant expresses interest participating byemail Once the participant has signed the consent form astudy identifier will be assigned to the participant to protectthe individuals identity

55 Recruitment ofNormalControl Participants Describe how prospectivenormalcontrol participants will

Each participant will serve as her own control Allparticipants will be recruited the same way

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be identified contacted andrecruited if the method differsfrom the above56 Use of Records If existingrecords (eg health recordsclinical lists or otherrecordsdatabases) will be usedto IDENTIFY potentialparticipants or COLLECT DATAplease describe how permissionto access this information and tocollect and use this informationwill be obtained

No existing records will be used for this study

57 Summary of StudyProcedures

Participants will contact the study coordinator and will beinvited to participate by and email that will be sent alongwith the consent form A first meeting will be set upbetween the research coordinator and the participant at theSkin Care Center to explain the protocol and to signconsent forms Also four stool collection kits will be handedto the participant After signing the consent form theFitzpatrick skin type will be assessed with the hand of aquestionnaire about the sun exposure habits The participant is responsible to collect two stool samplesduring the week prior to the first light exposure and store itin her freezer at home On the Monday of the first NB-UVB exposure the researchcoordinator will confirm that a stool sample is collected bythe participant The participant will be referred to the lab atLife Labs to collect one blood sample (one tube of 15 mlapproximately one table spoon full) and will later go to TheSkin Care Centre at VGH where the participants will beassessed under supervision of dr Harvey Lui MD for theirfirst full body NB-UVB exposure The participants will wearspecialised goggles to protect the eyes from the UVB raysand wear broad spectrum sunscreen on face and hands toprotect these areas from the light The NB-UVB lightexposure will happen in a full body cabin like an uprighttanning bed and will take no longer than 5 minutes A timewill be scheduled for the next two sessions with theparticipants On Wednesday and Friday the participant willreceive a NB-UVB dose that is 10 higher than the fisrtvisit if tolerated well Description of blood collection procedure at Life Labs Ablood sample will be taken by first applying a tourniquet tothe upper arm The skin on the inner side of the elbow willbe sterilised and a small sterile needle will be inserted intothe vein Two blood collection tubes will then be attached tothe needle which will fill with blood When the tube is fullthe needle will be removed A plaster or small bandage will be applied to cover the site where the needle

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was removed Blood samples will be marked with their study identifiersand analysed in Life labs for of serum 25-hydroxy vitaminD3 according to Standards Council of Canadarsquos GoodLaboratory Practice (GLP) principles and Good ClinicalPractice (GCP) The participant is responsible to collect tw stool samplesthe week after the three NB-UVB light exposures and storeit in the freezer The research coordinator will contact theparticipant when and where to pick up the stool samples orparticipant can drop them off at their own convenience atthe Skin Care Centre during on Monday Wednesday andFriday nights The stool samples that are collected from the participantwill be stored in the BCCHR in a -80C freezer in a lockedlab until all samples from all participants are collectedOnce all stool samples are collected they will be send offto the Stintzi Lab at the University of Ottawa for 16S rRNAsequencing The results will be analysed and stored on theBCCHR password-secured computer

6 Participant Information and Consent Process - Clinical Study [View Form]

61 Time to Participate Howmuch time will a participant beasked to dedicate to the projectbeyond that needed for normalcare

The first visit to sign the consent form and do the Skin typeassessment will take approximately 20 minutes The visitfor the first UVB exposure will take approx 20 minutes toreview the exposure methods The next two visits will take approximately 10-12 minuteseach The visits for the blood draws will take about 30 minutesdepending on the amount of waiting time of the Life Labslocation The total time the participant will spend to this study will be2 hours minutes

62 Time to Participate ndashNormalControl Participants Ifapplicable how much time will anormalcontrol volunteer beasked to dedicate to the project

Each participant will be treated similarly

63 RisksHarms Describe whatis known about the risks(harms) of the proposedresearch

The exposure to NB-UVB light will turn the skin slightly pinkfor 1-2 days NB-UVB is ultraviolet radiation and couldcause long term effects after excessive exposure like skinageing and skin cancer The exposure from this study isequivalent to 5 min sun exposure during a summerrsquos dayper visit and is unlikely to have any long-term effects Short-term side effects may include skin redness skin drynesstriggering of a cold sore All of these effects are minor and

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will resolve usually within a week In rare cases the skinmight turn red and gives a sun burn-like sensation In thiscase the sensation will fade away over the next days Theparticipant should contact the researcher in this case Although minimal there is a 05 risk of bleeding from theneedle site If this occurs the subject can be given apressure bandage The risks of blood draw also includespain andor discomfort bruising fainting andor lightheaded sensation and the rare possibility of infection

64 Benefits Describe anypotential benefits to theparticipant that could arise fromhis or her participation in theproposed research

Exposure to NB-UVB will produce vitamin D in your skinthat helps against seasonal affective disorder (SAD) and isimportant for your general health

65 Reimbursement Describeany reimbursement for expenses(eg meals parkingmedications) orpaymentsincentivesgifts-in-kind(eg honoraria gifts prizescredits) to be offered to theparticipants Provide full detailsof the amounts paymentschedules and value of gifts-in-kind

There is a $750 budget for this study for the 30 testparticipants Each participant will be given a $25 gift-certificate when the stool samples are collected and theparticipant is done with the study requirements

66 Obtaining Consent SpecifyA) who will explain the consentform B) who will consentparticipants C) Include details ofwhere the consent will beobtained and under whatcircumstances and D) therelationship of the personobtaining consent andparticipant

Once the potential participants agree to participate to thestudy by email the consent form will be explained in personby the research coordinator The research coordinator willbe able to answer all questions about possible concernsand about the procedure The consent form will bediscussed in person with the participant in an office settingin the Skin Care Center Once the participants sign theconsent form they agree to be a part of the study Theparticipants will get the stool collection kits at that time andwill come back for the further procedures one week laterThe participant is free to withdraw from the study at anygiven time for the duration of the study The physicians at the Skin Care Centre will go through theprocedures with the participant and is able to answer anyquestions regarding the UVB exposure

67A WaiverAlteration ofConsent If you are asking for awaiver or an alteration of therequirement for participantinformed consent please justifythe waiver or alteration andexplain how the study meets allthe criteria on the right Pleaseclick Guidance Notes on rightand ensure that you address

There will be no waiver

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each criteria individually Includethe corresponding letter (A B CD E) before each answer67B Waiver of Consent inIndividual Medical EmergenciesIf you are asking for a waiver oran alteration of the requirementfor participant informed consentin individual medicalemergencies please justify thewaiver or alteration and explainhow the study meets all thecriteria on the right Please clickGuidance Notes on right andensure that you address eachcriteria individually Include thecorresponding letter (A B C DE) before each answer

NA

68 Time to Consent How longafter being provided with detailedinformationconsent form aboutthe study will the participanthave to decide whether or not toparticipate Provide yourrationale for the amount of timegiven

Once the participant contacts the study by email theconsent form will be sent to them by email to read throughbefore the first meeting The research coordinator willdiscuss the contents of the consent form with theparticipant one week prior to the UVB light exposureprotocol Thus participants will have 1-2 weeks to reviewthe consent form before making a decision aboutparticipation

69 Capacity to Consent Willevery participant have thecapacity to give fully informedconsent on hisher own behalfPlease click Select to completethe question and view furtherdetails

Will theparticipanthave thecapacityto givefullyinformedconsent

Details ofthe natureof theincapacity

If notwhowillconsentonhisherbehalf

If not willheshe beable to giveassent toparticipate

If Yesexplainhowassentwill besought

Yes [Details]

610 Renewal of ConsentDescribe any situation in whichthe renewal of consent for thisresearch might be appropriateand how this would take place

There are no plans for renewal of consent No furthercontact is required after obtaining the samples All samplesand data will be de-identified on collection and cannot betracked back to the subjects

611 Provisions for ConsentWhat provisions are planned forparticipants or those consentingon a participants behalf to havespecial assistance if neededduring the consent process (egconsent forms in Braille or inlanguages other than English)

Participants have to be able bodied to be able to participatein order to receive the UVB exposure Subjects with nounderstanding of the English language will not beapproached for involvement in the study unless a translatoris present who can converse in the first language of thesubject

612 Restrictions on DisclosureDescribe any restrictions

There are no restrictions on disclosure of information

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regarding the disclosure ofinformation to researchparticipants (during or at the endof the study) that the sponsorhas placed on investigatorsincluding those related to thepublication of results Alsoindicate any plans forcommunicating study results toparticipants7 Number of Participants and Study Drugs - Clinical Study [View Form]

71 Multi-Centre Studies 71A Is this a multi-centre study(involves centres outside ofthose applied for under thisApproval)

no

If known please list the othersites below

71B Is this study beingsubmitted for ethical approval toany other Research EthicsBoard

DescriptionNo

If yes please provide the nameof the REB(s) and if availablecontact information

72 Number of Participants 72A How many participants(including controls) will beenrolled in the entire study (iethe entire study world-wide)

30

72B How many participants(including controls) will beenrolled at institutions coveredby this Research EthicsApproval (ie only at theinstitutions covered by thisapproval)

30

72C Of these how many arecontrols 0

72D Please enter anyadditional comments

73 Drug approvals Enter thegeneric name of anyinvestigational drug(s) not yetapproved or any marketeddrug(s) used outside of itsapproved indication

NA

74 Marketed Drugs Enter thename of any marketed drug(s)

NA

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used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

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amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

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ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

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files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

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Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

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on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

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will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

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112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 7: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

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and attach any available relevantdocumentation in question 9743D Will biological materialsbe collected or analyzed by UBCresearchers or a UBC researchlab If yes please provide theUBC Biosafety Permit Number

No

43E Will radioisotopes beused in this project If yesprovide the UBC RadiationPermit Number

NA

44 Level of Risk Afterreviewing the minimal riskguidance notes and the criteriafor minimal risk does this studyqualify for minimal risk reviewNote that all studies which do notfall into the minimal risk categorywill undergo full board review

no

Peer Review If this researchproposal has received anyindependentscientificmethodological peerreview please include thenames of committees orindividuals involved in thereview State whether the peerreview process is ongoing orcompleted All above minimalrisk studies generally require apeer review 45A Externalpeer review details

NO

45B Internal (UBC or hospital)peer review details Yes dr Vincent Ho MD FRCPC FRCP completed

45C If this research proposalhas NOT received anyindependentscientificmethodological peerreview explain why no reviewhas taken place

NA

46 Multi-jurisdictional studies Please read and review theguidance note on the right priorto completing this question Isthis study a multi-jurisdictionalstudy that will also require reviewby one or more REB with whichthe University of BritishColumbia has a collaborativereview agreement (See theguidance to the right for detailsabout the harmonized process)

no

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Simon Fraser University University of Alberta Universityof Northern British Columbia Northern Health Authority University of Saskatchewan University of Victoria IslandHealth Authority Fraser HealthAuthority Interior HealthAuthority Note If submitting anamendment for an alreadyapproved study you mustrespond ldquoNordquo to this question)4 Clinical Study Review Type (Q 47 48) [View Form]

47A Creation of a Registry(Data or Tissue Bank) Doesthis study involve the creation ofa registry (data or tissue bank)for future use in other research[if no skip to 48]

no

47B Is the purpose of thisapplication exclusively to obtainapproval for the creation of aresearch database registry ortissue bank [Note if the creationof the database or registry ortissue repository is part of abigger project also included inthis application you mustanswer no below]

no

Clinical Chart Review 48A Isthis an application for researchrequiring access to clinical chartsOR data from registries ordatabases such as PopData BCor Pharmanet

no

48B Insert the date range ofthe chartsdata to be included inthis research (eg 7 September2005 ndash 6 September 2011)

48C Is this study exclusively aretrospective chart review wherethe only source of data will bemedical chartsrecords that arecurrently in existence (ie willpre-date the date of your initialethics approval)

48D Are you collecting andretaining personally identifiableinformation to be a part of thedata set

48E Is this a retrospective

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chart review study for whichparticipant consent will beobtained5 Summary of Study and Recruitment - Clinical Study [View Form]

51 Study Summary 51A Provide a short summary of theproject written in lay languagesuitable for non-scientific REBmembers DO NOT exceed 100words and do not cut and pastedirectly from the study protocol

This research will explore the potential effects of Narrow-Band Ultra Violet B (NB-UVB) radiation on the intestinalmicrobiota composition and confirm a regulatory skin-to-gutaxis during baseline conditions Changes in the intestinalmicrobiota composition caused by NB-UVB phototherapycould be beneficial for patients with chronicauto-inflammatory diseases like IBD by removing dangerousbacteria increasing beneficial bacteria and ultimatelymodulating immune responses

51B Summarize the researchproposal Purpose Hypothesis Justification ObjectivesResearch Design and StatisticalAnalysis

Purpose To explore the potential effects of Narrow-Band Ultra VioletB (NB-UVB) radiation on the intestinal microbiotacomposition in humans and confirm a regulatory skin-to-gutaxis during baseline conditions Hypothesis Humans exposed to UVB-NB light will show changes in theintestinal microbiota composition with selection of certainphyla of bacteria Justification To date there is no data that describes a biologicalresponse to UVB light in the body that affects the intestinalmicrobiota Changes in the intestinal microbiotacomposition caused by NB-UVB phototherapy could bebeneficial for patients with chronicauto-inflammatorydiseases like IBD by removing dangerous bacteriaincreasing beneficial bacteria and ultimately modulatingimmune responses Objectives 1 Establish if there is an skin regulatory response towardsNB-UVB light in humans 2 Examine what changes in the microbiota compositioncan be observed on bacterial phyla and class level 3 Determine if this research is worth pursuing in a largercohort Research design During the first visit the skin type will be assessed by usingthe Fitzpatrick skin type questionnaire Subsequently subjects will be exposed three times withinone week to full body NB-UVB light in The Skin CareCentre to a sub erythemic dose (cause slight redness of theskin but not burning) The exposures will happen during thewinter months to prevent UVB exposure from the sunduring daily activities to interfere with our observationsStool samples will be collected before the first exposure(2x) and after the last exposure (2x) to analyse the

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microbiota composition Also serum vitamin D (25-hydroxyvitamin D) will be measured before and after the UVBexposure as a marker of previous UVB exposure before theexperiment Subjects will be healthy Caucasian females between 19-40years of age with a Fitzpatrick skin type I II or III tominimise the variability in skin responses towards the UVB-NB light since fair skin colour is less adapted to absorb theUVB radiation than dark coloured skin The microbiota composition will be analysed with 16S rRNAIllumina sequencing and calculated for differentialabundance on phylum level Statistical analysis The statistical analysis will focus the personal microbiotacomposition variation after NB-UVB light exposure incomparison to before the UVB light exposure Because wecollect two samples before and two samples after the UVBexposures each individual can serve as her own internalcontrol

52 Inclusion Criteria InclusionCriteria Describe theparticipants being selected forthis study and list the criteria fortheir inclusion For researchinvolving human pluripotent stemcells provide a detaileddescription of the stem cellsbeing used in the research

Healthy Caucasian females between 19-40 years of age Fitzpatrick skin type I II or III (see box 98A for Fitzpatrickskin type assessment)

53 Exclusion Criteria Exclusion Criteria Describewhich potential participants willbe excluded from participationand list the criteria for theirexclusion

The participants will be excluded if they have skin photosensitivity or taking medication that promotes photosensitivity of their skin Also participants that have been onvacation to a sunny destination since October 2017 or visittanning beds on a regular basis will be excluded becausethey have been exposed to UVB radiation

54 Recruitment Provide adetailed description of themethod of recruitment Includewhere applicable A) Who willcontact prospective participantsB) by what means this will bedone C) How prospectiveparticipants will be identified D)Ensure that any letters of initialcontact or other recruitmentmaterials are attached to thissubmission on Page 9

The recruitment will be done via social media withFacebook (UVBstudy page) The recruitment advertisementis included in the submission The researcher will contactprospective participants after they voluntarily contacted thestudy email address UVBstudyalumniubcca Initial contact will be through email conversation until thepotential participant expresses interest participating byemail Once the participant has signed the consent form astudy identifier will be assigned to the participant to protectthe individuals identity

55 Recruitment ofNormalControl Participants Describe how prospectivenormalcontrol participants will

Each participant will serve as her own control Allparticipants will be recruited the same way

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be identified contacted andrecruited if the method differsfrom the above56 Use of Records If existingrecords (eg health recordsclinical lists or otherrecordsdatabases) will be usedto IDENTIFY potentialparticipants or COLLECT DATAplease describe how permissionto access this information and tocollect and use this informationwill be obtained

No existing records will be used for this study

57 Summary of StudyProcedures

Participants will contact the study coordinator and will beinvited to participate by and email that will be sent alongwith the consent form A first meeting will be set upbetween the research coordinator and the participant at theSkin Care Center to explain the protocol and to signconsent forms Also four stool collection kits will be handedto the participant After signing the consent form theFitzpatrick skin type will be assessed with the hand of aquestionnaire about the sun exposure habits The participant is responsible to collect two stool samplesduring the week prior to the first light exposure and store itin her freezer at home On the Monday of the first NB-UVB exposure the researchcoordinator will confirm that a stool sample is collected bythe participant The participant will be referred to the lab atLife Labs to collect one blood sample (one tube of 15 mlapproximately one table spoon full) and will later go to TheSkin Care Centre at VGH where the participants will beassessed under supervision of dr Harvey Lui MD for theirfirst full body NB-UVB exposure The participants will wearspecialised goggles to protect the eyes from the UVB raysand wear broad spectrum sunscreen on face and hands toprotect these areas from the light The NB-UVB lightexposure will happen in a full body cabin like an uprighttanning bed and will take no longer than 5 minutes A timewill be scheduled for the next two sessions with theparticipants On Wednesday and Friday the participant willreceive a NB-UVB dose that is 10 higher than the fisrtvisit if tolerated well Description of blood collection procedure at Life Labs Ablood sample will be taken by first applying a tourniquet tothe upper arm The skin on the inner side of the elbow willbe sterilised and a small sterile needle will be inserted intothe vein Two blood collection tubes will then be attached tothe needle which will fill with blood When the tube is fullthe needle will be removed A plaster or small bandage will be applied to cover the site where the needle

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was removed Blood samples will be marked with their study identifiersand analysed in Life labs for of serum 25-hydroxy vitaminD3 according to Standards Council of Canadarsquos GoodLaboratory Practice (GLP) principles and Good ClinicalPractice (GCP) The participant is responsible to collect tw stool samplesthe week after the three NB-UVB light exposures and storeit in the freezer The research coordinator will contact theparticipant when and where to pick up the stool samples orparticipant can drop them off at their own convenience atthe Skin Care Centre during on Monday Wednesday andFriday nights The stool samples that are collected from the participantwill be stored in the BCCHR in a -80C freezer in a lockedlab until all samples from all participants are collectedOnce all stool samples are collected they will be send offto the Stintzi Lab at the University of Ottawa for 16S rRNAsequencing The results will be analysed and stored on theBCCHR password-secured computer

6 Participant Information and Consent Process - Clinical Study [View Form]

61 Time to Participate Howmuch time will a participant beasked to dedicate to the projectbeyond that needed for normalcare

The first visit to sign the consent form and do the Skin typeassessment will take approximately 20 minutes The visitfor the first UVB exposure will take approx 20 minutes toreview the exposure methods The next two visits will take approximately 10-12 minuteseach The visits for the blood draws will take about 30 minutesdepending on the amount of waiting time of the Life Labslocation The total time the participant will spend to this study will be2 hours minutes

62 Time to Participate ndashNormalControl Participants Ifapplicable how much time will anormalcontrol volunteer beasked to dedicate to the project

Each participant will be treated similarly

63 RisksHarms Describe whatis known about the risks(harms) of the proposedresearch

The exposure to NB-UVB light will turn the skin slightly pinkfor 1-2 days NB-UVB is ultraviolet radiation and couldcause long term effects after excessive exposure like skinageing and skin cancer The exposure from this study isequivalent to 5 min sun exposure during a summerrsquos dayper visit and is unlikely to have any long-term effects Short-term side effects may include skin redness skin drynesstriggering of a cold sore All of these effects are minor and

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will resolve usually within a week In rare cases the skinmight turn red and gives a sun burn-like sensation In thiscase the sensation will fade away over the next days Theparticipant should contact the researcher in this case Although minimal there is a 05 risk of bleeding from theneedle site If this occurs the subject can be given apressure bandage The risks of blood draw also includespain andor discomfort bruising fainting andor lightheaded sensation and the rare possibility of infection

64 Benefits Describe anypotential benefits to theparticipant that could arise fromhis or her participation in theproposed research

Exposure to NB-UVB will produce vitamin D in your skinthat helps against seasonal affective disorder (SAD) and isimportant for your general health

65 Reimbursement Describeany reimbursement for expenses(eg meals parkingmedications) orpaymentsincentivesgifts-in-kind(eg honoraria gifts prizescredits) to be offered to theparticipants Provide full detailsof the amounts paymentschedules and value of gifts-in-kind

There is a $750 budget for this study for the 30 testparticipants Each participant will be given a $25 gift-certificate when the stool samples are collected and theparticipant is done with the study requirements

66 Obtaining Consent SpecifyA) who will explain the consentform B) who will consentparticipants C) Include details ofwhere the consent will beobtained and under whatcircumstances and D) therelationship of the personobtaining consent andparticipant

Once the potential participants agree to participate to thestudy by email the consent form will be explained in personby the research coordinator The research coordinator willbe able to answer all questions about possible concernsand about the procedure The consent form will bediscussed in person with the participant in an office settingin the Skin Care Center Once the participants sign theconsent form they agree to be a part of the study Theparticipants will get the stool collection kits at that time andwill come back for the further procedures one week laterThe participant is free to withdraw from the study at anygiven time for the duration of the study The physicians at the Skin Care Centre will go through theprocedures with the participant and is able to answer anyquestions regarding the UVB exposure

67A WaiverAlteration ofConsent If you are asking for awaiver or an alteration of therequirement for participantinformed consent please justifythe waiver or alteration andexplain how the study meets allthe criteria on the right Pleaseclick Guidance Notes on rightand ensure that you address

There will be no waiver

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each criteria individually Includethe corresponding letter (A B CD E) before each answer67B Waiver of Consent inIndividual Medical EmergenciesIf you are asking for a waiver oran alteration of the requirementfor participant informed consentin individual medicalemergencies please justify thewaiver or alteration and explainhow the study meets all thecriteria on the right Please clickGuidance Notes on right andensure that you address eachcriteria individually Include thecorresponding letter (A B C DE) before each answer

NA

68 Time to Consent How longafter being provided with detailedinformationconsent form aboutthe study will the participanthave to decide whether or not toparticipate Provide yourrationale for the amount of timegiven

Once the participant contacts the study by email theconsent form will be sent to them by email to read throughbefore the first meeting The research coordinator willdiscuss the contents of the consent form with theparticipant one week prior to the UVB light exposureprotocol Thus participants will have 1-2 weeks to reviewthe consent form before making a decision aboutparticipation

69 Capacity to Consent Willevery participant have thecapacity to give fully informedconsent on hisher own behalfPlease click Select to completethe question and view furtherdetails

Will theparticipanthave thecapacityto givefullyinformedconsent

Details ofthe natureof theincapacity

If notwhowillconsentonhisherbehalf

If not willheshe beable to giveassent toparticipate

If Yesexplainhowassentwill besought

Yes [Details]

610 Renewal of ConsentDescribe any situation in whichthe renewal of consent for thisresearch might be appropriateand how this would take place

There are no plans for renewal of consent No furthercontact is required after obtaining the samples All samplesand data will be de-identified on collection and cannot betracked back to the subjects

611 Provisions for ConsentWhat provisions are planned forparticipants or those consentingon a participants behalf to havespecial assistance if neededduring the consent process (egconsent forms in Braille or inlanguages other than English)

Participants have to be able bodied to be able to participatein order to receive the UVB exposure Subjects with nounderstanding of the English language will not beapproached for involvement in the study unless a translatoris present who can converse in the first language of thesubject

612 Restrictions on DisclosureDescribe any restrictions

There are no restrictions on disclosure of information

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regarding the disclosure ofinformation to researchparticipants (during or at the endof the study) that the sponsorhas placed on investigatorsincluding those related to thepublication of results Alsoindicate any plans forcommunicating study results toparticipants7 Number of Participants and Study Drugs - Clinical Study [View Form]

71 Multi-Centre Studies 71A Is this a multi-centre study(involves centres outside ofthose applied for under thisApproval)

no

If known please list the othersites below

71B Is this study beingsubmitted for ethical approval toany other Research EthicsBoard

DescriptionNo

If yes please provide the nameof the REB(s) and if availablecontact information

72 Number of Participants 72A How many participants(including controls) will beenrolled in the entire study (iethe entire study world-wide)

30

72B How many participants(including controls) will beenrolled at institutions coveredby this Research EthicsApproval (ie only at theinstitutions covered by thisapproval)

30

72C Of these how many arecontrols 0

72D Please enter anyadditional comments

73 Drug approvals Enter thegeneric name of anyinvestigational drug(s) not yetapproved or any marketeddrug(s) used outside of itsapproved indication

NA

74 Marketed Drugs Enter thename of any marketed drug(s)

NA

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used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

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amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

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ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

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files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

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Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

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on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

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will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

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112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 8: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

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Simon Fraser University University of Alberta Universityof Northern British Columbia Northern Health Authority University of Saskatchewan University of Victoria IslandHealth Authority Fraser HealthAuthority Interior HealthAuthority Note If submitting anamendment for an alreadyapproved study you mustrespond ldquoNordquo to this question)4 Clinical Study Review Type (Q 47 48) [View Form]

47A Creation of a Registry(Data or Tissue Bank) Doesthis study involve the creation ofa registry (data or tissue bank)for future use in other research[if no skip to 48]

no

47B Is the purpose of thisapplication exclusively to obtainapproval for the creation of aresearch database registry ortissue bank [Note if the creationof the database or registry ortissue repository is part of abigger project also included inthis application you mustanswer no below]

no

Clinical Chart Review 48A Isthis an application for researchrequiring access to clinical chartsOR data from registries ordatabases such as PopData BCor Pharmanet

no

48B Insert the date range ofthe chartsdata to be included inthis research (eg 7 September2005 ndash 6 September 2011)

48C Is this study exclusively aretrospective chart review wherethe only source of data will bemedical chartsrecords that arecurrently in existence (ie willpre-date the date of your initialethics approval)

48D Are you collecting andretaining personally identifiableinformation to be a part of thedata set

48E Is this a retrospective

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chart review study for whichparticipant consent will beobtained5 Summary of Study and Recruitment - Clinical Study [View Form]

51 Study Summary 51A Provide a short summary of theproject written in lay languagesuitable for non-scientific REBmembers DO NOT exceed 100words and do not cut and pastedirectly from the study protocol

This research will explore the potential effects of Narrow-Band Ultra Violet B (NB-UVB) radiation on the intestinalmicrobiota composition and confirm a regulatory skin-to-gutaxis during baseline conditions Changes in the intestinalmicrobiota composition caused by NB-UVB phototherapycould be beneficial for patients with chronicauto-inflammatory diseases like IBD by removing dangerousbacteria increasing beneficial bacteria and ultimatelymodulating immune responses

51B Summarize the researchproposal Purpose Hypothesis Justification ObjectivesResearch Design and StatisticalAnalysis

Purpose To explore the potential effects of Narrow-Band Ultra VioletB (NB-UVB) radiation on the intestinal microbiotacomposition in humans and confirm a regulatory skin-to-gutaxis during baseline conditions Hypothesis Humans exposed to UVB-NB light will show changes in theintestinal microbiota composition with selection of certainphyla of bacteria Justification To date there is no data that describes a biologicalresponse to UVB light in the body that affects the intestinalmicrobiota Changes in the intestinal microbiotacomposition caused by NB-UVB phototherapy could bebeneficial for patients with chronicauto-inflammatorydiseases like IBD by removing dangerous bacteriaincreasing beneficial bacteria and ultimately modulatingimmune responses Objectives 1 Establish if there is an skin regulatory response towardsNB-UVB light in humans 2 Examine what changes in the microbiota compositioncan be observed on bacterial phyla and class level 3 Determine if this research is worth pursuing in a largercohort Research design During the first visit the skin type will be assessed by usingthe Fitzpatrick skin type questionnaire Subsequently subjects will be exposed three times withinone week to full body NB-UVB light in The Skin CareCentre to a sub erythemic dose (cause slight redness of theskin but not burning) The exposures will happen during thewinter months to prevent UVB exposure from the sunduring daily activities to interfere with our observationsStool samples will be collected before the first exposure(2x) and after the last exposure (2x) to analyse the

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microbiota composition Also serum vitamin D (25-hydroxyvitamin D) will be measured before and after the UVBexposure as a marker of previous UVB exposure before theexperiment Subjects will be healthy Caucasian females between 19-40years of age with a Fitzpatrick skin type I II or III tominimise the variability in skin responses towards the UVB-NB light since fair skin colour is less adapted to absorb theUVB radiation than dark coloured skin The microbiota composition will be analysed with 16S rRNAIllumina sequencing and calculated for differentialabundance on phylum level Statistical analysis The statistical analysis will focus the personal microbiotacomposition variation after NB-UVB light exposure incomparison to before the UVB light exposure Because wecollect two samples before and two samples after the UVBexposures each individual can serve as her own internalcontrol

52 Inclusion Criteria InclusionCriteria Describe theparticipants being selected forthis study and list the criteria fortheir inclusion For researchinvolving human pluripotent stemcells provide a detaileddescription of the stem cellsbeing used in the research

Healthy Caucasian females between 19-40 years of age Fitzpatrick skin type I II or III (see box 98A for Fitzpatrickskin type assessment)

53 Exclusion Criteria Exclusion Criteria Describewhich potential participants willbe excluded from participationand list the criteria for theirexclusion

The participants will be excluded if they have skin photosensitivity or taking medication that promotes photosensitivity of their skin Also participants that have been onvacation to a sunny destination since October 2017 or visittanning beds on a regular basis will be excluded becausethey have been exposed to UVB radiation

54 Recruitment Provide adetailed description of themethod of recruitment Includewhere applicable A) Who willcontact prospective participantsB) by what means this will bedone C) How prospectiveparticipants will be identified D)Ensure that any letters of initialcontact or other recruitmentmaterials are attached to thissubmission on Page 9

The recruitment will be done via social media withFacebook (UVBstudy page) The recruitment advertisementis included in the submission The researcher will contactprospective participants after they voluntarily contacted thestudy email address UVBstudyalumniubcca Initial contact will be through email conversation until thepotential participant expresses interest participating byemail Once the participant has signed the consent form astudy identifier will be assigned to the participant to protectthe individuals identity

55 Recruitment ofNormalControl Participants Describe how prospectivenormalcontrol participants will

Each participant will serve as her own control Allparticipants will be recruited the same way

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be identified contacted andrecruited if the method differsfrom the above56 Use of Records If existingrecords (eg health recordsclinical lists or otherrecordsdatabases) will be usedto IDENTIFY potentialparticipants or COLLECT DATAplease describe how permissionto access this information and tocollect and use this informationwill be obtained

No existing records will be used for this study

57 Summary of StudyProcedures

Participants will contact the study coordinator and will beinvited to participate by and email that will be sent alongwith the consent form A first meeting will be set upbetween the research coordinator and the participant at theSkin Care Center to explain the protocol and to signconsent forms Also four stool collection kits will be handedto the participant After signing the consent form theFitzpatrick skin type will be assessed with the hand of aquestionnaire about the sun exposure habits The participant is responsible to collect two stool samplesduring the week prior to the first light exposure and store itin her freezer at home On the Monday of the first NB-UVB exposure the researchcoordinator will confirm that a stool sample is collected bythe participant The participant will be referred to the lab atLife Labs to collect one blood sample (one tube of 15 mlapproximately one table spoon full) and will later go to TheSkin Care Centre at VGH where the participants will beassessed under supervision of dr Harvey Lui MD for theirfirst full body NB-UVB exposure The participants will wearspecialised goggles to protect the eyes from the UVB raysand wear broad spectrum sunscreen on face and hands toprotect these areas from the light The NB-UVB lightexposure will happen in a full body cabin like an uprighttanning bed and will take no longer than 5 minutes A timewill be scheduled for the next two sessions with theparticipants On Wednesday and Friday the participant willreceive a NB-UVB dose that is 10 higher than the fisrtvisit if tolerated well Description of blood collection procedure at Life Labs Ablood sample will be taken by first applying a tourniquet tothe upper arm The skin on the inner side of the elbow willbe sterilised and a small sterile needle will be inserted intothe vein Two blood collection tubes will then be attached tothe needle which will fill with blood When the tube is fullthe needle will be removed A plaster or small bandage will be applied to cover the site where the needle

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was removed Blood samples will be marked with their study identifiersand analysed in Life labs for of serum 25-hydroxy vitaminD3 according to Standards Council of Canadarsquos GoodLaboratory Practice (GLP) principles and Good ClinicalPractice (GCP) The participant is responsible to collect tw stool samplesthe week after the three NB-UVB light exposures and storeit in the freezer The research coordinator will contact theparticipant when and where to pick up the stool samples orparticipant can drop them off at their own convenience atthe Skin Care Centre during on Monday Wednesday andFriday nights The stool samples that are collected from the participantwill be stored in the BCCHR in a -80C freezer in a lockedlab until all samples from all participants are collectedOnce all stool samples are collected they will be send offto the Stintzi Lab at the University of Ottawa for 16S rRNAsequencing The results will be analysed and stored on theBCCHR password-secured computer

6 Participant Information and Consent Process - Clinical Study [View Form]

61 Time to Participate Howmuch time will a participant beasked to dedicate to the projectbeyond that needed for normalcare

The first visit to sign the consent form and do the Skin typeassessment will take approximately 20 minutes The visitfor the first UVB exposure will take approx 20 minutes toreview the exposure methods The next two visits will take approximately 10-12 minuteseach The visits for the blood draws will take about 30 minutesdepending on the amount of waiting time of the Life Labslocation The total time the participant will spend to this study will be2 hours minutes

62 Time to Participate ndashNormalControl Participants Ifapplicable how much time will anormalcontrol volunteer beasked to dedicate to the project

Each participant will be treated similarly

63 RisksHarms Describe whatis known about the risks(harms) of the proposedresearch

The exposure to NB-UVB light will turn the skin slightly pinkfor 1-2 days NB-UVB is ultraviolet radiation and couldcause long term effects after excessive exposure like skinageing and skin cancer The exposure from this study isequivalent to 5 min sun exposure during a summerrsquos dayper visit and is unlikely to have any long-term effects Short-term side effects may include skin redness skin drynesstriggering of a cold sore All of these effects are minor and

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will resolve usually within a week In rare cases the skinmight turn red and gives a sun burn-like sensation In thiscase the sensation will fade away over the next days Theparticipant should contact the researcher in this case Although minimal there is a 05 risk of bleeding from theneedle site If this occurs the subject can be given apressure bandage The risks of blood draw also includespain andor discomfort bruising fainting andor lightheaded sensation and the rare possibility of infection

64 Benefits Describe anypotential benefits to theparticipant that could arise fromhis or her participation in theproposed research

Exposure to NB-UVB will produce vitamin D in your skinthat helps against seasonal affective disorder (SAD) and isimportant for your general health

65 Reimbursement Describeany reimbursement for expenses(eg meals parkingmedications) orpaymentsincentivesgifts-in-kind(eg honoraria gifts prizescredits) to be offered to theparticipants Provide full detailsof the amounts paymentschedules and value of gifts-in-kind

There is a $750 budget for this study for the 30 testparticipants Each participant will be given a $25 gift-certificate when the stool samples are collected and theparticipant is done with the study requirements

66 Obtaining Consent SpecifyA) who will explain the consentform B) who will consentparticipants C) Include details ofwhere the consent will beobtained and under whatcircumstances and D) therelationship of the personobtaining consent andparticipant

Once the potential participants agree to participate to thestudy by email the consent form will be explained in personby the research coordinator The research coordinator willbe able to answer all questions about possible concernsand about the procedure The consent form will bediscussed in person with the participant in an office settingin the Skin Care Center Once the participants sign theconsent form they agree to be a part of the study Theparticipants will get the stool collection kits at that time andwill come back for the further procedures one week laterThe participant is free to withdraw from the study at anygiven time for the duration of the study The physicians at the Skin Care Centre will go through theprocedures with the participant and is able to answer anyquestions regarding the UVB exposure

67A WaiverAlteration ofConsent If you are asking for awaiver or an alteration of therequirement for participantinformed consent please justifythe waiver or alteration andexplain how the study meets allthe criteria on the right Pleaseclick Guidance Notes on rightand ensure that you address

There will be no waiver

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each criteria individually Includethe corresponding letter (A B CD E) before each answer67B Waiver of Consent inIndividual Medical EmergenciesIf you are asking for a waiver oran alteration of the requirementfor participant informed consentin individual medicalemergencies please justify thewaiver or alteration and explainhow the study meets all thecriteria on the right Please clickGuidance Notes on right andensure that you address eachcriteria individually Include thecorresponding letter (A B C DE) before each answer

NA

68 Time to Consent How longafter being provided with detailedinformationconsent form aboutthe study will the participanthave to decide whether or not toparticipate Provide yourrationale for the amount of timegiven

Once the participant contacts the study by email theconsent form will be sent to them by email to read throughbefore the first meeting The research coordinator willdiscuss the contents of the consent form with theparticipant one week prior to the UVB light exposureprotocol Thus participants will have 1-2 weeks to reviewthe consent form before making a decision aboutparticipation

69 Capacity to Consent Willevery participant have thecapacity to give fully informedconsent on hisher own behalfPlease click Select to completethe question and view furtherdetails

Will theparticipanthave thecapacityto givefullyinformedconsent

Details ofthe natureof theincapacity

If notwhowillconsentonhisherbehalf

If not willheshe beable to giveassent toparticipate

If Yesexplainhowassentwill besought

Yes [Details]

610 Renewal of ConsentDescribe any situation in whichthe renewal of consent for thisresearch might be appropriateand how this would take place

There are no plans for renewal of consent No furthercontact is required after obtaining the samples All samplesand data will be de-identified on collection and cannot betracked back to the subjects

611 Provisions for ConsentWhat provisions are planned forparticipants or those consentingon a participants behalf to havespecial assistance if neededduring the consent process (egconsent forms in Braille or inlanguages other than English)

Participants have to be able bodied to be able to participatein order to receive the UVB exposure Subjects with nounderstanding of the English language will not beapproached for involvement in the study unless a translatoris present who can converse in the first language of thesubject

612 Restrictions on DisclosureDescribe any restrictions

There are no restrictions on disclosure of information

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regarding the disclosure ofinformation to researchparticipants (during or at the endof the study) that the sponsorhas placed on investigatorsincluding those related to thepublication of results Alsoindicate any plans forcommunicating study results toparticipants7 Number of Participants and Study Drugs - Clinical Study [View Form]

71 Multi-Centre Studies 71A Is this a multi-centre study(involves centres outside ofthose applied for under thisApproval)

no

If known please list the othersites below

71B Is this study beingsubmitted for ethical approval toany other Research EthicsBoard

DescriptionNo

If yes please provide the nameof the REB(s) and if availablecontact information

72 Number of Participants 72A How many participants(including controls) will beenrolled in the entire study (iethe entire study world-wide)

30

72B How many participants(including controls) will beenrolled at institutions coveredby this Research EthicsApproval (ie only at theinstitutions covered by thisapproval)

30

72C Of these how many arecontrols 0

72D Please enter anyadditional comments

73 Drug approvals Enter thegeneric name of anyinvestigational drug(s) not yetapproved or any marketeddrug(s) used outside of itsapproved indication

NA

74 Marketed Drugs Enter thename of any marketed drug(s)

NA

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used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

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amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

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ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

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files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

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Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

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on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

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will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

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112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 9: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

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chart review study for whichparticipant consent will beobtained5 Summary of Study and Recruitment - Clinical Study [View Form]

51 Study Summary 51A Provide a short summary of theproject written in lay languagesuitable for non-scientific REBmembers DO NOT exceed 100words and do not cut and pastedirectly from the study protocol

This research will explore the potential effects of Narrow-Band Ultra Violet B (NB-UVB) radiation on the intestinalmicrobiota composition and confirm a regulatory skin-to-gutaxis during baseline conditions Changes in the intestinalmicrobiota composition caused by NB-UVB phototherapycould be beneficial for patients with chronicauto-inflammatory diseases like IBD by removing dangerousbacteria increasing beneficial bacteria and ultimatelymodulating immune responses

51B Summarize the researchproposal Purpose Hypothesis Justification ObjectivesResearch Design and StatisticalAnalysis

Purpose To explore the potential effects of Narrow-Band Ultra VioletB (NB-UVB) radiation on the intestinal microbiotacomposition in humans and confirm a regulatory skin-to-gutaxis during baseline conditions Hypothesis Humans exposed to UVB-NB light will show changes in theintestinal microbiota composition with selection of certainphyla of bacteria Justification To date there is no data that describes a biologicalresponse to UVB light in the body that affects the intestinalmicrobiota Changes in the intestinal microbiotacomposition caused by NB-UVB phototherapy could bebeneficial for patients with chronicauto-inflammatorydiseases like IBD by removing dangerous bacteriaincreasing beneficial bacteria and ultimately modulatingimmune responses Objectives 1 Establish if there is an skin regulatory response towardsNB-UVB light in humans 2 Examine what changes in the microbiota compositioncan be observed on bacterial phyla and class level 3 Determine if this research is worth pursuing in a largercohort Research design During the first visit the skin type will be assessed by usingthe Fitzpatrick skin type questionnaire Subsequently subjects will be exposed three times withinone week to full body NB-UVB light in The Skin CareCentre to a sub erythemic dose (cause slight redness of theskin but not burning) The exposures will happen during thewinter months to prevent UVB exposure from the sunduring daily activities to interfere with our observationsStool samples will be collected before the first exposure(2x) and after the last exposure (2x) to analyse the

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microbiota composition Also serum vitamin D (25-hydroxyvitamin D) will be measured before and after the UVBexposure as a marker of previous UVB exposure before theexperiment Subjects will be healthy Caucasian females between 19-40years of age with a Fitzpatrick skin type I II or III tominimise the variability in skin responses towards the UVB-NB light since fair skin colour is less adapted to absorb theUVB radiation than dark coloured skin The microbiota composition will be analysed with 16S rRNAIllumina sequencing and calculated for differentialabundance on phylum level Statistical analysis The statistical analysis will focus the personal microbiotacomposition variation after NB-UVB light exposure incomparison to before the UVB light exposure Because wecollect two samples before and two samples after the UVBexposures each individual can serve as her own internalcontrol

52 Inclusion Criteria InclusionCriteria Describe theparticipants being selected forthis study and list the criteria fortheir inclusion For researchinvolving human pluripotent stemcells provide a detaileddescription of the stem cellsbeing used in the research

Healthy Caucasian females between 19-40 years of age Fitzpatrick skin type I II or III (see box 98A for Fitzpatrickskin type assessment)

53 Exclusion Criteria Exclusion Criteria Describewhich potential participants willbe excluded from participationand list the criteria for theirexclusion

The participants will be excluded if they have skin photosensitivity or taking medication that promotes photosensitivity of their skin Also participants that have been onvacation to a sunny destination since October 2017 or visittanning beds on a regular basis will be excluded becausethey have been exposed to UVB radiation

54 Recruitment Provide adetailed description of themethod of recruitment Includewhere applicable A) Who willcontact prospective participantsB) by what means this will bedone C) How prospectiveparticipants will be identified D)Ensure that any letters of initialcontact or other recruitmentmaterials are attached to thissubmission on Page 9

The recruitment will be done via social media withFacebook (UVBstudy page) The recruitment advertisementis included in the submission The researcher will contactprospective participants after they voluntarily contacted thestudy email address UVBstudyalumniubcca Initial contact will be through email conversation until thepotential participant expresses interest participating byemail Once the participant has signed the consent form astudy identifier will be assigned to the participant to protectthe individuals identity

55 Recruitment ofNormalControl Participants Describe how prospectivenormalcontrol participants will

Each participant will serve as her own control Allparticipants will be recruited the same way

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be identified contacted andrecruited if the method differsfrom the above56 Use of Records If existingrecords (eg health recordsclinical lists or otherrecordsdatabases) will be usedto IDENTIFY potentialparticipants or COLLECT DATAplease describe how permissionto access this information and tocollect and use this informationwill be obtained

No existing records will be used for this study

57 Summary of StudyProcedures

Participants will contact the study coordinator and will beinvited to participate by and email that will be sent alongwith the consent form A first meeting will be set upbetween the research coordinator and the participant at theSkin Care Center to explain the protocol and to signconsent forms Also four stool collection kits will be handedto the participant After signing the consent form theFitzpatrick skin type will be assessed with the hand of aquestionnaire about the sun exposure habits The participant is responsible to collect two stool samplesduring the week prior to the first light exposure and store itin her freezer at home On the Monday of the first NB-UVB exposure the researchcoordinator will confirm that a stool sample is collected bythe participant The participant will be referred to the lab atLife Labs to collect one blood sample (one tube of 15 mlapproximately one table spoon full) and will later go to TheSkin Care Centre at VGH where the participants will beassessed under supervision of dr Harvey Lui MD for theirfirst full body NB-UVB exposure The participants will wearspecialised goggles to protect the eyes from the UVB raysand wear broad spectrum sunscreen on face and hands toprotect these areas from the light The NB-UVB lightexposure will happen in a full body cabin like an uprighttanning bed and will take no longer than 5 minutes A timewill be scheduled for the next two sessions with theparticipants On Wednesday and Friday the participant willreceive a NB-UVB dose that is 10 higher than the fisrtvisit if tolerated well Description of blood collection procedure at Life Labs Ablood sample will be taken by first applying a tourniquet tothe upper arm The skin on the inner side of the elbow willbe sterilised and a small sterile needle will be inserted intothe vein Two blood collection tubes will then be attached tothe needle which will fill with blood When the tube is fullthe needle will be removed A plaster or small bandage will be applied to cover the site where the needle

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was removed Blood samples will be marked with their study identifiersand analysed in Life labs for of serum 25-hydroxy vitaminD3 according to Standards Council of Canadarsquos GoodLaboratory Practice (GLP) principles and Good ClinicalPractice (GCP) The participant is responsible to collect tw stool samplesthe week after the three NB-UVB light exposures and storeit in the freezer The research coordinator will contact theparticipant when and where to pick up the stool samples orparticipant can drop them off at their own convenience atthe Skin Care Centre during on Monday Wednesday andFriday nights The stool samples that are collected from the participantwill be stored in the BCCHR in a -80C freezer in a lockedlab until all samples from all participants are collectedOnce all stool samples are collected they will be send offto the Stintzi Lab at the University of Ottawa for 16S rRNAsequencing The results will be analysed and stored on theBCCHR password-secured computer

6 Participant Information and Consent Process - Clinical Study [View Form]

61 Time to Participate Howmuch time will a participant beasked to dedicate to the projectbeyond that needed for normalcare

The first visit to sign the consent form and do the Skin typeassessment will take approximately 20 minutes The visitfor the first UVB exposure will take approx 20 minutes toreview the exposure methods The next two visits will take approximately 10-12 minuteseach The visits for the blood draws will take about 30 minutesdepending on the amount of waiting time of the Life Labslocation The total time the participant will spend to this study will be2 hours minutes

62 Time to Participate ndashNormalControl Participants Ifapplicable how much time will anormalcontrol volunteer beasked to dedicate to the project

Each participant will be treated similarly

63 RisksHarms Describe whatis known about the risks(harms) of the proposedresearch

The exposure to NB-UVB light will turn the skin slightly pinkfor 1-2 days NB-UVB is ultraviolet radiation and couldcause long term effects after excessive exposure like skinageing and skin cancer The exposure from this study isequivalent to 5 min sun exposure during a summerrsquos dayper visit and is unlikely to have any long-term effects Short-term side effects may include skin redness skin drynesstriggering of a cold sore All of these effects are minor and

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will resolve usually within a week In rare cases the skinmight turn red and gives a sun burn-like sensation In thiscase the sensation will fade away over the next days Theparticipant should contact the researcher in this case Although minimal there is a 05 risk of bleeding from theneedle site If this occurs the subject can be given apressure bandage The risks of blood draw also includespain andor discomfort bruising fainting andor lightheaded sensation and the rare possibility of infection

64 Benefits Describe anypotential benefits to theparticipant that could arise fromhis or her participation in theproposed research

Exposure to NB-UVB will produce vitamin D in your skinthat helps against seasonal affective disorder (SAD) and isimportant for your general health

65 Reimbursement Describeany reimbursement for expenses(eg meals parkingmedications) orpaymentsincentivesgifts-in-kind(eg honoraria gifts prizescredits) to be offered to theparticipants Provide full detailsof the amounts paymentschedules and value of gifts-in-kind

There is a $750 budget for this study for the 30 testparticipants Each participant will be given a $25 gift-certificate when the stool samples are collected and theparticipant is done with the study requirements

66 Obtaining Consent SpecifyA) who will explain the consentform B) who will consentparticipants C) Include details ofwhere the consent will beobtained and under whatcircumstances and D) therelationship of the personobtaining consent andparticipant

Once the potential participants agree to participate to thestudy by email the consent form will be explained in personby the research coordinator The research coordinator willbe able to answer all questions about possible concernsand about the procedure The consent form will bediscussed in person with the participant in an office settingin the Skin Care Center Once the participants sign theconsent form they agree to be a part of the study Theparticipants will get the stool collection kits at that time andwill come back for the further procedures one week laterThe participant is free to withdraw from the study at anygiven time for the duration of the study The physicians at the Skin Care Centre will go through theprocedures with the participant and is able to answer anyquestions regarding the UVB exposure

67A WaiverAlteration ofConsent If you are asking for awaiver or an alteration of therequirement for participantinformed consent please justifythe waiver or alteration andexplain how the study meets allthe criteria on the right Pleaseclick Guidance Notes on rightand ensure that you address

There will be no waiver

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each criteria individually Includethe corresponding letter (A B CD E) before each answer67B Waiver of Consent inIndividual Medical EmergenciesIf you are asking for a waiver oran alteration of the requirementfor participant informed consentin individual medicalemergencies please justify thewaiver or alteration and explainhow the study meets all thecriteria on the right Please clickGuidance Notes on right andensure that you address eachcriteria individually Include thecorresponding letter (A B C DE) before each answer

NA

68 Time to Consent How longafter being provided with detailedinformationconsent form aboutthe study will the participanthave to decide whether or not toparticipate Provide yourrationale for the amount of timegiven

Once the participant contacts the study by email theconsent form will be sent to them by email to read throughbefore the first meeting The research coordinator willdiscuss the contents of the consent form with theparticipant one week prior to the UVB light exposureprotocol Thus participants will have 1-2 weeks to reviewthe consent form before making a decision aboutparticipation

69 Capacity to Consent Willevery participant have thecapacity to give fully informedconsent on hisher own behalfPlease click Select to completethe question and view furtherdetails

Will theparticipanthave thecapacityto givefullyinformedconsent

Details ofthe natureof theincapacity

If notwhowillconsentonhisherbehalf

If not willheshe beable to giveassent toparticipate

If Yesexplainhowassentwill besought

Yes [Details]

610 Renewal of ConsentDescribe any situation in whichthe renewal of consent for thisresearch might be appropriateand how this would take place

There are no plans for renewal of consent No furthercontact is required after obtaining the samples All samplesand data will be de-identified on collection and cannot betracked back to the subjects

611 Provisions for ConsentWhat provisions are planned forparticipants or those consentingon a participants behalf to havespecial assistance if neededduring the consent process (egconsent forms in Braille or inlanguages other than English)

Participants have to be able bodied to be able to participatein order to receive the UVB exposure Subjects with nounderstanding of the English language will not beapproached for involvement in the study unless a translatoris present who can converse in the first language of thesubject

612 Restrictions on DisclosureDescribe any restrictions

There are no restrictions on disclosure of information

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regarding the disclosure ofinformation to researchparticipants (during or at the endof the study) that the sponsorhas placed on investigatorsincluding those related to thepublication of results Alsoindicate any plans forcommunicating study results toparticipants7 Number of Participants and Study Drugs - Clinical Study [View Form]

71 Multi-Centre Studies 71A Is this a multi-centre study(involves centres outside ofthose applied for under thisApproval)

no

If known please list the othersites below

71B Is this study beingsubmitted for ethical approval toany other Research EthicsBoard

DescriptionNo

If yes please provide the nameof the REB(s) and if availablecontact information

72 Number of Participants 72A How many participants(including controls) will beenrolled in the entire study (iethe entire study world-wide)

30

72B How many participants(including controls) will beenrolled at institutions coveredby this Research EthicsApproval (ie only at theinstitutions covered by thisapproval)

30

72C Of these how many arecontrols 0

72D Please enter anyadditional comments

73 Drug approvals Enter thegeneric name of anyinvestigational drug(s) not yetapproved or any marketeddrug(s) used outside of itsapproved indication

NA

74 Marketed Drugs Enter thename of any marketed drug(s)

NA

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used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

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amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

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ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

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files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

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Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

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on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

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will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

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112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 10: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

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microbiota composition Also serum vitamin D (25-hydroxyvitamin D) will be measured before and after the UVBexposure as a marker of previous UVB exposure before theexperiment Subjects will be healthy Caucasian females between 19-40years of age with a Fitzpatrick skin type I II or III tominimise the variability in skin responses towards the UVB-NB light since fair skin colour is less adapted to absorb theUVB radiation than dark coloured skin The microbiota composition will be analysed with 16S rRNAIllumina sequencing and calculated for differentialabundance on phylum level Statistical analysis The statistical analysis will focus the personal microbiotacomposition variation after NB-UVB light exposure incomparison to before the UVB light exposure Because wecollect two samples before and two samples after the UVBexposures each individual can serve as her own internalcontrol

52 Inclusion Criteria InclusionCriteria Describe theparticipants being selected forthis study and list the criteria fortheir inclusion For researchinvolving human pluripotent stemcells provide a detaileddescription of the stem cellsbeing used in the research

Healthy Caucasian females between 19-40 years of age Fitzpatrick skin type I II or III (see box 98A for Fitzpatrickskin type assessment)

53 Exclusion Criteria Exclusion Criteria Describewhich potential participants willbe excluded from participationand list the criteria for theirexclusion

The participants will be excluded if they have skin photosensitivity or taking medication that promotes photosensitivity of their skin Also participants that have been onvacation to a sunny destination since October 2017 or visittanning beds on a regular basis will be excluded becausethey have been exposed to UVB radiation

54 Recruitment Provide adetailed description of themethod of recruitment Includewhere applicable A) Who willcontact prospective participantsB) by what means this will bedone C) How prospectiveparticipants will be identified D)Ensure that any letters of initialcontact or other recruitmentmaterials are attached to thissubmission on Page 9

The recruitment will be done via social media withFacebook (UVBstudy page) The recruitment advertisementis included in the submission The researcher will contactprospective participants after they voluntarily contacted thestudy email address UVBstudyalumniubcca Initial contact will be through email conversation until thepotential participant expresses interest participating byemail Once the participant has signed the consent form astudy identifier will be assigned to the participant to protectthe individuals identity

55 Recruitment ofNormalControl Participants Describe how prospectivenormalcontrol participants will

Each participant will serve as her own control Allparticipants will be recruited the same way

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be identified contacted andrecruited if the method differsfrom the above56 Use of Records If existingrecords (eg health recordsclinical lists or otherrecordsdatabases) will be usedto IDENTIFY potentialparticipants or COLLECT DATAplease describe how permissionto access this information and tocollect and use this informationwill be obtained

No existing records will be used for this study

57 Summary of StudyProcedures

Participants will contact the study coordinator and will beinvited to participate by and email that will be sent alongwith the consent form A first meeting will be set upbetween the research coordinator and the participant at theSkin Care Center to explain the protocol and to signconsent forms Also four stool collection kits will be handedto the participant After signing the consent form theFitzpatrick skin type will be assessed with the hand of aquestionnaire about the sun exposure habits The participant is responsible to collect two stool samplesduring the week prior to the first light exposure and store itin her freezer at home On the Monday of the first NB-UVB exposure the researchcoordinator will confirm that a stool sample is collected bythe participant The participant will be referred to the lab atLife Labs to collect one blood sample (one tube of 15 mlapproximately one table spoon full) and will later go to TheSkin Care Centre at VGH where the participants will beassessed under supervision of dr Harvey Lui MD for theirfirst full body NB-UVB exposure The participants will wearspecialised goggles to protect the eyes from the UVB raysand wear broad spectrum sunscreen on face and hands toprotect these areas from the light The NB-UVB lightexposure will happen in a full body cabin like an uprighttanning bed and will take no longer than 5 minutes A timewill be scheduled for the next two sessions with theparticipants On Wednesday and Friday the participant willreceive a NB-UVB dose that is 10 higher than the fisrtvisit if tolerated well Description of blood collection procedure at Life Labs Ablood sample will be taken by first applying a tourniquet tothe upper arm The skin on the inner side of the elbow willbe sterilised and a small sterile needle will be inserted intothe vein Two blood collection tubes will then be attached tothe needle which will fill with blood When the tube is fullthe needle will be removed A plaster or small bandage will be applied to cover the site where the needle

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was removed Blood samples will be marked with their study identifiersand analysed in Life labs for of serum 25-hydroxy vitaminD3 according to Standards Council of Canadarsquos GoodLaboratory Practice (GLP) principles and Good ClinicalPractice (GCP) The participant is responsible to collect tw stool samplesthe week after the three NB-UVB light exposures and storeit in the freezer The research coordinator will contact theparticipant when and where to pick up the stool samples orparticipant can drop them off at their own convenience atthe Skin Care Centre during on Monday Wednesday andFriday nights The stool samples that are collected from the participantwill be stored in the BCCHR in a -80C freezer in a lockedlab until all samples from all participants are collectedOnce all stool samples are collected they will be send offto the Stintzi Lab at the University of Ottawa for 16S rRNAsequencing The results will be analysed and stored on theBCCHR password-secured computer

6 Participant Information and Consent Process - Clinical Study [View Form]

61 Time to Participate Howmuch time will a participant beasked to dedicate to the projectbeyond that needed for normalcare

The first visit to sign the consent form and do the Skin typeassessment will take approximately 20 minutes The visitfor the first UVB exposure will take approx 20 minutes toreview the exposure methods The next two visits will take approximately 10-12 minuteseach The visits for the blood draws will take about 30 minutesdepending on the amount of waiting time of the Life Labslocation The total time the participant will spend to this study will be2 hours minutes

62 Time to Participate ndashNormalControl Participants Ifapplicable how much time will anormalcontrol volunteer beasked to dedicate to the project

Each participant will be treated similarly

63 RisksHarms Describe whatis known about the risks(harms) of the proposedresearch

The exposure to NB-UVB light will turn the skin slightly pinkfor 1-2 days NB-UVB is ultraviolet radiation and couldcause long term effects after excessive exposure like skinageing and skin cancer The exposure from this study isequivalent to 5 min sun exposure during a summerrsquos dayper visit and is unlikely to have any long-term effects Short-term side effects may include skin redness skin drynesstriggering of a cold sore All of these effects are minor and

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will resolve usually within a week In rare cases the skinmight turn red and gives a sun burn-like sensation In thiscase the sensation will fade away over the next days Theparticipant should contact the researcher in this case Although minimal there is a 05 risk of bleeding from theneedle site If this occurs the subject can be given apressure bandage The risks of blood draw also includespain andor discomfort bruising fainting andor lightheaded sensation and the rare possibility of infection

64 Benefits Describe anypotential benefits to theparticipant that could arise fromhis or her participation in theproposed research

Exposure to NB-UVB will produce vitamin D in your skinthat helps against seasonal affective disorder (SAD) and isimportant for your general health

65 Reimbursement Describeany reimbursement for expenses(eg meals parkingmedications) orpaymentsincentivesgifts-in-kind(eg honoraria gifts prizescredits) to be offered to theparticipants Provide full detailsof the amounts paymentschedules and value of gifts-in-kind

There is a $750 budget for this study for the 30 testparticipants Each participant will be given a $25 gift-certificate when the stool samples are collected and theparticipant is done with the study requirements

66 Obtaining Consent SpecifyA) who will explain the consentform B) who will consentparticipants C) Include details ofwhere the consent will beobtained and under whatcircumstances and D) therelationship of the personobtaining consent andparticipant

Once the potential participants agree to participate to thestudy by email the consent form will be explained in personby the research coordinator The research coordinator willbe able to answer all questions about possible concernsand about the procedure The consent form will bediscussed in person with the participant in an office settingin the Skin Care Center Once the participants sign theconsent form they agree to be a part of the study Theparticipants will get the stool collection kits at that time andwill come back for the further procedures one week laterThe participant is free to withdraw from the study at anygiven time for the duration of the study The physicians at the Skin Care Centre will go through theprocedures with the participant and is able to answer anyquestions regarding the UVB exposure

67A WaiverAlteration ofConsent If you are asking for awaiver or an alteration of therequirement for participantinformed consent please justifythe waiver or alteration andexplain how the study meets allthe criteria on the right Pleaseclick Guidance Notes on rightand ensure that you address

There will be no waiver

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each criteria individually Includethe corresponding letter (A B CD E) before each answer67B Waiver of Consent inIndividual Medical EmergenciesIf you are asking for a waiver oran alteration of the requirementfor participant informed consentin individual medicalemergencies please justify thewaiver or alteration and explainhow the study meets all thecriteria on the right Please clickGuidance Notes on right andensure that you address eachcriteria individually Include thecorresponding letter (A B C DE) before each answer

NA

68 Time to Consent How longafter being provided with detailedinformationconsent form aboutthe study will the participanthave to decide whether or not toparticipate Provide yourrationale for the amount of timegiven

Once the participant contacts the study by email theconsent form will be sent to them by email to read throughbefore the first meeting The research coordinator willdiscuss the contents of the consent form with theparticipant one week prior to the UVB light exposureprotocol Thus participants will have 1-2 weeks to reviewthe consent form before making a decision aboutparticipation

69 Capacity to Consent Willevery participant have thecapacity to give fully informedconsent on hisher own behalfPlease click Select to completethe question and view furtherdetails

Will theparticipanthave thecapacityto givefullyinformedconsent

Details ofthe natureof theincapacity

If notwhowillconsentonhisherbehalf

If not willheshe beable to giveassent toparticipate

If Yesexplainhowassentwill besought

Yes [Details]

610 Renewal of ConsentDescribe any situation in whichthe renewal of consent for thisresearch might be appropriateand how this would take place

There are no plans for renewal of consent No furthercontact is required after obtaining the samples All samplesand data will be de-identified on collection and cannot betracked back to the subjects

611 Provisions for ConsentWhat provisions are planned forparticipants or those consentingon a participants behalf to havespecial assistance if neededduring the consent process (egconsent forms in Braille or inlanguages other than English)

Participants have to be able bodied to be able to participatein order to receive the UVB exposure Subjects with nounderstanding of the English language will not beapproached for involvement in the study unless a translatoris present who can converse in the first language of thesubject

612 Restrictions on DisclosureDescribe any restrictions

There are no restrictions on disclosure of information

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regarding the disclosure ofinformation to researchparticipants (during or at the endof the study) that the sponsorhas placed on investigatorsincluding those related to thepublication of results Alsoindicate any plans forcommunicating study results toparticipants7 Number of Participants and Study Drugs - Clinical Study [View Form]

71 Multi-Centre Studies 71A Is this a multi-centre study(involves centres outside ofthose applied for under thisApproval)

no

If known please list the othersites below

71B Is this study beingsubmitted for ethical approval toany other Research EthicsBoard

DescriptionNo

If yes please provide the nameof the REB(s) and if availablecontact information

72 Number of Participants 72A How many participants(including controls) will beenrolled in the entire study (iethe entire study world-wide)

30

72B How many participants(including controls) will beenrolled at institutions coveredby this Research EthicsApproval (ie only at theinstitutions covered by thisapproval)

30

72C Of these how many arecontrols 0

72D Please enter anyadditional comments

73 Drug approvals Enter thegeneric name of anyinvestigational drug(s) not yetapproved or any marketeddrug(s) used outside of itsapproved indication

NA

74 Marketed Drugs Enter thename of any marketed drug(s)

NA

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used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

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amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

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ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

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files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

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Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

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on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

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will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

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112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 11: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

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be identified contacted andrecruited if the method differsfrom the above56 Use of Records If existingrecords (eg health recordsclinical lists or otherrecordsdatabases) will be usedto IDENTIFY potentialparticipants or COLLECT DATAplease describe how permissionto access this information and tocollect and use this informationwill be obtained

No existing records will be used for this study

57 Summary of StudyProcedures

Participants will contact the study coordinator and will beinvited to participate by and email that will be sent alongwith the consent form A first meeting will be set upbetween the research coordinator and the participant at theSkin Care Center to explain the protocol and to signconsent forms Also four stool collection kits will be handedto the participant After signing the consent form theFitzpatrick skin type will be assessed with the hand of aquestionnaire about the sun exposure habits The participant is responsible to collect two stool samplesduring the week prior to the first light exposure and store itin her freezer at home On the Monday of the first NB-UVB exposure the researchcoordinator will confirm that a stool sample is collected bythe participant The participant will be referred to the lab atLife Labs to collect one blood sample (one tube of 15 mlapproximately one table spoon full) and will later go to TheSkin Care Centre at VGH where the participants will beassessed under supervision of dr Harvey Lui MD for theirfirst full body NB-UVB exposure The participants will wearspecialised goggles to protect the eyes from the UVB raysand wear broad spectrum sunscreen on face and hands toprotect these areas from the light The NB-UVB lightexposure will happen in a full body cabin like an uprighttanning bed and will take no longer than 5 minutes A timewill be scheduled for the next two sessions with theparticipants On Wednesday and Friday the participant willreceive a NB-UVB dose that is 10 higher than the fisrtvisit if tolerated well Description of blood collection procedure at Life Labs Ablood sample will be taken by first applying a tourniquet tothe upper arm The skin on the inner side of the elbow willbe sterilised and a small sterile needle will be inserted intothe vein Two blood collection tubes will then be attached tothe needle which will fill with blood When the tube is fullthe needle will be removed A plaster or small bandage will be applied to cover the site where the needle

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was removed Blood samples will be marked with their study identifiersand analysed in Life labs for of serum 25-hydroxy vitaminD3 according to Standards Council of Canadarsquos GoodLaboratory Practice (GLP) principles and Good ClinicalPractice (GCP) The participant is responsible to collect tw stool samplesthe week after the three NB-UVB light exposures and storeit in the freezer The research coordinator will contact theparticipant when and where to pick up the stool samples orparticipant can drop them off at their own convenience atthe Skin Care Centre during on Monday Wednesday andFriday nights The stool samples that are collected from the participantwill be stored in the BCCHR in a -80C freezer in a lockedlab until all samples from all participants are collectedOnce all stool samples are collected they will be send offto the Stintzi Lab at the University of Ottawa for 16S rRNAsequencing The results will be analysed and stored on theBCCHR password-secured computer

6 Participant Information and Consent Process - Clinical Study [View Form]

61 Time to Participate Howmuch time will a participant beasked to dedicate to the projectbeyond that needed for normalcare

The first visit to sign the consent form and do the Skin typeassessment will take approximately 20 minutes The visitfor the first UVB exposure will take approx 20 minutes toreview the exposure methods The next two visits will take approximately 10-12 minuteseach The visits for the blood draws will take about 30 minutesdepending on the amount of waiting time of the Life Labslocation The total time the participant will spend to this study will be2 hours minutes

62 Time to Participate ndashNormalControl Participants Ifapplicable how much time will anormalcontrol volunteer beasked to dedicate to the project

Each participant will be treated similarly

63 RisksHarms Describe whatis known about the risks(harms) of the proposedresearch

The exposure to NB-UVB light will turn the skin slightly pinkfor 1-2 days NB-UVB is ultraviolet radiation and couldcause long term effects after excessive exposure like skinageing and skin cancer The exposure from this study isequivalent to 5 min sun exposure during a summerrsquos dayper visit and is unlikely to have any long-term effects Short-term side effects may include skin redness skin drynesstriggering of a cold sore All of these effects are minor and

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will resolve usually within a week In rare cases the skinmight turn red and gives a sun burn-like sensation In thiscase the sensation will fade away over the next days Theparticipant should contact the researcher in this case Although minimal there is a 05 risk of bleeding from theneedle site If this occurs the subject can be given apressure bandage The risks of blood draw also includespain andor discomfort bruising fainting andor lightheaded sensation and the rare possibility of infection

64 Benefits Describe anypotential benefits to theparticipant that could arise fromhis or her participation in theproposed research

Exposure to NB-UVB will produce vitamin D in your skinthat helps against seasonal affective disorder (SAD) and isimportant for your general health

65 Reimbursement Describeany reimbursement for expenses(eg meals parkingmedications) orpaymentsincentivesgifts-in-kind(eg honoraria gifts prizescredits) to be offered to theparticipants Provide full detailsof the amounts paymentschedules and value of gifts-in-kind

There is a $750 budget for this study for the 30 testparticipants Each participant will be given a $25 gift-certificate when the stool samples are collected and theparticipant is done with the study requirements

66 Obtaining Consent SpecifyA) who will explain the consentform B) who will consentparticipants C) Include details ofwhere the consent will beobtained and under whatcircumstances and D) therelationship of the personobtaining consent andparticipant

Once the potential participants agree to participate to thestudy by email the consent form will be explained in personby the research coordinator The research coordinator willbe able to answer all questions about possible concernsand about the procedure The consent form will bediscussed in person with the participant in an office settingin the Skin Care Center Once the participants sign theconsent form they agree to be a part of the study Theparticipants will get the stool collection kits at that time andwill come back for the further procedures one week laterThe participant is free to withdraw from the study at anygiven time for the duration of the study The physicians at the Skin Care Centre will go through theprocedures with the participant and is able to answer anyquestions regarding the UVB exposure

67A WaiverAlteration ofConsent If you are asking for awaiver or an alteration of therequirement for participantinformed consent please justifythe waiver or alteration andexplain how the study meets allthe criteria on the right Pleaseclick Guidance Notes on rightand ensure that you address

There will be no waiver

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each criteria individually Includethe corresponding letter (A B CD E) before each answer67B Waiver of Consent inIndividual Medical EmergenciesIf you are asking for a waiver oran alteration of the requirementfor participant informed consentin individual medicalemergencies please justify thewaiver or alteration and explainhow the study meets all thecriteria on the right Please clickGuidance Notes on right andensure that you address eachcriteria individually Include thecorresponding letter (A B C DE) before each answer

NA

68 Time to Consent How longafter being provided with detailedinformationconsent form aboutthe study will the participanthave to decide whether or not toparticipate Provide yourrationale for the amount of timegiven

Once the participant contacts the study by email theconsent form will be sent to them by email to read throughbefore the first meeting The research coordinator willdiscuss the contents of the consent form with theparticipant one week prior to the UVB light exposureprotocol Thus participants will have 1-2 weeks to reviewthe consent form before making a decision aboutparticipation

69 Capacity to Consent Willevery participant have thecapacity to give fully informedconsent on hisher own behalfPlease click Select to completethe question and view furtherdetails

Will theparticipanthave thecapacityto givefullyinformedconsent

Details ofthe natureof theincapacity

If notwhowillconsentonhisherbehalf

If not willheshe beable to giveassent toparticipate

If Yesexplainhowassentwill besought

Yes [Details]

610 Renewal of ConsentDescribe any situation in whichthe renewal of consent for thisresearch might be appropriateand how this would take place

There are no plans for renewal of consent No furthercontact is required after obtaining the samples All samplesand data will be de-identified on collection and cannot betracked back to the subjects

611 Provisions for ConsentWhat provisions are planned forparticipants or those consentingon a participants behalf to havespecial assistance if neededduring the consent process (egconsent forms in Braille or inlanguages other than English)

Participants have to be able bodied to be able to participatein order to receive the UVB exposure Subjects with nounderstanding of the English language will not beapproached for involvement in the study unless a translatoris present who can converse in the first language of thesubject

612 Restrictions on DisclosureDescribe any restrictions

There are no restrictions on disclosure of information

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regarding the disclosure ofinformation to researchparticipants (during or at the endof the study) that the sponsorhas placed on investigatorsincluding those related to thepublication of results Alsoindicate any plans forcommunicating study results toparticipants7 Number of Participants and Study Drugs - Clinical Study [View Form]

71 Multi-Centre Studies 71A Is this a multi-centre study(involves centres outside ofthose applied for under thisApproval)

no

If known please list the othersites below

71B Is this study beingsubmitted for ethical approval toany other Research EthicsBoard

DescriptionNo

If yes please provide the nameof the REB(s) and if availablecontact information

72 Number of Participants 72A How many participants(including controls) will beenrolled in the entire study (iethe entire study world-wide)

30

72B How many participants(including controls) will beenrolled at institutions coveredby this Research EthicsApproval (ie only at theinstitutions covered by thisapproval)

30

72C Of these how many arecontrols 0

72D Please enter anyadditional comments

73 Drug approvals Enter thegeneric name of anyinvestigational drug(s) not yetapproved or any marketeddrug(s) used outside of itsapproved indication

NA

74 Marketed Drugs Enter thename of any marketed drug(s)

NA

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used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

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amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

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ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

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files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

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Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

5222019 No Title

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on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

5222019 No Title

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will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

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112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 12: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

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was removed Blood samples will be marked with their study identifiersand analysed in Life labs for of serum 25-hydroxy vitaminD3 according to Standards Council of Canadarsquos GoodLaboratory Practice (GLP) principles and Good ClinicalPractice (GCP) The participant is responsible to collect tw stool samplesthe week after the three NB-UVB light exposures and storeit in the freezer The research coordinator will contact theparticipant when and where to pick up the stool samples orparticipant can drop them off at their own convenience atthe Skin Care Centre during on Monday Wednesday andFriday nights The stool samples that are collected from the participantwill be stored in the BCCHR in a -80C freezer in a lockedlab until all samples from all participants are collectedOnce all stool samples are collected they will be send offto the Stintzi Lab at the University of Ottawa for 16S rRNAsequencing The results will be analysed and stored on theBCCHR password-secured computer

6 Participant Information and Consent Process - Clinical Study [View Form]

61 Time to Participate Howmuch time will a participant beasked to dedicate to the projectbeyond that needed for normalcare

The first visit to sign the consent form and do the Skin typeassessment will take approximately 20 minutes The visitfor the first UVB exposure will take approx 20 minutes toreview the exposure methods The next two visits will take approximately 10-12 minuteseach The visits for the blood draws will take about 30 minutesdepending on the amount of waiting time of the Life Labslocation The total time the participant will spend to this study will be2 hours minutes

62 Time to Participate ndashNormalControl Participants Ifapplicable how much time will anormalcontrol volunteer beasked to dedicate to the project

Each participant will be treated similarly

63 RisksHarms Describe whatis known about the risks(harms) of the proposedresearch

The exposure to NB-UVB light will turn the skin slightly pinkfor 1-2 days NB-UVB is ultraviolet radiation and couldcause long term effects after excessive exposure like skinageing and skin cancer The exposure from this study isequivalent to 5 min sun exposure during a summerrsquos dayper visit and is unlikely to have any long-term effects Short-term side effects may include skin redness skin drynesstriggering of a cold sore All of these effects are minor and

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will resolve usually within a week In rare cases the skinmight turn red and gives a sun burn-like sensation In thiscase the sensation will fade away over the next days Theparticipant should contact the researcher in this case Although minimal there is a 05 risk of bleeding from theneedle site If this occurs the subject can be given apressure bandage The risks of blood draw also includespain andor discomfort bruising fainting andor lightheaded sensation and the rare possibility of infection

64 Benefits Describe anypotential benefits to theparticipant that could arise fromhis or her participation in theproposed research

Exposure to NB-UVB will produce vitamin D in your skinthat helps against seasonal affective disorder (SAD) and isimportant for your general health

65 Reimbursement Describeany reimbursement for expenses(eg meals parkingmedications) orpaymentsincentivesgifts-in-kind(eg honoraria gifts prizescredits) to be offered to theparticipants Provide full detailsof the amounts paymentschedules and value of gifts-in-kind

There is a $750 budget for this study for the 30 testparticipants Each participant will be given a $25 gift-certificate when the stool samples are collected and theparticipant is done with the study requirements

66 Obtaining Consent SpecifyA) who will explain the consentform B) who will consentparticipants C) Include details ofwhere the consent will beobtained and under whatcircumstances and D) therelationship of the personobtaining consent andparticipant

Once the potential participants agree to participate to thestudy by email the consent form will be explained in personby the research coordinator The research coordinator willbe able to answer all questions about possible concernsand about the procedure The consent form will bediscussed in person with the participant in an office settingin the Skin Care Center Once the participants sign theconsent form they agree to be a part of the study Theparticipants will get the stool collection kits at that time andwill come back for the further procedures one week laterThe participant is free to withdraw from the study at anygiven time for the duration of the study The physicians at the Skin Care Centre will go through theprocedures with the participant and is able to answer anyquestions regarding the UVB exposure

67A WaiverAlteration ofConsent If you are asking for awaiver or an alteration of therequirement for participantinformed consent please justifythe waiver or alteration andexplain how the study meets allthe criteria on the right Pleaseclick Guidance Notes on rightand ensure that you address

There will be no waiver

5222019 No Title

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each criteria individually Includethe corresponding letter (A B CD E) before each answer67B Waiver of Consent inIndividual Medical EmergenciesIf you are asking for a waiver oran alteration of the requirementfor participant informed consentin individual medicalemergencies please justify thewaiver or alteration and explainhow the study meets all thecriteria on the right Please clickGuidance Notes on right andensure that you address eachcriteria individually Include thecorresponding letter (A B C DE) before each answer

NA

68 Time to Consent How longafter being provided with detailedinformationconsent form aboutthe study will the participanthave to decide whether or not toparticipate Provide yourrationale for the amount of timegiven

Once the participant contacts the study by email theconsent form will be sent to them by email to read throughbefore the first meeting The research coordinator willdiscuss the contents of the consent form with theparticipant one week prior to the UVB light exposureprotocol Thus participants will have 1-2 weeks to reviewthe consent form before making a decision aboutparticipation

69 Capacity to Consent Willevery participant have thecapacity to give fully informedconsent on hisher own behalfPlease click Select to completethe question and view furtherdetails

Will theparticipanthave thecapacityto givefullyinformedconsent

Details ofthe natureof theincapacity

If notwhowillconsentonhisherbehalf

If not willheshe beable to giveassent toparticipate

If Yesexplainhowassentwill besought

Yes [Details]

610 Renewal of ConsentDescribe any situation in whichthe renewal of consent for thisresearch might be appropriateand how this would take place

There are no plans for renewal of consent No furthercontact is required after obtaining the samples All samplesand data will be de-identified on collection and cannot betracked back to the subjects

611 Provisions for ConsentWhat provisions are planned forparticipants or those consentingon a participants behalf to havespecial assistance if neededduring the consent process (egconsent forms in Braille or inlanguages other than English)

Participants have to be able bodied to be able to participatein order to receive the UVB exposure Subjects with nounderstanding of the English language will not beapproached for involvement in the study unless a translatoris present who can converse in the first language of thesubject

612 Restrictions on DisclosureDescribe any restrictions

There are no restrictions on disclosure of information

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regarding the disclosure ofinformation to researchparticipants (during or at the endof the study) that the sponsorhas placed on investigatorsincluding those related to thepublication of results Alsoindicate any plans forcommunicating study results toparticipants7 Number of Participants and Study Drugs - Clinical Study [View Form]

71 Multi-Centre Studies 71A Is this a multi-centre study(involves centres outside ofthose applied for under thisApproval)

no

If known please list the othersites below

71B Is this study beingsubmitted for ethical approval toany other Research EthicsBoard

DescriptionNo

If yes please provide the nameof the REB(s) and if availablecontact information

72 Number of Participants 72A How many participants(including controls) will beenrolled in the entire study (iethe entire study world-wide)

30

72B How many participants(including controls) will beenrolled at institutions coveredby this Research EthicsApproval (ie only at theinstitutions covered by thisapproval)

30

72C Of these how many arecontrols 0

72D Please enter anyadditional comments

73 Drug approvals Enter thegeneric name of anyinvestigational drug(s) not yetapproved or any marketeddrug(s) used outside of itsapproved indication

NA

74 Marketed Drugs Enter thename of any marketed drug(s)

NA

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used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

5222019 No Title

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amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

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ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

5222019 No Title

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files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

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Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2022

on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2122

will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2222

112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 13: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1222

will resolve usually within a week In rare cases the skinmight turn red and gives a sun burn-like sensation In thiscase the sensation will fade away over the next days Theparticipant should contact the researcher in this case Although minimal there is a 05 risk of bleeding from theneedle site If this occurs the subject can be given apressure bandage The risks of blood draw also includespain andor discomfort bruising fainting andor lightheaded sensation and the rare possibility of infection

64 Benefits Describe anypotential benefits to theparticipant that could arise fromhis or her participation in theproposed research

Exposure to NB-UVB will produce vitamin D in your skinthat helps against seasonal affective disorder (SAD) and isimportant for your general health

65 Reimbursement Describeany reimbursement for expenses(eg meals parkingmedications) orpaymentsincentivesgifts-in-kind(eg honoraria gifts prizescredits) to be offered to theparticipants Provide full detailsof the amounts paymentschedules and value of gifts-in-kind

There is a $750 budget for this study for the 30 testparticipants Each participant will be given a $25 gift-certificate when the stool samples are collected and theparticipant is done with the study requirements

66 Obtaining Consent SpecifyA) who will explain the consentform B) who will consentparticipants C) Include details ofwhere the consent will beobtained and under whatcircumstances and D) therelationship of the personobtaining consent andparticipant

Once the potential participants agree to participate to thestudy by email the consent form will be explained in personby the research coordinator The research coordinator willbe able to answer all questions about possible concernsand about the procedure The consent form will bediscussed in person with the participant in an office settingin the Skin Care Center Once the participants sign theconsent form they agree to be a part of the study Theparticipants will get the stool collection kits at that time andwill come back for the further procedures one week laterThe participant is free to withdraw from the study at anygiven time for the duration of the study The physicians at the Skin Care Centre will go through theprocedures with the participant and is able to answer anyquestions regarding the UVB exposure

67A WaiverAlteration ofConsent If you are asking for awaiver or an alteration of therequirement for participantinformed consent please justifythe waiver or alteration andexplain how the study meets allthe criteria on the right Pleaseclick Guidance Notes on rightand ensure that you address

There will be no waiver

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1322

each criteria individually Includethe corresponding letter (A B CD E) before each answer67B Waiver of Consent inIndividual Medical EmergenciesIf you are asking for a waiver oran alteration of the requirementfor participant informed consentin individual medicalemergencies please justify thewaiver or alteration and explainhow the study meets all thecriteria on the right Please clickGuidance Notes on right andensure that you address eachcriteria individually Include thecorresponding letter (A B C DE) before each answer

NA

68 Time to Consent How longafter being provided with detailedinformationconsent form aboutthe study will the participanthave to decide whether or not toparticipate Provide yourrationale for the amount of timegiven

Once the participant contacts the study by email theconsent form will be sent to them by email to read throughbefore the first meeting The research coordinator willdiscuss the contents of the consent form with theparticipant one week prior to the UVB light exposureprotocol Thus participants will have 1-2 weeks to reviewthe consent form before making a decision aboutparticipation

69 Capacity to Consent Willevery participant have thecapacity to give fully informedconsent on hisher own behalfPlease click Select to completethe question and view furtherdetails

Will theparticipanthave thecapacityto givefullyinformedconsent

Details ofthe natureof theincapacity

If notwhowillconsentonhisherbehalf

If not willheshe beable to giveassent toparticipate

If Yesexplainhowassentwill besought

Yes [Details]

610 Renewal of ConsentDescribe any situation in whichthe renewal of consent for thisresearch might be appropriateand how this would take place

There are no plans for renewal of consent No furthercontact is required after obtaining the samples All samplesand data will be de-identified on collection and cannot betracked back to the subjects

611 Provisions for ConsentWhat provisions are planned forparticipants or those consentingon a participants behalf to havespecial assistance if neededduring the consent process (egconsent forms in Braille or inlanguages other than English)

Participants have to be able bodied to be able to participatein order to receive the UVB exposure Subjects with nounderstanding of the English language will not beapproached for involvement in the study unless a translatoris present who can converse in the first language of thesubject

612 Restrictions on DisclosureDescribe any restrictions

There are no restrictions on disclosure of information

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regarding the disclosure ofinformation to researchparticipants (during or at the endof the study) that the sponsorhas placed on investigatorsincluding those related to thepublication of results Alsoindicate any plans forcommunicating study results toparticipants7 Number of Participants and Study Drugs - Clinical Study [View Form]

71 Multi-Centre Studies 71A Is this a multi-centre study(involves centres outside ofthose applied for under thisApproval)

no

If known please list the othersites below

71B Is this study beingsubmitted for ethical approval toany other Research EthicsBoard

DescriptionNo

If yes please provide the nameof the REB(s) and if availablecontact information

72 Number of Participants 72A How many participants(including controls) will beenrolled in the entire study (iethe entire study world-wide)

30

72B How many participants(including controls) will beenrolled at institutions coveredby this Research EthicsApproval (ie only at theinstitutions covered by thisapproval)

30

72C Of these how many arecontrols 0

72D Please enter anyadditional comments

73 Drug approvals Enter thegeneric name of anyinvestigational drug(s) not yetapproved or any marketeddrug(s) used outside of itsapproved indication

NA

74 Marketed Drugs Enter thename of any marketed drug(s)

NA

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used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

5222019 No Title

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amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

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ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

5222019 No Title

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files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

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Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2022

on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

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will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

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112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 14: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

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each criteria individually Includethe corresponding letter (A B CD E) before each answer67B Waiver of Consent inIndividual Medical EmergenciesIf you are asking for a waiver oran alteration of the requirementfor participant informed consentin individual medicalemergencies please justify thewaiver or alteration and explainhow the study meets all thecriteria on the right Please clickGuidance Notes on right andensure that you address eachcriteria individually Include thecorresponding letter (A B C DE) before each answer

NA

68 Time to Consent How longafter being provided with detailedinformationconsent form aboutthe study will the participanthave to decide whether or not toparticipate Provide yourrationale for the amount of timegiven

Once the participant contacts the study by email theconsent form will be sent to them by email to read throughbefore the first meeting The research coordinator willdiscuss the contents of the consent form with theparticipant one week prior to the UVB light exposureprotocol Thus participants will have 1-2 weeks to reviewthe consent form before making a decision aboutparticipation

69 Capacity to Consent Willevery participant have thecapacity to give fully informedconsent on hisher own behalfPlease click Select to completethe question and view furtherdetails

Will theparticipanthave thecapacityto givefullyinformedconsent

Details ofthe natureof theincapacity

If notwhowillconsentonhisherbehalf

If not willheshe beable to giveassent toparticipate

If Yesexplainhowassentwill besought

Yes [Details]

610 Renewal of ConsentDescribe any situation in whichthe renewal of consent for thisresearch might be appropriateand how this would take place

There are no plans for renewal of consent No furthercontact is required after obtaining the samples All samplesand data will be de-identified on collection and cannot betracked back to the subjects

611 Provisions for ConsentWhat provisions are planned forparticipants or those consentingon a participants behalf to havespecial assistance if neededduring the consent process (egconsent forms in Braille or inlanguages other than English)

Participants have to be able bodied to be able to participatein order to receive the UVB exposure Subjects with nounderstanding of the English language will not beapproached for involvement in the study unless a translatoris present who can converse in the first language of thesubject

612 Restrictions on DisclosureDescribe any restrictions

There are no restrictions on disclosure of information

5222019 No Title

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regarding the disclosure ofinformation to researchparticipants (during or at the endof the study) that the sponsorhas placed on investigatorsincluding those related to thepublication of results Alsoindicate any plans forcommunicating study results toparticipants7 Number of Participants and Study Drugs - Clinical Study [View Form]

71 Multi-Centre Studies 71A Is this a multi-centre study(involves centres outside ofthose applied for under thisApproval)

no

If known please list the othersites below

71B Is this study beingsubmitted for ethical approval toany other Research EthicsBoard

DescriptionNo

If yes please provide the nameof the REB(s) and if availablecontact information

72 Number of Participants 72A How many participants(including controls) will beenrolled in the entire study (iethe entire study world-wide)

30

72B How many participants(including controls) will beenrolled at institutions coveredby this Research EthicsApproval (ie only at theinstitutions covered by thisapproval)

30

72C Of these how many arecontrols 0

72D Please enter anyadditional comments

73 Drug approvals Enter thegeneric name of anyinvestigational drug(s) not yetapproved or any marketeddrug(s) used outside of itsapproved indication

NA

74 Marketed Drugs Enter thename of any marketed drug(s)

NA

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used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

5222019 No Title

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amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

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ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1822

files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

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Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2022

on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2122

will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2222

112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 15: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1422

regarding the disclosure ofinformation to researchparticipants (during or at the endof the study) that the sponsorhas placed on investigatorsincluding those related to thepublication of results Alsoindicate any plans forcommunicating study results toparticipants7 Number of Participants and Study Drugs - Clinical Study [View Form]

71 Multi-Centre Studies 71A Is this a multi-centre study(involves centres outside ofthose applied for under thisApproval)

no

If known please list the othersites below

71B Is this study beingsubmitted for ethical approval toany other Research EthicsBoard

DescriptionNo

If yes please provide the nameof the REB(s) and if availablecontact information

72 Number of Participants 72A How many participants(including controls) will beenrolled in the entire study (iethe entire study world-wide)

30

72B How many participants(including controls) will beenrolled at institutions coveredby this Research EthicsApproval (ie only at theinstitutions covered by thisapproval)

30

72C Of these how many arecontrols 0

72D Please enter anyadditional comments

73 Drug approvals Enter thegeneric name of anyinvestigational drug(s) not yetapproved or any marketeddrug(s) used outside of itsapproved indication

NA

74 Marketed Drugs Enter thename of any marketed drug(s)

NA

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1522

used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1622

amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1722

ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1822

files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1922

Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2022

on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2122

will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2222

112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 16: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1522

used within its approvedindication75 Natural Health Products Enter the name of any NaturalHealth Products used

NA

76 Experimental Devices Enter the name of any newinvestigational devices ormarketed devices used inexperimental mode that will beused outside of their approvedindication

A whole body stand-up photo-unit with Phillips UVB-NBfluorescent light bulbs as used in The Skin Care Center atVancouver General Hospital

77 PERs Enter the name ofany positron-emittingradiopharmaceuticals (PERs)

NA

78 Health Canada RegulatoryApprovals 78A Health CanadaRegulatory Approvals Is thisstudy a clinical trial orinvestigational test requiringHealth Canada regulatoryapproval (If this study does notrequire Health Canada approvalskip to 710)

no

78B If Yes check all thatapply from the list below

Description Regulatory Approval

78C Name thesponsorinstitutioninvestigatorresponsible for filing a ClinicalTrial Application (CTA) orInvestigational TestingAuthorization (ITA) with HealthCanada or Other

79 Details of Health CanadaRegulatory Approvals Ifregulatory approval from aHealth Canada directorate isrequired for this study yourcertificate of ethical approval willnot be released until theregulatory approval certificateapproval date and controlnumber are received by REBadministration Click Add toenter the name of the regulatoryagency the date of theapplication (if pending) or thedate of the approval and thecontrol number and the date ofapproval for either the initialapplication or subsequent

Name ofAgency

Date ofApproval

Date of PendingApplication

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1622

amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1722

ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1822

files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1922

Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2022

on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2122

will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2222

112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 17: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1622

amendments A copy of theapproval (NOL ITA NOA) mustalso be attached in question 91

Health Canada NOL ControlNumber

Health Canada NOL Control Number Date of Approval

710 Stem Cell Research Doesthis research fall within thecategories of pluripotent stemcell research that need to besubmitted to the CIHR Stem CellOversight Committee (SCOC)

no

711 Registration for Publicationof Clinical Trials 711A Doesthis clinical study fall within thedefinition stated on the right (inthe guidelines)

no

711B If Yes click Add to enterthe following information(Please note that registration byUBC ORS administrationrequires the prior ethicalapproval of the study In thatcase registration informationshould be added when itbecomes available)

Has it beenregistered

Indicate theAuthorized Registryused

Enter your ClinicalTrial uniqueidentifier

712 US RegulatoryRequirements 712A Is there arequirement for this research tocomply with United Statesregulations for research ethics

no

712B If yes please indicatewhether or not FDA(Investigational New Drug)number (drug studies) or an FDAInvestigational Device Exception(IDE) is required for the researchand provide documentation fromthe Sponsor or the FDA verifyingthe INDIDE number orexplaining the study exemptionstatus in Question 91C

8 Data Monitoring and Storage - Clinical Study [View Form]

81 Unblinding in an Emergency Describe the provisions made tobreak the code of a double-blindstudy in an emergency situationand indicate who has the code

NA

82 Data Monitoring Procedures Describe data monitoringprocedures while research is

NA

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1722

ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1822

files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1922

Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2022

on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2122

will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2222

112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 18: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1722

ongoing Include details ofplanned interim analyses Dataand Safety Monitoring Board orother monitoring systems

83 Study Stoppage Describethe circumstances under whichthe ENTIRE study could bestopped early Should this occurdescribe what provisions wouldbe put in place to ensure that theparticipants are fully informed ofthe reasons for stopping thestudy

Circumstances under which the entire study could bestopped would be very unlikely because the study includeshealthy participants and the photo therapy irradiancedosages have been established by dermatologists In casemore than 50 of the included participants will haveadverse side effects (lasting burning sensation and rednessof the skin) from the UVB exposure(s) the study will bestopped early The participants will be contacted by emailabout the situation and will be given the option to withdrawthe biological samples in case they are already collectedthe samples will be discarded in the bio hazard wastedisposal

84 Personal Identifiers 84A Describe how the identity of theparticipants will be protectedboth during and after theresearch study including howthe participants will be identifiedon data collection forms

The blood and stool samples will be marked with a studyidentifier (ABC) in executive letters to keep track whatsamples belong to which participant This identifier will alsobe written on a master list that will be kept separately fromthe other participant information The master list will bestored on a password protected computer in the BCCHRThere wont be any other personal details written on thesamples to protect the identity of the participant

84B Will any personal healthinformation or personalidentifiers be collected

no

If yes please describe whatpersonal identifying informationwill be collected and justify theneed for it to be collected

NA

85 Data Access and Storage 85A A) Explain who will haveaccess to the data at each stageof processing and analysis B)indicate whether a current list ofthe names of study personnel(including co-investigators andresearch staff) and theirdelegated tasks will bemaintained in the study file C) Ifa list will not be maintainedplease explain

A list of enrolled participants and their consent forms will beavailable to the research coordinator These files will bestored in a locked cabinet at the BC Childrens HospitalResearch Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) All data is de-identified by study identifier at the point ofsample collection The PI and students as listed on thisapplication will have access to the data during process andanalysis which will be stored on an analysis node which ishosted by the BC Childrens Hospital research institutesnetwork The code number ensures the data cannot betraced back to a subjects ID number by the PI co-PIs andstudents during processing and analysis A list of names of study personnel and their delegatedtasks will be maintained in the study file

85B Describe how the datawill be stored (eg computerized

The hard copy files from this study will be kept in a lockedfile cabinet in a locked office in the BC Childrens Hospital

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1822

files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1922

Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2022

on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2122

will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2222

112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 19: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1822

files hard copy video-recordingaudio recording personalelectronic device other)

Research Institute (Room 201 950 West 28th AveVancouver BC Canada V5Z 4H4) The de-identified data isgathered on paper clinical records forms and will betransferred to an electronic spreadsheet The data that will be collected from the microbiota analysiswill be stored and analysed on an analysis node which ishosted by the BC Childrens Hospital Research institutesnetwork The data can be accessed on a passwordprotected computer

85C Describe the safeguardsin place to protect theconfidentiality and security of thedata

The hard copy files will be kept in a facility that hasrestrictive access ID badge only for employees The filesare kept in a locked file cabinet in an locked office Theelectronic data will be saved on a password accessiblecomputer in the same room and is connected to a BCCHRhosted network that can not be accessed from outside theBCCHR

85D If any data or images areto be kept on the Web whatprecautions have you taken toprevent it from being copied

No data or images will be kept on the web

86 Disposition of Study Dataand Biospecmens 86A Describe A) what will happen tothe data at the end of the studyincluding B) how long the studydata will be retained C) whenand how the data will bedestroyed and D) what plansthere are for future use of thedata including E) who will haveaccess to the data in the futureand for what purpose If thisstudy involves the creation of aresearch database or registry forthe purpose of future researchplease refer to the Guidancenote linked on the right andprovide the requisite information

The raw and analysed data will be stored for 5 years on theBCCHR computing hard drive This data is only accessibleto people with a password to the computing node The datawill be removed from the computing node after passing 5years after publication of the study results Once the studyis completed the data will not be used for future research Hard copies of the consent forms will be kept in theBCCHR and is only accessible to the principle researchersThe hard copies will be destroyed by a shredder once the 5year term has ended

86B If applicable A) describewhat will happen to the studysamples biospecimens at theend of the study including B)how long the study samples willbe retained and C) where whenand how the samples will bedestroyed and D) what plansthere are for future use of thesamples including who will haveaccess to the sample in thefuture and for what purpose

The serum samples will be analysed by Life Labs inVancouver and will be discarded in the biological hazardwaste upon analysis The DNA from the stool samples willbe collected with a commercial kit and shipped to theUniversity of Ottawa for analysis The remainder of theDNA will be stored in a -80C freezer in the BCCHR untilquality of the sequencing analysis is confirmed DNAsamples will be discarded in the biological hazard wasteafterwards quality control of the sequencing run Neither ofthe labs get any personal information about theparticipants

87 Data Transfer to Other yes

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1922

Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2022

on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2122

will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2222

112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 20: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 1922

Institutions 87A Will data besent outside of the Institutionwhere it is being collected

87B If yes please describe A)the type of data to betransferred B) who the data willbe transferred to C) where thedata will be transferred and D)how the data will be sent

The stool samples will be send to the University of Ottawafor sequencing for bacterial composition analysis Thesamples will be send labelled with a study identifier to ourcollaborator in the Stintzi lab The data for further analysiswill be send back electronically and encrypted to theBCCHR researchers to store on password-protectedcomputers

88 Data Transfer to Institution 88A Will the researchers bereceiving data from other sites

no

88B If yes please describe A)the type of data to be receivedB) who the data will be receivedfrom C) where it will be receivedfrom and D) how the data will bereceived

89 Data Linkage 89A Willthe data be linked to any otherdata source (including abiorepository)

no

89B A) Identify the data setB) how the linkage will occurand C) explain howconfidentiality regarding theshared information will bepreserved

9 Documentation - Clinical Study [View Form]

91A Protocol Examples oftypes of protocols are listed onthe right Click Add to enter therequired information and attachthe documents

DocumentName VersionDate Password (if

applicable)Ethicsproposal 5 January 23

2018 [View]

91B Health Canada regulatoryapproval (receipt will beacknowledged)

Document Name Version Date Password (if applicable)

91C FDA IND or IDE letters(receipt will be acknowledged)

Document Name Version Date Password (if applicable)

92 Consent Forms Examplesof types of consent forms arelisted on the right Click Add toenter the required informationand attach the forms

DocumentName VersionDate Password (if

applicable)Consent FormUVB study 52 February

13 2018 [View]

93 Assent Forms Examples oftypes of assent forms are listed Document Name Version Date Password (if applicable)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2022

on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2122

will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2222

112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 21: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2022

on the right Click Add to enterthe required information andattach the forms94 InvestigatorBrochuresProduct Monographs Please click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

95 Advertisement to RecruitParticipants Examples arelisted on the right Click Add toenter the required informationand attach the documents

Document Name VersionDate Password (ifapplicable)

RecruitmentPoster UVB study 5 January

23 2018 [View]

facebook pageUVB study 1 May 15

2017 [View]

96 QuestionnaireQuestionnaire Cover LetterTests Interview Scripts etc Please attach each separatelyPlease click Add to enter therequired information and attachthe documents

Document Name Version Date Password (if applicable)

97 Letter of Initial Contact Please click Add to enter therequired information and attachthe forms

Document Name VersionDate Password (ifapplicable)

Letter of initial contactresearch participant 3

May42017

[View]

98 Data collection forms andOther Documents 98A Please attach Data collectionForms Chart extraction formsCRF or other documentsExamples of other types ofdocuments are listed on theright

DocumentName VersionDate Password (if

applicable)Response toREB review 3 May 12

2017 [View]

Fitzpartick scale 3 May 42017 [View]

UVBstudy peerreview 1 February

1 2017 [View]

98B If a Web site is part ofthis study enter the URL belowSince URLs may change overtime or become non-existentyou must also attach a copy ofthe documentation contained onthe web site to this section orprovide an explanation

10 Fee for Service - Clinical Study [View Form]

Please indicate which of thefollowing methods of payment

NA (Not funded by an Industry For-Profit Sponsors)

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2122

will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2222

112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 22: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2122

will be used for this applicationEnter information stating whenthe fee will be sent

11 UBC Childrens and Womens Research Ethics Board [View Form]

111 In order for a researchproject to be undertaken atCampW either an employee or amember of the medical staff (aslegally defined) needs to bedesignated as the PrincipalInvestigator This individual musthave actual responsibility withrespect to the project Select thePrincipal Investigator for theChildrens and Womens HealthCentre

Last Name First Name RankVallance Bruce A Associate Professor

112 Does the Childrens andWomens Principal Investigatorin question 11 (and 111 ifdifferent) have a UBC academicor clinical appointment

yes

Select Browse to attach thedeclaration form [View]

113 Select which hospitalform(s) are required for thisapplication

Not Applicable

If you selected OtherResourceService Utilizationplease specify below

11 Hospital Information - Vancouver Coastal Health [View Form]

111 Have you already receivedapproval from VCHA to conductthis study

no

If Yes please provide theVCHAVCHRI approval number(eg V06-0000)

112 A Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA and a UBC facultyappointment

no

112B Does the PrincipalInvestigator in question 11 havea medical appointment withVCHRIVCHA (but not a facultyappointment at UBC) or is thePrincipal Investigator anemployee of VCHA

no

Select the Browse button toattach the declaration form

[View]

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2222

112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf
Page 23: ACKNOWLEDGEMENT LETTER - ClinicalTrials.gov€¦ · 10th Avenue, Vancouver, BC V5Z 1L8 ACKNOWLEDGEMENT LETTER PRINCIPAL INVESTIGATOR: INSTITUTION / DEPARTMENT: UBC CREB NUMBER: Bruce

5222019 No Title

httpsriseubccarisesdCustomLayoutsPrintSmartFormsProject=comwebridgeentityEntity[OID[1C6BF05020B2C44C8478A94D0E13477C]] 2222

112 C Does the PrincipalInvestigator in question 11 havea UBC appointment

yes

Select the Site Investigator atVCHA if different from thePrincipal Investigator in question11

lastName firstNameDutz Jan P

113 Select the VCHA HealthService Delivery Area(s) that willbe involved in this study

Vancouver Acute (Vancouver Acute encompasses thefollowing sites Vancouver General Hospital UBC HospitalGF Strong Rehabilitation Centre Arthritis Research Centreof Canada Mary Pack Arthritis Centre DjavadMowafaghian Centre for Brain Health)

12 Save Application - Human Ethics [View Form]

Print Close

  • letter of completion H17-00303
  • H17-00303 version 3 PDFApdf