Navigating Research Ethics: RISe to the occasion Heather Lovelace November 1, 2012

Topics Online Resources The research process and the ethics process Why study approval? What study approval procedure involves  Health authority  UBC – the RISe online system Behavioural vs Clinical Ethics committees Expedited vs full reviews Key deadlines

Online Resources Research Module  s_internship_docs s_internship_docs  Key items for review (links available in research module): Research project planning checklist (page 9-13) RISE guidance notes Sample intern research guidance notes Local/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 question Study Design Research Proposal Ethics 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 processes  Why do separate ethics boards exist?  Why do we require two separate ethics proposals?

Health Authority vs UBC Approval UBC/Shared Goals Tri-Council Policy Protect subjects  Privacy  Confidentiality  Consent Avoid conflict of interest Promote inclusiveness in research Health Authority Protect subjects  As earlier, considers FIPPA (Free of Information in Protection of Privacy Act)  May be collaborative with or independent from UBC Organizational Impact  Use of resources (human, capital, IMIT, other)  Liability Management approval Simultaneous 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 Services

RISe access Researcher numbers Required for system access/first time you log onto RISe Assigned in the May professional practice course Check your (inbox and TRASH) No number? Contact DEC (Tamar) Access using CWL “Sandbox” (mock site) is available   Resources 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: Surveys Focus groups Combination chart review and patient interviews Clinical  Involving invasive procedures  Examples: Drug trials Surgical/medical intervention trial OR  Anonymous retrospective chart review “BREB” “CREB” Separate processes; different ethics applications

Two Review Categories Expedited  Behavioural: Surveys, questionnaires with competent individuals  Clinical: Anonymous chart reviews, reviews of databases  No specific deadline, can be submitted anytime Full board Review  All others  Specific deadlines to coincide with monthly meetings For each submission, researcher is asked whether project would qualify for expedited review, but research board decides

17 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 member Tamar, most core-site coordinators, some research preceptors Note: if Tamar is not the PI, must be listed as co-investigator in order to access/review your RISe submission Role of Research Preceptors Responsibility 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

20 Ethics proposal: Answering the Questions Consider the type of question being asked Questions are free standing risk assessments  assessment of the risk to participants and researchers  determine how you intend to deal with those risks and if appropriate safeguards are in place

Ethics proposal: Answering the Questions Expect standards questions to focus on:  Researchers, relationships, funding sources  Research methods, including consent processes, in/exclusion criteria, peer review, data management, disclosure, risk/benefit

22 Key Areas Consent  free, ongoing, before study begins; undue inducement, coercion, incentives Conflict of interest  interpersonal, economic or financial relationships must not jeopardize research integrity Fairness  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 frequently  Know the specific requirements for how to label documents, including version numbers, use of headers/footers, page numbering Use 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 Checklist  Sample Survey Submission  Sample Chart Review Submission

We’re ready to submit… What happens next? Approvals vs. Provisos

27 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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29 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 algorithm  First 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 worm  It’s never too early to start, but “too late” happens quickly  Know 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 systematic As 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 requirements Check 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 2  Site specific  Generally, PI must be an employee of the HA  Consult REB instructions at your HA  Work with research preceptor and Tamar if there is confusion

Practical Advice for completing internship research on time

Meeting Your Target Know your deadlines  When is your final presentation/paper due?  What are the program expectations?  What are your preceptors expectations? Set timelines  Use the Internship Research Process Algorithm Find “due dates” for health authority specific requirements

Communication Ensure that preceptors know your timelines  See handout on suggested timelines Set regular meetings  Meet at regular intervals  Agree on schedule in advance  Face to face Be clear  Identify the issues/problems you need assistance with  Seek outside advice

Know Your Resources Internship Research Process Algorithm Who can help you find where to start?  Clinical experts (RD’s with experience in your area of research) Expert knowledge  Helps define the limits of your literature search  Perspective on the “issue” or question  May be able to provide key references as a starting point

Know Your Resources… Research Module (multifunctional resource)  resources and reminders  Links and guidance for ethics, research process, including internship specific examples Library Search Engines/Online journals  Access to MedLine/PubMed via acute care hospital; UBC online journals available from home

Summary Formulate 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…