The purpose and process of
formal ethical review
International Workshop of Ethics Review and
Clinical Trial Transparency, Chengdu.
28th -30th June 2009
Adapted and Adopted from a presentation
by Prof. Dan Wikler given at a WHO- ERC
Workshop
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Ethics Review Committee | 28th -30th June 2009, Chengdu
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
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Ethics Review Committee | 28th -30th June 2009, Chengdu
Philosophical Foundation
 “Moral Point of View”
 “Ideal Ethical Observer”
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Informed
Impartial / Disinterested
Calm
Wise
Benevolent
Ethics Review Committee | 28th -30th June 2009, Chengdu
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)
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Ethics Review Committee | 28th -30th June 2009, Chengdu
How Do ERCs Serve?
 Deterrence
 Educating scientists and the public
 Improving design and ethics
 Social contract: builds support for medical science
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Ethics Review Committee | 28th -30th June 2009, Chengdu
ERC Issues
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Ethics Review Committee | 28th -30th June 2009, Chengdu
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
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Ethics Review Committee | 28th -30th June 2009, Chengdu
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?
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Ethics Review Committee | 28th -30th June 2009, Chengdu
ERC Independence
 Conflict of interest for committee members
 Freedom from pressures:
– Economic
– Institutional
– Political
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Ethics Review Committee | 28th -30th June 2009, Chengdu
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
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Ethics Review Committee | 28th -30th June 2009, Chengdu
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)
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Ethics Review Committee | 28th -30th June 2009, Chengdu
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
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Ethics Review Committee | 28th -30th June 2009, Chengdu
ERC Staff
 Staff functions vs. Committee functions
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Preparing protocols
Ensuring routine compliance
Preparing initial reports
Posing questions
 Number and training of staff
 Funding staff
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Ethics Review Committee | 28th -30th June 2009, Chengdu
Accountability, Accreditation
 No international regulatory agency
 Process criteria vs. outcome criteria
 National accreditation:
– Drug regulatory agencies (FDA)
– Ethics oversight agencies (OHRP)
– China?
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Ethics Review Committee | 28th -30th June 2009, Chengdu
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?
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Ethics Review Committee | 28th -30th June 2009, Chengdu
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
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Ethics Review Committee | 28th -30th June 2009, Chengdu