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Research Ethics Consultation: The Central Role of the IRB

Research Ethics Consultation: The Central Role of the IRB. Norman Fost MD MPH Program in Bioethics University of Wisconsin – Madison SACHRP, July 20, 2010. “He who studies medicine without books sails an uncharted sea, but he who studies medicine without patients does not go to sea at all.”

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Research Ethics Consultation: The Central Role of the IRB

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  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. 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 Disclosures

  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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