Ethical Review Committees

1
Ethical Review Committees

• Based on a presentation by Prof.Daniel Wikler,
  World Health Organization and University of
  Wisconsin, Madison

2
ERC Role in Research Regulation

• National regulations may or may not provide a
  role for ERCs
• ERC approval may be required for some funding
  sources and not others
• ERCS may be institutional or independent even
  for-profit
• Institutional review may present conflict of
  Interest

3
What Purpose Do ERCs Serve?

• Deterrence
• Educating scientists and the public
• Improving design and ethics
• Social contract builds support for medical
  science

4
Science vs Ethics

• Should ERCs review scientific design?
• The statistician-ethicist
• Can bad science be ethical research?
• Balancing risk and benefits

5
Procedure vs. Substance

• Guidelines, Principles, Interpretation
• 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

6
ERC Staff

• Staff functions vs. Committee functions
• Preparing protocols
• Ensuring routine compliance
• Preparing initial reports
• Posing questions
• Number and training of staff
• Funding staff

7
ERC Independence

• Conflict of interest for committee members
• Freedom from pressures
• Economic
• Institutional
• Political

8
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

9
Challenges to the ERC system

• Little continuing review
• Have any patients died?
• Few site visits no monitoring of consent
• Little communication between ERC/IRB and DSMB or
  FDA
• Superficial Review
• Too many protocols, too quickly, insufficient
  expertise

10
Challenges to the ERC system (continued)

• No self-assessment of performance
• Conflict of interest
• Deficits in expertise (genetics, epidemiology,
  etc.)

11
Capacity Development

• No survey exists of existing capacity
• Technical assistance
• NIH, NIH-sponsored programs
• WHO
• Tropical Diseases Research
• Research in Human Reproduction
• UNAIDS
• Evidence and Information for Policy

12
Accountability, Accreditation

• No international regulatory agency
• Process criteria vs. outcome criteria
• National accreditation
• Drug regulatory agencies (FDA)
• Ethics oversight agencies (OHRP)

13
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?

14
ERC Management Resources

• U.S. Office for Human Research Protections (OHRP)
• http//www.ohrp/osophs.dhhs.gov
• Operational Guidelines for Ethics Committees that
  Review Biomedical Research (TDR, WHO)

15
Program on Ethical Issues in International Health
Research

• http//www.hsph.harvard.edu/bioethics
• Provides
• Information source
• Linkages to outside resources
• Discussion forum