WHAT IS A RESEARCH ETHICS BOARD? Karen Szala-Meneok, PhD

1. WHAT IS A RESEARCH ETHICS BOARD? Karen Szala-Meneok, PhD Senior Ethics Advisor, McMaster University November 3, 2011

2. Mandate of the REBs • To protect the rights, safety and well-being of any participant who takes part in research conducted by a faculty member post doctoral fellow, graduate student, undergraduate or staff member at or under the auspices of McMaster University. • No research involving humans may begin without written REB approval. November 3, 2011

3. How many REBs does McMaster have? • 1. McMaster Research Ethics Board: reviews human participant research conducted by McMaster Researchers from Business, Engineering, Humanities, Science, Social Science, Divinity College and other programs including certain Mohawk-McMaster hybrid programs • 2. Hamilton Health Sciences/Faculty of Health Sciences Research Ethics Board: A joint board that reviews research conducted by researchers affiliated with these two entities or research conducted at these sites. November 3, 2011

4. Establishment of McMaster’s REBs • The Research Ethics Boards (REBs) at McMaster are bodies that have been established by the President and report through the Office of the Vice President of Research and International Affairs. • In Addition, the Hamilton Health Sciences / Faculty of Health Sciences REB reports to the highest level of senior management at the Hamilton Health Sciences Corporation. November 3, 2011

5. Establishment of McMaster’s REBs The Tri-Council Policy Statement, Article 6.3 States: The institution grants the REB the mandate to review the ethical acceptability of research on behalf of the institution, including approving, rejecting, proposing modifications to, or terminating any proposed or ongoing research involving humans. November 3, 2011

6. But, why the “Tri-Council” Policy Statement? OR “Why do I have to follow the TCPS if: a) my research is unfunded or b) is funded by a source other than the Tri-Councils (i.e. SSHRC, NSERC or CIHR)?” November 3, 2011

7. McMaster Policy Statement for Research Involving Human Participants • McMaster University “endorses the ethical principles cited in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (1998), and any subsequent revisions thereto, and has mandated its Research Ethics Boards (REBs) to ensure that all research investigations involving human participants are in compliance with the Statement.” Excerpted from: McMaster Policy Statement for Research Involving Human Participants http://www.mcmaster.ca/ors/policies/humans.htm November 3, 2011

8. McMaster’s Policy continued… • “The University is committed, through its Research Ethics Boards, to assisting the research community in identifying and addressing ethical issues inherent in its research, recognizing that all members of the University share a commitment to maintaining the highest possible standards in research involving humans.” • TCPS stipulates that “institutions must respect the authority delegated to the REB.”TCPS Article 6.2 November 3, 2011

9. REB Guidance Documents & Regulations • Across Canada, REBs at universities, colleges, hospitals and other REBs have mandated the TCPS as the primary research ethics guidance document. • In addition, biomedical REBs have additional requirements to follow, such as Health Canada, Food and Drugs Act and Good Clinical Practice. • REBs (both behavioral and biomedical) must also be aware of federal, provincial and territorial privacy legislation regarding personal information. November 3, 2011

10. REB Composition & Structure Mandated by TCPS • Minimally…. • At least 5 female & male members. • At least 2 members from a broad range of McMaster’s research community who have experience with the type of research the particular REB reviews. • A community member with no affiliation to the institution. • A member knowledgeable in ethics. • For biomedical REBS a member with knowledge of the relevant law. • REB Membership expands as: • the types of research broaden • as the number of applications increase November 3, 2011

11. Composition and Structure of McMaster’s REBs McMaster Research Ethics Board • Chair model • 20+ members • Member knowledgeable in Ethics • Member knowledgeable in the law (additional) • Community members • Members with relevant research knowledge • Aboriginal community member Hamilton Health Sciences / Faculty of Health Sciences REB • Chair & vice chair model • 20+ members • Member knowledgeable in Ethics • Member knowledgeable in the law (required) • Community members Members with relevant research knowledge Member with statistics background November 3, 2011

12. REB Subcommittees Two examples of types of subcommittees McMaster’s REBs established to deal with the work of their boards in light of the notion of proportional review. • HHS/FHS has a Student Research Ethics Committee (SREC) for undergraduate and graduate research. • MREB has department/discipline specific SRECs to review minimal risk undergraduate research & course-based research (i.e. projects created to help students develop familiarity with methods). • HHS/FHS: Also has a Human Tissue Committee November 3, 2011

13. REB Workload • Each of McMaster’s REBs have hundreds of new applications submitted every year. Their numbers are growing. • Both REBs deal with thousands of pages of study documentation every year • Meet monthly or more frequently as required to review & clear protocols and conduct the work of the boards. • In addition to clearing these new studies they process, change requests, protocol deviations, and reports of serious adverse events for studies already in progress. November 3, 2011

14. REB WORKLOAD • Members read applications they are assigned & write reviews then go to the chairs. • Chairs lead monthly meetings (or more frequently for sub-committees), coordinate and communicate the initial results of the reviews to researchers and deal with subsequent communication to clear any remaining questions before clearance is granted. • Members & chairs work to stay current with trends and issues in research and research ethics and engage in continuing research ethics education. November 3, 2011

15. Key Roles and Responsibilities of the REB • To provide education to the McMaster research community about the ethical conduct of research with human participants. • To provide advice and guidance to researchers in the initial preparation of their protocols as well as after clearance has been obtained, should questions arise. November 3, 2011

16. Key Roles and Responsibilities of the REB • To provide initial ethical review of all research proposals prior to implementation. • To provide continuing ethical review of all cleared research over the life of the study. • To suspend or withdraw approval of any study which does not continue to meet ethical standards. November 3, 2011

17. Where does the work of the REB occur? • In face-to-face REB, SREC and other subcommittee meetings (meeting monthly or more frequently). • In one-on-one meetings/consultations with researchers, in monthly ethics drop-ins, by email & by telephone. • In education workshops, “Lunch & Learn” events, & during guest lectures in classrooms & other events. • In the administrative offices of the board that deals with the day to day work of the REBs. November 3, 2011

18. What about the “How” of Ethics Review…? I’ve taken you through the who, what, when, where, why of REBs. You’ll get to hear about the “how” at lunch time when you “Dine with the Chairs” . They’ll be able to answer that burning question….. “How does the research ethics board know my research is ethical?” November 3, 2011

19. The End… or is it just the beginning? Thank you for your kind attention… Dr. Karen Szala-Meneok Senior Ethics Advisor szalak@mcmaster.ca Ext. 26117 November 3, 2011