Navigating Research Ethics: RISe to the occasion

Heather Lovelace

November 1, 2012

TopicsOnline ResourcesThe research process and the ethics processWhy study approval?What study approval procedure involves

Health authorityUBC – the RISe online system

Behavioural vs Clinical Ethics committeesExpedited vs full reviewsKey deadlines

Online Resources

Research Modulehttp://dieteticsinternship.landfood.ubc.ca/dieteti

cs_internship_docsKey items for review (links available in research

module):Research project planning checklist (page 9-13)RISE guidance notesSample intern research guidance notesLocal/Health Authority Specific Research Ethics

Board Information (see project requirement/resources list)

Project Planning Checklist

Your best friend in research…keeping you organized!

The Research Process

Critical parts of the process

Research questionStudy DesignResearch ProposalEthics Review

Processes are simultaneous, require constant communication and include a feedback loop

You have a research questions and a study

design…

Now what?

Study Approval

Two levels of research ethics boards exits University (UBC…among others) Health Authority (7 in BC)

Applications are simultaneous processesWhy do separate ethics boards exist? Why do we require two separate ethics

proposals?

Health Authority vs UBC Approval

UBC/Shared GoalsTri-Council PolicyProtect subjects

PrivacyConfidentialityConsent

Avoid conflict of interest

Promote inclusiveness in research

Health AuthorityProtect subjects

As earlier, considers FIPPA (Free of Information in Protection of Privacy Act)

May be collaborative with or independent from UBC

Organizational ImpactUse of resources (human,

capital, IMIT, other)Liability

Management approvalSimultaneous Processes

Health Authority Approach Varies (see online resources for links)FHA*, IH*, NH*, VIHA*, VCH

UBC approval + Health Authority Specific Health Research Ethics Board (REB); *REB includes organizational requirements

NHA – may complete UBC or UNBC REB VCH – must complete VCHRI Approval to Conduct Research; this

addresses resource use and management approvals not captured elsewhere

Note: due to a multi-site project between PHSA-BCCA, NH and VIHA interns

PHSA, NH and VIHA interns will be using the PHSA-BCCA RISe process (so do not have to apply to local Health Authority Research Boards).

•Note: Information is specific to internship and UBC Ethics may/may not be included for post-graduate research.

Health Authority Approach Varies (see online resources for links)Providence Health and Provincial Health

Services Authority (BCCA/BCCW/CYMH)UBC ethics required + site specific ethics required

(Providence ethics/BCCA/BCCW/CYMH Ethics) UBC + site specific ethics all submitted via RISe

Organizational requirements: A Certificate of Ethical Approval issued by one

of the UBC Research Ethics Boards A site specific Health Care Institutional

Certificate of Final Approval - signed by the VP of Research & Academic Affairs.

•Note: Information is specific to internship and UBC Ethics may/may not be included for post-graduate research.

RISe – Research Information Serviceswww.rise.ubc.ca

RISe access

Researcher numbers Required for system access/first time you log onto RISeAssigned in the May professional practice course

• Check your email (inbox and TRASH)• No number? Contact DEC (Tamar)

Access using CWL“Sandbox” (mock site) is available

http://rise.ubc.ca/sandbox.aspResources to allow user to experience different RISe

Modules without affecting live data on the system. E.g., researchers including graduate and undergraduate

students are able to work on different research compliance protocols without affecting their live data.

Creating a New Ethics Application

Selecting a Research Ethics Board

Two Research Ethics Boards (REB) at UBC

Behavioural Involving interaction with

subjects (but no invasive procedures, e.g., taking blood)

Examples:SurveysFocus groupsCombination chart

review and patient interviews

Clinical Involving invasive

procedures Examples:

Drug trialsSurgical/medical

intervention trial

OR Anonymous retrospective

chart review

“BREB”

“CREB”

Separate processes; different ethics applications

Two Review Categories

ExpeditedBehavioural: Surveys,

questionnaires with competent individuals

Clinical: Anonymous chart reviews, reviews of databases

No specific deadline, can be submitted anytime

Full board ReviewAll othersSpecific deadlines to

coincide with monthly meetings

For each submission, researcher is asked whether project would qualify for expedited review, but research board decides

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We’ve selected a REB… Now what?

Completing the Ethics Proposal

Who does what and when?

Principal investigator (PI) Role of PI

Reviews proposal and presses “submit” for proposal and provisos For approval purposes, must be a UBC Faculty Member or

Staff memberTamar, most core-site coordinators, some research preceptorsNote: if Tamar is not the PI, must be listed as co-investigator in

order to access/review your RISe submission

Role of Research PreceptorsResponsibility is to be the PI or co-investigator and review all

documents before they are submitted

Who does what and when?

“Department Head” LFS Associate Dean Research Must approve all projects

Other investigators (aka YOU) Prepare submission (answer the questions) and prepare

attachments

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Ethics proposal: Answering the QuestionsConsider the type of question being askedQuestions are free standing risk

assessmentsassessment of the risk to participants and

researchersdetermine how you intend to deal with those

risks and if appropriate safeguards are in place

Ethics proposal: Answering the QuestionsExpect standards questions to focus on:

Researchers, relationships, funding sourcesResearch methods, including consent

processes, in/exclusion criteria, peer review, data management, disclosure, risk/benefit

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Key Areas Consent

free, ongoing, before study begins; undue inducement, coercion, incentives

Conflict of interest interpersonal, economic or financial relationships must

not jeopardize research integrityFairness

particular individuals or groups must not bear unfair burden of participating in or not benefiting from research Vulnerable groups: women, children, people who lack

capacity to consent

Research Method Is your proposed methodology adequate to identify an

answer?

HINT

Remember to review the guidance notes when answering

questions…

Submitting your Research Proposal as part of your Ethics Proposal

Read and refer to guidance notes frequentlyKnow the specific requirements for how to label

documents, including version numbers, use of headers/footers, page numberingUse their language whenever possible

• No detail is small enough to avoid escape!• E.g., provisos have been generated to deal with

attachments that did not have page numbers or appropriate version statements

Research proposals must be included in your submission

Sample Submissions

Sample Submission included in Research Module Planning ChecklistSample Survey SubmissionSample Chart Review Submission

We’re ready to submit…

What happens next?

Approvals vs. Provisos

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Provisos – concerns identified by reviewers

Issues of concern identified by Board reviewers…Ethical concerns

Research design puts participants at risk Consent is not free of undue inducement Incongruent dates (research that is set to begin before ethics

approval could be reasonably expected)Procedures not followed

Missing logos/letterhead or missing information from consent letter

Study proposal not attached Researchers did not indicate completion of TCPS

Must provide response and updated forms Be careful not to change ANYTHING other than what you have

been asked to address

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Important!

The first response to a proviso may not be accepted

Study cannot commence until approval certificates have been received from both UBC and health authority!

Ethics Submission Deadlines

See algorithmFirst Friday in December: RISe submission

completed and ready for Tamar to review no later than 9 AM. Tamar only has one afternoon to review and submit

for approval

RISe to the occasion: lessons learned

The early bird catches the wormIt’s never too early to start, but “too late”

happens quicklyKnow your deadlines and plan to beat them

Miss a deadline? Potentially delay your project by a month or more!

RISe to the occasion: lessons learned

Be systematicAs soon as you start developing your research proposal

Start your RISe submission Review appropriate RISe guidance notes Use their language, it can make the difference between an

approval and a proviso!

Review and understand your HA requirementsCheck your assumptions

Sometimes additional forms are required – e.g., approval to conduct research, financial sign-offs, manager signatures

May have to investigate to determine who should sign Don’t assume a manager is readily available to sign your forms

Health Authority Requirements

Common Question – who is the PI on Health Authority (HA) Forms?Refer to Research Module Appendix 2Site specificGenerally, PI must be an employee of the HAConsult REB instructions at your HAWork with research preceptor and Tamar if

there is confusion

Practical Advice for completing internship research on time

Meeting Your Target

Know your deadlinesWhen is your final presentation/paper due?What are the program expectations?What are your preceptors expectations?

Set timelinesUse the Internship Research Process Algorithm

Find “due dates” for health authority specific requirements

Communication

Ensure that preceptors know your timelinesSee handout on suggested timelines

Set regular meetingsMeet at regular intervalsAgree on schedule in advanceFace to face

Be clear Identify the issues/problems you need assistance withSeek outside advice

Know Your Resources

Internship Research Process AlgorithmWho can help you find where to start?

Clinical experts (RD’s with experience in your area of research)

Expert knowledgeHelps define the limits of your literature searchPerspective on the “issue” or questionMay be able to provide key references as a starting

point

Know Your Resources…

Research Module (multifunctional resource)resources and remindersLinks and guidance for ethics, research

process, including internship specific examples

Library Search Engines/Online journalsAccess to MedLine/PubMed via acute care

hospital; UBC online journals available from home

SummaryFormulate research Q

Prepare LOI and proposal (for approval by Research Advisory Committee)

Logon to RISE (UBC):

1. Set up project title

2. Provide required information

3. Attach files (consent letters, proposal, forms, etc.)

Response from research board

PI presses “submit”

Research preceptor and PI review proposal

Complete and submit health authority approval docs

LFS Associate Dean Research reviews and approves proposal

Waiting (check meeting dates for ethics board if full review)

Address any provisos (PI must press “submit”) Obtain approval

certificate(s)

Begin study!

And finally…

This is an occasion to RISe to…