Form TD2: Research Ethics Protocol Form for Graduate Student Thesis, Dissertation, or Pilot ProjectResearch ethics protocols for theses, dissertations, and pilot projects are approved by the Faculty of Graduate Studies (FGS).

• SubmitpapercopiesoftherelevantformstoyourGraduateProgramforreviewandsignature.• GraduateProgramswillforwardformstoFGSThesis&DissertationCoordinator.• Allsubmissionsmustinclude:

º TD1(Thesis/DissertationProposalSubmission)Formsignedbythestudent,supervisor,andGraduateProgramDirector,

º thesis/dissertationproposal• Incasesrequiringpreliminaryresearch(e.g.,pilotproject),submitthepilotprojectresearchproposal

insteadofthethesis/dissertationproposal.º Informedconsentformº Ifapplicable,otherdocumentationrequiredforyourspecificresearchethicsprotocol

• Theaveragetimetoprocessminimalriskprotocolsisapproximately40workingdaysfromthedateofreceiptbyFGS.IN-COMPLETEORILLEGIBLEPROTOCOLSWILLBERETURNEDTOTHERESEARCHER,WHICHWILLDELAYTHEPROCESS.

• ResearchinvolvingAboriginal/IndigenousPeoples;thatismorethanminimalrisk;orthatinvolvesclinicaltrials,isap-provedbytheYorkUniversityHumanParticipantsReviewCommittee(HPRC).UseHPRCForm

• Researchethicsprotocolsforacourse,oraMajorResearchPaper(MRP),areapprovedbyyourGraduateProgram’sDelegat-edResearchEthicsCommittee.ConsultwithyourGraduateProgramforappropriateforms.

• Formoreinformationonresearchethicsrelatedmatters,pleasevisittheOREwebsite:http://research.info.yorku.ca/re-search-services/research-ethics/orFGSResearchEthics:http://gradstudies.yorku.ca/current-students/thesis-dissertation/research-ethics/

• Contact:ResearchOfficer(fgsro@yorku.ca)

Privacy: Personal information in connection with this form is collected under the authority of The York University Act, 1965 and will be used for educational, administrative and statistical purposes. If you have any questions about the collection, use and disclosure of personal information by York University, please contact: Faculty of Graduate Studies, 230 York Lanes, (416) 736-2100 x 55521.

Part A – General Information

A. Student Information

StudentName Date(mm/dd/yyyy)

E–mail Phone Studentnumber

Program Degree

Checkone:ThesisDissertationPilotProject

TitleofResearchProjectTitleofResearchProject

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Part A – General Information continued

A. Student Information continuedNameofSupervisor

IsthisarevisedversionofaprotocolpreviouslysubmittedtoFGSand/orHPRC?NoYes

Proposedstartdateforresearchinvolvinghumanparticipants(mm/dd/yyyy):

1. Is this research defined as:MinimalRisk?MorethanMinimalRisk?

IfMorethanMinimalRisk,doNOTusethisTD2form.SubmitHPRCProtocol.

TheHPRCusesthedefinitionofminimalriskasoutlinedintheSSHRC/NSERC/CIHRTri-CouncilPolicyStatement(TCPS)“EthicalConductforResearchinvolvingHumans”(December2014):“Ifpotentialsubjectscanreasonablybeexpectedtoregardtheprobabilityandmagnitudeofpossibleharmsimpliedbyparticipationintheresearchtobenogreaterthanthoseencounteredbythesubjectinthoseaspectsofhisorhereverydaylifethatrelatetotheresearchthentheresearchcanbere-gardedaswithintherangeofminimalrisk”(p.1.5).AnexpandedversionofthisdefinitionisavailablefromOREuponrequest.

NOTE:FullboardreviewisrequiredforALLresearchthatismorethanminimalrisk.AfullboardreviewrequiresameetingoftheHumanParticipantsReviewCommittee(HPRC)forthepurposesofprovidingfinalapprovalandwhich,asaconsequence,maytakelongertoreview.

2. Does this research involve clinical trials?NoYes

IfYes,doNOTusethisTD2form.SubmitHPRCProtocol.

3. Does your research involve Aboriginal/Indigenous Peoples? NoYes

The following questions may assist in determining whether your research involves Aboriginal/Indigenous Peoples:a.WilltheresearchbeconductedonAboriginalland(Canada;international)forwhichpermissionand/orapprovalfroman

authority(suchasbandcouncil,FirstNationsResearchEthicsBoard,etc.)mayberequired? No Yesb.WillrecruitmentcriteriaincludeAboriginalidentityaseitherafactorfortheentirestudyorforasubgroupofthestudy?

No Yesc. WilltheresearchseekinputfromparticipantsregardinganAboriginalPeoples’culturalheritage,artefacts,ortraditional

knowledge? No Yesd.WillresearchinwhichAboriginalidentityormembershipinanAboriginalcommunitybeusedasavariableforthepurpose

ofanalysisoftheresearchdata? No Yese.WillinterpretationofresearchresultsrefertoAboriginalcommunities,peoples,language,historyorculture?

No Yes

(Note:“Research”doesnotincludeliterarycriticismand/orhistory(excludingoralhistory)and/orprimarilytextualactivities)

Ifyouhaveanswered“yes”toanyoftheabovenotedquestions,thenyourresearchinvolvesAboriginal/IndigenousPeoples.IfYes,doNOTusethisTD2form.SubmitHPRCProtocol.ResearchersarerequiredtofamiliarizethemselveswiththeGuidelinesforResearchinvolvingAboriginalPeoplesandcompletetheChecklistforResearchers—ResearchInvolvingAboriginalPeoples.NotethatresearchinvolvingAboriginal/IndigenousPeopleswillfirstbereviewedbytheAboriginalResearchEthicsAdvisoryGroup(AREAG)priortobeingforwardedtotheHPRC.ResearchersmayreceiveinitialcommentsfromtheAREAGforwhicharesponsewillberequired.

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4. Is this research part of a faculty–led research project for which a faculty member is the Principal Investigator?NoYes

IfYes,doNOTusethisTD2form.Instead,pleaseattachTD4,StatementofRelationshipbetweenProposalandExistingApproved

Research/Facilities,aswellasacopyoftheHPRCApprovalCertificate.

5. Does this research involve animals or biohazards?No Yes

IfYes,doNOTusethisTD2form.Allstudentresearchinvolvinganimalsorbiohazardsmustbeunderfacultysupervision.PleaseattachTD4,StatementofRelationshipbetweenProposalandExistingApprovedResearch/Facilities,aswellasacopyoftheHPRCApprovalCertificate.

6. Are you conducting secondary data analysis?No Yes

Ifyes,pleasereviewtheSecondaryDataAnalysisGuidelinesandensurethatyoucompletesectionB.8below.

NOTE:SecondaryDataAnalysisisdescribedastheanalysisofdatacollectedforapurposeotherthanthatforwhichitwasoriginallycollectedinordertopursuearesearchinterestwhichisdistinctfromthatoftheoriginalwork.ResearchersareadvisedtoreviewtheSecondaryDataAnalysisGuidelinesforfurtherinformationonrequirementsrelatedtouseofsecondarydataforresearchpurposes.

7. Is any anticipated funding* for this project from any external (i.e., outside York) sources?NoYes

Ifyes,whatisthefundingagencyand/orprogram?

*Thedefinitionof“funded”doesnotincludefundingintheformofstudentOGSscholarships,SSHRCfellowships,NSERCscholar-ships,orCIHRawards.Theseawardsareintendedtosupportstudentsthroughtheirstudiesanddonotrequirereportsfromstudentsonthespecificresearchactivitiesconducted.Thedefinitionof“funded”doesapplytograntsawardedforspecificresearchprojects,whetherthoseprojectsbethestudent’sownresearchprojectsorresearchbeingconductedaspartofafacultymember’sfundedresearchproject.Typically,for“funded”research,grantingagenciesrequirereportsoftheresearchconducted.

8. Does this research involve another institution? Researchinvolvinganotherinstitution(suchasaschool,university,busi-ness,governmentagency)mayrequireadditionalethicsreviewandapprovalorpermissionsifusinginstitutionalresources(suchasinternallistservs,orconductinginterviewsonthepremisesoftheinstitution).NoYes

NOTE:Iftheresearchistobeconductedatasiterequiringethicsapprovaloradministrativepermission,pleaseincludealldraftinformedconsentforms/administrativepermissionrequests.Itistheresponsibilityoftheresearchertodeterminewhatothermeansofclearancearerequired,andtoobtainclearancepriortostartingtheproject.

a. Doanyoftheinstitution(s)/site(s)haveanethicsreviewboard? No Yes

If ‘Yes’, specify the institution(s)/site(s):

b. Doanyoftheinstitution(s)/site(s)requireadministrativepermission?No Yes

If ‘Yes’, specify the institution(s)/site(s) and provide a copy of the letter of permission:

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c. HasanyotherResearchEthicsBoard(REB)clearedthisproject? No Yes

If ‘Yes’, please submit the original application and provide a copy of the clearance letter.

Part B – Research Information1. Project DescriptionIn layperson’s terms, please provide a general and brief description of the research (e.g., hypotheses, goals and objectives, etc.).

2. ParticipantsState who the participant(s) will be:Describetheparticipantsthatwillberecruitedandaboutwhompersonalinformationwillbecollected(i.e.,numbers,age,specialcharacteristics,etc.).Describethesizeofthegroupfromwhichparticipantswillbere-cruitedandtheestimatednumberneededfortheresearch(minimum/maximum).Whereactiverecruitmentisrequired,pleasedescribeinclusionandexclusioncriteria.Wheretheresearchinvolvesextractionorcollectionofpersonalinformation,pleasedescribefromwhomtheinformationwillbeobtainedandwhatitwillinclude(include permission letters).

ThisstudywillbeusingaparticipantpoolPleaseindicatewhichparticipantpool(s):

URPPSchulichMarketingPoolSchoolofAdministrativeStudiesparticipantpoolKUREGlendonParticipantPoolOther:

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(Pleasecheckallthatapply)FinancialIn–kindDrawParticipantPoolBonusPointsOther:

b.Ifinducementsareprovided,pleaseprovidethesourceoffundingforthem:

5. Methodsa.Pleaseindicatealltheresearchmethodsthatapply:

ActionResearch EthnographyObservation SurveyDocumentaryFilmmaking FocusGroup Experimentallabstudy InterviewOral/Lifehistory HumanTissuesExperimentalbehaviouralstudy OnlineResearchOther:

b.Doanyofthemethodsinvolve: AudioRecording? NoYes PhotographicRecording?NoYes VideoRecording? NoYes

• Pleasenotethatexplicitconsentisrequiredtousethesemethodsofrecording.PleaseseeSection10,InformedConsentfordetails.

• Ifyouareusingrecordings,youwillberequiredtoaccountforhowtheywillbesafelystored,eventuallydestroyedorarchived,andhow,ifusedinresearchdissemination,confidentialitywillbemaintained.PleaseseeSection11,DataSecurityfordetails.

c. Whatwillberequiredoftheparticipant(s)?Clearlyspecifyinastep-by-stepoutlineexactlywhattheparticipant(s)willbeaskedtodoineachmethodology.Aseparateoutlineisrequiredforeachmethodology.Includethesettings,typesof

3. Recruitmenta.How will participants be recruited(e.g.,snowballtechnique,randomsampling,previouslyknowntointerviewer,telephonesolicitation,etc.)?

b. Will you be using any advertisements, flyers, posters, email scripts, social media postings, etc. for recruitment purpose?NoYes If‘Yes’,pleaseattachacopyofeachwithyourapplication.

4. Inducementsa. Will you be offering inducements to participate (e.g.,money,giftcertificates,academiccredit,etc.)?NoYesIfyes,pleaseelaborate:

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informationtobeinvolved,andhowdatawillbeanalyzed.Includedetailsaboutidentifyingparticipants,recruitment,proce-duresparticipantswillundertake,etc.Includecopiesofstudyinstruments.Pleasealsoincludetheestimatedtimecommit-mentrequiredofparticipantsforeachmethod.

d.Whatistheexperienceandtrainingoftheresearcherwiththiskindofresearch?Ifapplicable,pleaseprovideadescriptionofthesupervisor’ssupportforthisresearch.

6. RiskPleaseindicatepotentialrisksthattheparticipantsasindividualsoraspartofanidentifiablegrouporcommunitymightexperi-encebybeingpartofthisresearchproject:

a.Physicalrisks(includinganybodilycontact;administrationofanysubstance)? NoYesb.Psychological/emotionalrisks(feelinguncomfortable,embarrassed,anxious,upset)? NoYesc.Socialrisks(includingpossiblelossofstatus,privacyand/orreputation)? NoYesd.Datasecurity(i.e.,risktoparticipantfromdataexposure)? NoYese.Tiedtodeceptioninvolvedinthestudy?(SeeDEBRIEFINGsectionbelow) NoYesf.OTHER: NoYes

g.Noknownoranticipatedrisk:

Ifyouansweredyestoanyoftheabove,pleasedescribehoweachofthepotentialrisksdescribedabovewillbemanagedand/orminimized:

7. BenefitsWhat, if any, are the benefits to the participants? Or, No benefits

a. Discussanypotentialdirectbenefitstotheparticipantsfromtheirinvolvementintheproject;thesemightincludeeducationaboutresearchmethods,usefulknowledgegainedaboutself,etc.

b. Commentonthe(potential)benefitstothescientific/scholarlycommunityorsocietythatwouldjustifyinvolvementofparticipantsinthisstudy.

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8. Secondary Analysis of DataNOTE:SecondaryDataAnalysisisdescribedastheanalysisofdatainvolvinghumanparticipantscollectedforapurposeotherthanthatforwhichitwasoriginallycollectedinordertopursuearesearchinterestwhichisdistinctfromthatoftheoriginalwork.ResearchersareadvisedtoreviewtheSecondaryDataAnalysisGuidelinesforfurtherinformationonrequirementsrelatedtouseofsecondarydataforresearchpurposes.

a. Are you conducting Secondary Data Analysis? No Yes

If “No”, please GO TO QUESTION 9

If “yes” please answer the following questions:

i. Areyouusinganonymous data(datawhichneverincludedpersonalidentifiers)NoYesIf‘Yes,’pleaseprovideadescriptionoftheprovenanceofthedataset:

NOTE:Researchthatreliessolelyonsecondaryanalysisofanonymousdataisexemptfromethicsreview.

ii. Areyouusinganonymized data?(datawhichhasbeenstrippedofpersonalidentifiers;nopotentialfordatalinkage)

NoYesIf‘Yes,’pleaseprovideadescriptionoftheprovenanceofthedataset:

iii. Areyouusingidentifiable data:

NoYesIf‘Yes,’pleaseprovideadescriptionoftheprovenanceofthedataset:

b. Ifyouareconductingsecondaryanalysisusing identifiable data,pleaseaddressthefollowing:

i. Doyouplantolinkthisidentifiabledatatootherdatasets?

NoYesIf‘Yes’,pleasedescribe:

ii. Whattypeofidentifiabledatafromthisdatasetareyouplanningtoaccessanduse?

Studentrecords(pleasespecifyinthespacebelow)Healthrecords/clinic/officefiles(pleasespecifyinthespacebelow)Otherpersonalrecords(pleasespecifyinthespacebelow)

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iii. Whatpersonallyidentifiabledata(e.g.,name,studentnumber,telephonenumber,dateofbirth,etc.)fromthisdatasetdoyouplanonusinginyourresearch?Pleaseexplainwhyyouneedtocollectthisidentifiabledataandjustifywhyeachitemisrequiredtoconductyourresearch.

iv.Describethedetailsofanyagreementyouhave,orwillhave,inplacewiththeownerofthisdatatoallowyoutousethesedataforyourresearch.ATTACHMENTS: Submit a copy of any data use/access agreements.

v.Whenparticipantsfirstcontributedtheirdatatothisdataset,werethereanyknownpreferencesexpressedbyparticipantsatthattimeabouthowtheirinformationwouldbeusedinthefuture?

NoYesIf‘Yes’,pleaseexplain.

vi. Howwillyouobtainconsentfromtheparticipantswhoseidentifiabledatayouwillbeaccessing?Pleaseexplain.

Note: Consent of the participants is required for research involving secondary analysis of data that includes personalidentifiers. Waiver of consent may only be considered if researchers meet the additional criteria. Please consult theSecondaryDataAnalysisGuidelinesforfurtherinformation.

vii. Ifyoudonotintendtoseekconsentofparticipantsforuseofidentifiabledataforsecondaryanalysis,pleaseprovidearationaleastowhy:

9. Conflict of Interesta. Isthereapossibilityofanapparent,actual,orpotentialconflictofinterestonthepartofresearchers,theUniversity,or

sponsors?(e.g.,commercializationofresearchfindings,self-fundedresearch,etc.)

NoYesIf yes, please elaborate and outline how the potential or real conflict of interest will be addressed:

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b. Doanymembersoftheresearchteamhavemultipleroleswithpotentialparticipants(e.g.,researcherandtherapist,researcherandteacher,student/supervisor,teachingassistantandstudents,etc.)

NoYes If‘Yes’,pleasereviewResearchInvolvingInvestigators’Students

i) Describethenatureofthemultiplerolesbetweenresearcher(s)andanyparticipants

ii) Describehowthepotentialconflictofinterestthatwillemergeasaresultofthedualroleswillbeminimizedormanaged

c. Arethereanyrestrictionsregardingaccesstoordisclosureofinformation/results/dataatanypointduringthestudyincludingcompletionthatthefunder/sponsorhasplacedontheresearchers?(Theseincludecontrolsplacedbysponsors,fundingsources,advisoryorsteeringcommittees.)

NoYes

If‘Yes’,pleasedescribe:

10. Informed ConsentThis section pertains to issues around informed consent.

a. Istherearelationshipbetweenparticipantsandeitherofthefollowing:

PrincipalInvestigator: No YesPersonobtainingconsent(ifotherthanthePI): NoYesNotapplicable

If‘Yes’,whatstepswillbetakentoavoidtheperceptionofundueinfluenceinobtainingfreeandinformedconsent?

b. Ongoingconsentisrequirediftheresearchoccursovermultiplesessionsoroveranextendedperiodoftime.Doestheresearchoccurovermultipleoccasionsand/oroveranextendedperiodoftime(i.e.,beyond6months)?

NoYesIf‘Yes’,pleasedescribetheprocessofhowyouintendtoobtainongoingconsent?

c. Issubstituteconsentinvolved(e.g.,recruitingindividualsunder16;thosewithoutcapacitytoconsent)?

NoYesIf‘Yes’,pleaseelaborateonhowconsentandassentwillbeobtained.Pleaseattach1)SubstituteConsentFormforthe

parent/guardian,and2)AssentFormfortheparticipantwhichincludesallinformationrequiredintheconsentformbutiswritteninageappropriatelanguage.

d. Isdeceptioninvolved?Specifically,doyouintendtowithholdanyinformationfromand/orintentionallymisleadtheresearchparticipants?

NoYes

If‘No’,pleasegotoquestion“e”

If‘Yes’:i) Pleaseprovideadescriptionofthenatureofthedeceptionandwhetheritisfullorpartial.Pleaseprovidearationale

astowhydeception(inwholeorpart)isrequired:

ii) PleaseappendacopyofthedebriefingstatementThe debriefing statement needs to explain three elements:

(i) Why the experiment was developed and why the deception was necessary. (ii) What the current research says about the topic, which includes providing two references (text, article, on-line

reference) that the participants can reasonably access and understand (if you have an academic and non-academic population, you may need to provide more than one version of the debriefing statement or make sure that the references can be accessed by the least educated of the population).

(iii) Any additional resources that would be useful for the participant. Resources need to be appropriate and accessible for the participants. For example, if you are conducting a study on parenting, you could include community resources for parenting classes or recommendations for parenting guides. (source: Univ. Virginia, IRB)

Researchersmustre–obtainconsentfromtheparticipantsonc ethedebriefingstatementhasbeenprovided.ParticipantsshallbeprovidedwithandsigntheDebriefingConsentForm.

iii) Ifadebriefingstatementwillnotbeprovidedtotheparticipants,pleaseprovidearationaleastowhyastatementwillnotbeprovided:

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Inlightoftheabove,pleaseaddressthefollowingquestions:

a. Willthedatabetreatedasconfidential? No Yes

If“No”,pleaseprovidearationale:

b. Willtheparticipant(s)beanonymous? No YesIf“No”,pleaseprovidearationale:

11. Data SecurityPrivacy refers to an individual’s right to be free from intrusion or interference by others. It is a fundamental right in a free and democratic society. The ethical duty of confidentiality refers to the obligation of an individual or organization to safeguard entrusted information. Security refers to measures used to protect information. It includes physical, admin-istrative and technical safeguards.

Forafullerdescriptionofresearcherobligationssurroundingconfidentiality,privacyanddatasecurityissues,pleaseconsulttheData Security Guidelines for Research Involving Human Participants.

iv) Forstudiesthatarenotdeceptive,brieflydescribetheprocessandnatureofanyimmediatepost-studyinformationthatwillbeprovidedtoparticipantsandtherationaleforprovidingthisinformation(e.g.,counsellingortraumaresources,informationlinks,etc.):

e. Howwillinformedconsentbeobtained?(Pleasecheckallthatareapplicable):

InformedConsentForm.Pleaseattachdraftversion.AttachSubstituteConsentFormandAssentFormifapplicable.

VerbalConsent.Ifinformedconsentisbeingobtainedverbally,pleaseprovidearationaleregardingwhyverbalconsentmaybenecessaryandanInformedConsentFormisnotbeingused.Pleasenotethatverbalconsentispermissibleinonlyexceptionalcircumstanceswherewrittenconsentisnotfeasibleorinappropriate.PleaseattachdraftVerbalConsentScriptofwhatparticipantswillbeverballytold.

Onlineconsentform.Pleaseattachdraftversion.Ifonlineconsentisbeingobtained,pleaseindicatethewebsitewherethequestionnaire/surveywillbehosted:

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c.Describetheprocedurestobeusedtoensureanonymity/confidentialityofparticipants(whereapplicable)–or–theconfidentialityofdataduringtheconductofresearchanddisseminationofresults,suchasdataanonymization.

d.Pleasedescribehowyouplantostorehardcopydatasecurely,i.e.,consentformsandotherwrittenrecords.Notethatconsentformsmustbestoredfor2years. Lockedfilingcabinet Other

e.Pleasedescribehowyouplantostoreelectronicdatasecurely(suchasvideo/audiorecordingsanddocumentfiles)

Encryptedand/orpassword-protectedUSBkeys,laptopsand/orotherportableelectronicdatadevices SecureServer Other

f. Pleasedescribehowyouplantostoreotherformatsofdata(ifapplicable):

g.Ifyouplantodestroyresearchdata, •provideafirmdatebywhichthedatawillbedestroyed(mm/dd/yyyy):

•providedetailsoftheirfinaldisposal •forhardcopydata(e.g.,cross-cutshredder,etc.)

•forelectronicdata(e.g.,deletionandoverwritingofdrives;destructionofdrives;etc.)

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h.Ifyouplantoretaindataindefinitely,pleaseprovideajustification(e.g.,datauseforfutureresearch):

i. Describeanylimitationstoprotectingtheconfidentialityofparticipantswhetherduetothelaw,themethodsused,thenatureofthesamplepopulation,orotherreasons(e.g.,dutytoreport)thatyouareawareof.

j. Identifyallpartieswhowillhaveaccesstothedata.

PrimaryInvestigator/student Supervisor Other(pleasespecify):

k.Usesofthedata:Pleasedescribeallformsofoutputthatareanticipatedtoresultfromthisresearch(e.g.,presentations,writtenpapers,placingdatainanarchive,creativeworks,documentaryfilms,etc.).Describehowany

potentiallyidentifyinginformationwillbehandledineachformofoutput.

l. Subsequentuseofdata:Willthedatapotentiallybeusedforotherpurposesinthefuture(e.g.,teaching,futureanalysis,publishingofdataset,archivinginaninstitutionalrepository,etc.)?

NoYes

If‘No’,thedatawillbesolelyusedforthepurposesdescribedinthisapplicationandwillnotbeusedforotherpurposesinthefuture.

If‘Yes’,participantsmustbeinformedofthispossibilityduringtheconsentprocess.SubsequentuseofthedatafornewpurposesmayrequireadditionalreviewbytheREB.If‘Yes’,pleasedescribehowthedatawillbepreparedtomakeitsuitableforfutureuse(e.g.,anonymization,storage,archiving,etc.).Pleasedescribewhatfutureusesmightoccur(e.g.,usewithinthePI’sresearchgroup,transmissiontootherresearchers,publicationofthedataset,etc.).Pleaseidentifyanyknownrepositoriestowhichdatamaybesubmitted.(TheREBrecognizesthatallpotentialfutureusescannotbeanticipated,butdoesexpectthatdatawillbepreparedinamannerforfutureusesthatrespectstheconditionsunderwhichthedatawereoriginallycollected.)

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12. Additional InformationIs there any additional information that you would like to add that may assist the HPRC in reviewing your protocol?

Part C – DeclarationsStudent Declaration

Iherebycertifythatallinformationonthisformandallstatementsintheattacheddocumentationarecorrectandcomplete.Ihaveexaminedtheguidelinesandprinciplesdetailedabove,andtheSenatePolicyforResearchInvolvingHumanParticipants,andaffirmthat,tothebestofmyknowledge,thisresearchconformsthereto.IaffirmthatIhaveinformedallmembersofmyresearchteamoftheirresponsibilitiesasitspeakstotheconductofresearchinvolvinghumanparticipantsandasoutlinedintheSenatePolicyforResearchInvolvingHumanParticipants.Ihaveadvisedallresearchteammembersthatallhumanpar-ticipantsintheresearchmusthavesignedawrittenconsentformorhaveprovidedoralconsentfortheirparticipationintheresearch.IherebyundertaketonotifytheHumanParticipantsReviewCommitteeviatheOfficeofResearchEthics(HPRC)ifImakechangesinvolvingtheuseofhumanparticipantsonthisprojectandsubmittherequireddocuments(e.g.Amendmentrequest)toHPRCforreviewandapproval;ifthesechangesarenotminor,myresearchproposalmayberequiredtoundergoafurtherethicsreview.Iunderstandthatanymisrepresentationintheproposalorattacheddocumenta-tionmayleadtoachargeofbreachofacademichonesty.Inthecaseofanadverse/unanticipatedevent,IwillnotifyHPRC.IalsounderstandthatImustretainConsentFormsfortwoyearsfollowingthecompletionoftheresearch.IwillalsonotifyHPRCifanyunforeseenrisksnotspecifiedintheresearchproposalappear.Insuchacase,thestudywillbesuspendedpend-ingclarification.

SignatureofStudent Date(mm/dd/yyyy)

Supervisor Declaration

Iherebycertifythatallinformationonthisformandallstatementsintheattacheddocumentationarecorrectandcomplete.Ihaveadvisedthestudentthatallhumanparticipantsintheresearchmusthavesignedawrittenconsentformorhaveprovidedoralconsentfortheirparticipationintheresearch.IhaveadvisedthestudentthattheHumanParticipantsReviewCommitteeviatheOfficeofResearchEthics(HPRC)willbeadvisedofanychangesinresearchmethodologyoranyincreasedanticipatedriskstohumanparticipantsandthatafurtherethicsreviewandapprovalisrequiredasaresultofsuchchanges.IhaveadvisedthestudentthatConsentFormsmustberetainedfortwoyearsfollowingthecompletionoftheresearch.

Signatureofsupervisor(ofThesis/Dissertation) Date(mm/dd/yyyy)

Section to insert Digital Signatures (if applicable):

ElectronicSignatureofPrincipalInvestigator(PI) Date(mm/dd/yyyy)

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Document ChecklistPleaseattachthefollowingitems,ifapplicable,toTD2,GraduateStudentHumanParticipantsResearchProtocol.

Incomplete forms will not be accepted for review.

1 All TD2 forms must have the following attached: a. InformedConsentForm(s) b. TCPSCertificate2 Other Consent Documents (if applicable):

SubstituteConsentform(Parental/Guardianconsent)—requiredifyourresearchparticipantsareunder16yearsofageorwithoutcapacitytoconsent

AssentForm—requiredifyourresearchinvolvessubstituteconsent

VerbalConsentScript—requiredifyouplantoseekverbalconsentforanyoftheresearchparticipants

On–lineConsentScript—requiredifparticipantsareaskedtoconsentonline

3 External permission and approvals (if applicable):

DecisionsNeededFromOtherREBBoards—requiredifyourresearchrequiresethicsapprovalfromaninstitutionotherthanYorkUniversityExternalREBapprovalrequired—certificateattached

Externalinstitutionalpermissionrequired—documentationprovided

Internalinstitutionalpermission/approvalrequired(e.g.,OIPA)—documentationprovided

Medicaldirective

ResearchAgreement(s)—appendallcopiesDatause/accessagreements(foruseinsecondarydataanalysis)

4 Test Instruments (if applicable):

QuestionnairesandTestInstruments

Draftinterviewquestions,focusgroupquestions

5 Recruitment (if applicable):

RecruitmentMaterials:Posters,Letters,ParticipantPoolAdvertisement,etc.

6 Debriefing (if applicable):

DebriefingLetter—requiredifyourresearchinvolvesdeception(seeSection10,InformedConsentfordetails)

DebriefingConsentDocument—requiredfollowingadministrationofdebriefingstatement(ifyourresearchinvolvesdeception)

7 Other (if applicable):

ProvenanceofAnonymousData

ResearchTeamMemberConfidentialityAgreement

ParticipantImagesInformedConsentAddendum

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