The REB is your Friend

1. The REB is your Friend Ergo, the REB Chair must be your Best Friend

2. The REB is your Friend • Hard to know what to do with that title • In half an hour, I will not tell you everything about research ethics • What I shall do is to review a little of the lay or the land of research ethics, in terms of the law, regulation and ethics, struggle to keep you awake and leave you with two primary messages: • 1. Learn the rules as they apply to your research or know where to find them • 2. When in doubt, consult the REB.

3. Multiple facets of research oversight • Legal systems • Regulatory systems • Ethical concerns • Organizational issues – playing by local rules

4. Legal aspect • Legal issues: not much for us to say, other than investigators must obey • Most relevant law most commonly is applicable privacy legislation (generally PHIPA in Ontario)- issues arise often • Occasionally, other law is invoked, for example criminal law (fraud, insider trading)

5. Regulatory Jurisdictions: • Depending on the nature of the study, where it is done and who funds the investigators directly or indirectly and depending on the purpose of the study (i.e., product registration or not), up to five of the following sets of rules may apply in a given study: • -Tri-Council Policy • -Health Canada regulation (Division 5) • -‘Good Clinical Practice (‘GCP’) • -FDA regulation, US • -US ‘Common Rule’ (45CFR46)

6. Other regulation • Professional, e.g. College of Physicians and Surgeons (prohibition on physician advertising)

7. Jurisdictions • A series of largely non-communicative silos • Rules of one usually do not exactly correspond with the others but may not quite jive • PHIPA demands someone knowledgeable in privacy as part of REB, different from other rules; Natural Products Branch of Health Canada demands expertise in Natural Products

8. Beware entropic doom • Inexorable slide to more regulation and more bureaucracy- entropic • Why? Taking risk is a no-win situation • Bold is a 4-letter word • If as administrator you take a risk successfully, investigator and institution win. If you take a risk unsuccessfully, you take the hit. • It is, then, always easier to say ‘No’. Risk avoidance is a winning strategy. • A savvy administrator can stop the greatest investigator in her tracks!

9. Handling the ornery research administrator • An administrator who is uncertain of the rules will construe many initiatives as risky. Obligation of research ethics people is to know the rules well and stand to be corrected if need be. • Point #1 of this talk: Learn the rules as they apply to your research and/or know where to find them. This is important in order to argue your case if need be, perhaps to educate the REB.

10. Effective Research Administration • Facilitates research that conforms with external regulatory and legal standards (which can be highly innovative in terms of the science) • Tools are infrastructure and policies and SOPs that meet and exceed external standards • My initial response to new policies and procedures is negative, assuming that they represent more bureaucracy: they shouldn’t

11. You can’t fight City Hall • Some of the rules need to be updated or improved. • Difficult for individual investigators to protest (at least directly) – appear grumpy at best, always ineffectual • National (or larger) problems warranting national solutions • Appropriate for groupings of investigators

12. Fighting City Hall • e.g., management of adverse events and me: • Approached by one pharmaceutical company to lighten their burden • Organized national meeting May, 2009 under the aegis of the Canadian Association of REBs, CAREB,with involvement of the usual stakeholders (HC, Rx&D) • CAREB issued position paper last fall, got positive feedback from pharma and preliminary positive feedback from HC • A work in progress

13. An REB in every Institution • REBs or IRBs or RECs originated from the 1960s and 1970s, an era of one centre studies. The concept of an institutional REB fit. • We have moved to an era of big science with multi-disciplinary, multi-investigator, multi-institutional and multi-jurisdictional studies commonplace. • The ball is in the REB/regulator court to respond.

14. Centralization of Research Ethics Review • Recently, there have been major changes in opinions regarding central REBs from the FDA and NIH. Most recently, the draft revised TCPS is more tolerant and open to the concept. • You can take a horse to water but you cannot make it drink: institutions are uneasy. • Why? • Lost control (REBs) • Perceived risk despite evidence to the contrary (institutions) . • Some institutions forget their research mission .

15. Canadian initiatives regarding central ethics review • Multiple small, regional initiatives often involving multiple teaching hospitals under the aegis of a medical faculty • I have been involved with four practical initiatives • U of Ottawa teaching hospitals and U of O • Ontario Cancer Research Ethics Board: a larger, potentially generalizable initiative involving some 23 institutions in Ontario which do clinical trials in adults with cancer (institutions delegate to an independent REB supported by the Ontario Institute of Cancer Research) • Public Health preparedness for mass emergencies (institutions collaborate, streamlined process but institutions keep control) • Champlain Regional Infection Control Programme (in progress, low risk studies)

16. More action on the centralization front • And one high level series of discussions initiated by the President of CIHR • All to say that the times they are a changin’ because REB people like me are working on your behalf (secondarily on your behalf, primarily on behalf on participants and society) • OHREB tries to respond to needs of local investigators. • In the wings, thrombosis and who knows who else.

17. Ethics • At the end of the day, the basis of everything that is done in terms of oversight of human subjects research, including local rules, legal considerations, regulatory • Protection of human subjects (‘participants’) • Perhaps protection of the public weal • Promotion of good science

18. TCPS: Chapter Headings • Ethics Framework • Scope of Ethics Review • Free & Informed Consent • Inclusion in Research • Privacy & Confidentiality • Governance • Conflict of Interest • Multi-Jurisdictional Research • Research involving Aboriginal Peoples • Qualitative Research • Clinical Trials • Human Tissue • Human Genetic Research

19. TCPS: Basic principles • Concern for welfare • Respect for autonomy • Respect for the equal moral status of all humans

20. TCPS: Some key issues • (Conflict of Interest) • Consent • Risks- to rights (e.g., privacy, freedom of choice) • -physical

21. Research participation: an obligation? • Some suggest that citizens have an obligation to participate in some studies, in part because they incur a benefit from the outcome of research and quality assurance: a discussion in progress. • We’re not there yet, perhaps never will be. • An interesting thought.

22. The TCPS and you • Learning the TCPS is a rather large task for someone whose major focus is on a molecule or a disease or database research. • Which leads us to message #2: • When in doubt, consult the REB.

23. The REB is your Friend • Enlightened REBs recognize the societal benefit of good science and enlightened scientists recognize the societal benefit of research ethics oversight. • There is a lot of common ground. • Yes, the REB is your friend, both in guiding your research to be compliant with ethical norms and regulatory standards, as well as changing the rules to better serve you and your research.

24. Inflationary conclusion • In conclusion, remember the three rules: • 1. Learn the rules as they apply to your research or know where to find them • 2. When in doubt, consult the REB. • 3. Challenge authority

25. Links • www. ethics.gc.ca • www.ohri.ca/ohreb