1. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 1 |1 | The purpose and process of formal ethical review International Workshop of Ethics Review and Clinical Trial Transparency, Chengdu. 28 th -30 th June 2009 Adapted and Adopted from a presentation by Prof. Dan Wikler given at a WHO- ERC Workshop

2. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 2 |2 | Why an ethics committee? Ethical review committees are not recommended by the Nuremberg Tribunal or by the original Declaration of Helsinki Dr. Henry Beecher, Harvard Medical School, author of influential NEJM exposé, opposed ERCs ERCs were proposed by the US National Commission for the Protection of Human Subjects in the 1970s

3. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 3 |3 | Philosophical Foundation “Moral Point of View” “Ideal Ethical Observer” –Informed –Impartial / Disinterested –Calm –Wise –Benevolent

4. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 4 |4 | What is ethical review for? Protect Human Subjects? –Individual over group? Treat Human Subjects Fairly? –No risk-taking without consent and without scientific justification Treat Human Subjects Equally? –No discrimination (racism, bias)

5. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 5 |5 | How Do ERCs Serve? Deterrence Educating scientists and the public Improving design and ethics Social contract: builds support for medical science

6. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 6 |6 | ERC Issues

7. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 7 |7 | Procedure vs Substance Procedure versus substance: –Is a “checklist” sufficient? Guidelines, Principles, Interpretation –Is the ERC supposed to have a mind of its own? ERC functions requiring substantive judgment –weighing risk to subject against benefits to future patients –judging the extent of risk and the amount of possible harm –deciding whose interests require protection

8. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 8 |8 | Science vs Ethics Should ERCS review scientific design? –The “statistician-ethicist” Can bad science be ethical research? –Balancing risk and benefits –When there is no risk: the “0-0” Rule?

9. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 9 |9 | ERC Independence Conflict of interest for committee members Freedom from pressures: –Economic –Institutional –Political

10. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 10 | Addressing Conflict of Interest Institutional –Support –Co-sponsorship, co-investment –Subversion and control Personal –Regulation and prevention –Disclosure to authorities –Disclosure to research subjects & patients

11. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 11 | ERC Sins Bottlenecks: unreasonable delays Overreaching: broad definition of “research” Wasting committee time: focus should be on issues requiring discussion Wasting researcher time: repeat revisions, nit-picking Deficits in expertise (genetics, epi)

12. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 12 | Challenges to the IRB system Little continuing review –“Has any patient died?” –Few site visits; no monitoring of consent –Little communication between IRB and DSMB or FDA Superficial Review –Too many protocols, too quickly, insufficient expertise No self-assessment of performance Conflict of interest Little support for function

13. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 13 | ERC Staff Staff functions vs. Committee functions –Preparing protocols –Ensuring routine compliance –Preparing initial reports –Posing questions Number and training of staff Funding staff

14. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 14 | Accountability, Accreditation No international regulatory agency Process criteria vs. outcome criteria National accreditation: –Drug regulatory agencies (FDA) –Ethics oversight agencies (OHRP) –China?

15. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 15 | Who Judges Performance? “The Golden Rule” –He who provides the gold, sets the rules Learning from the FDA and OHRP –Is the American way the best way? Problems of resource limitation Problems of sovereignty An international alternative?

16. Ethics Review Committee | 28 th -30 th June 2009, Chengdu 16 | ERC Management: Resources IRB Guidebook Http://www.ohrp/osophs.dhhs.gov Operational Guidelines for Ethics Committees that Review Biomedical Research (TDR, WHO) Research Ethics Committees – Basic concepts for capacity building Institute of Medicine (NAS) accreditation –http://www.iom.edu/hrrp –http://nap.edu/openbook/0309073286/html