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Research Ethics Consultation: The Central Role of the IRB Norman Fost MD MPH Program in Bioethics University of Wisconsin – Madison SACHRP, July 20, 2010.

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Presentation on theme: "Research Ethics Consultation: The Central Role of the IRB Norman Fost MD MPH Program in Bioethics University of Wisconsin – Madison SACHRP, July 20, 2010."— Presentation transcript:

1 Research Ethics Consultation: The Central Role of the IRB Norman Fost MD MPH Program in Bioethics University of Wisconsin – Madison SACHRP, July 20, 2010

2  “He who studies medicine without books sails an uncharted sea, but he who studies medicine without patients does not go to sea at all.”  William Osler  “I taught medicine on the wards.”   Osler’s requested epitaph.

3 Disclosures  IRB chair for 31 years  Co-PI of large controversial trial –Defendant in lawsuit  Data Monitoring Committees (Honoraria)  Research participant  Chair of FDA regulatory committee  Thesis: –These roles were all mutually enhancing. –IRB experience was the most important in developing skills as a research ethics consultant »Reviewed > 15,000 protocols

4 General comments  Decisions in research ethics consultation are likely to be more far-reaching than clinic ethical consultations –Affect many subjects/future patients –Affects careers of PI and team; institution »Directly and ripple effects –Larger financial implications  More complex: science, statistics, larger cast of characters, powerful competing interests

5 Ideal Ethical Observer (Firth)  Omniscient –Knows relevant available facts  Omnipercipient –Vividly imagine feelings of all involved  Disinterested –No vested interest in outcome  Dispassionate –Not overwhelmed with emotion  Consistent –Similar cases decided similarly

6 Ideal Research Ethics Consultant  Deep understanding of relevant knowledge: ethics, law, sociology, religion, medicine, design etc.  Research experience: PI and participant  Clinical experience –Warner Wolf effect: pure studio sportscaster –Nephrologist: “What a kidney might look like”  Clinical ethics consultation experience  IRB experience  DMC experience  Grant reviewing experience (NIH)  Regulatory experience (FDA)  Industry experience  Policy experience

7 Advantages of IRB as focal point  Collaborative, multidisciplinary –Collectively emulates Ideal Observer –Independent scientific, statistical expertise critical  Final tollgate  Review all protocols –They don’t know what they don’t know –The call you don’t get is the most important  Educate IRB members  Better able to advise PI’s –Increase scientific knowledge –Know how (part of) the real world works  Increased visibility  more consults  Can affect institutional norms/policies –E.g., Who has access to medical records for research

8 Criticisms of IRB service  Dual loyalty: True, but also –True of all IRB members –True of all institutional ethicists –True of all committee members  Excessive work/glory chaff/wheat ratio –Off load the chaff »Decrease regulatory burden  Fost/Levine: JAMA Nov 14, 2007  Obsession with documentation of compliance; protection of institution; –Resume mission of ethics review »UW Staff model IRB

9 Staff model IRB  Staff reviews protocols for regulatory compliance –Or, Subcommittee of IRB members  IRB meeting is to discuss/decide difficult /complex issues  Continuing review by subcommittee –Expedited review –Problems brought to full IRB  4-5 members with expertise in research ethics/law

10 Examples  Waived consent for emergency research –RCT: 3 steroid regimens, all in common use –PI did not ask for ethics consultation –Traditional IRB would have rejected it based on FDA requirement that test article must be life-saving –Led to article  consortium  FDA conference  change in rules

11 Examples  Jamie Thomson: Human embryonic stem cells from residual IVF embryos –Did ask for REC  Development of UW Guidelines --> AAAS, NAS guidelines –What if he hadn’t? »Arguably not human subjects research  Non-identifiable residual tissue »Public reaction was generally supportive, in part because of detailed guidelines

12 Summary  Ethicist should not be a “stranger at the bedside” or the benchside, but part of the treatment/research enterprise  IRB collectively can emulate the qualities of an ideal ethical observer  One ethicist can not be an ideal observer, but can enhance his/her skills by experience in multiple arenas, outside of the conference room.

13 Examples  Jamie Thomson’s stem cell protocol –Asked for consultation 5 years before first paper because of regulatory and ethical perspective –Required extensive education/integration of IRB, Biotechnology Advisory Committee, and WARF (patent holder) –Frequent changes over next 15 years –Guidelines became template for NAS/ISSCR guidelines

14 Example  Wisconsin CF Newborn Screening Study –Unique ethical and legal issues (appealed to US Supreme Court) –Ethics consultant (NF) became co-PI –1-2 years for approval from 4 IRBs, CF Foundation, NIH, University committee, outside critics –Communication with IRB(s) critical


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