1. 1 The Perspective of a Local IRB Challenges related to human subjects research protections in the context of disasters Presented to SCAHRP October 30, 2007 By Joseph L. Breault

2. 2 My Background Joseph L. Breault, New Orleans Metro Area, LA ― MD, Tulane ― Family Medicine RPSM, Montefiore (NYC) ― ScD (Health Systems Management) Tulane ― MPHTM (Tropical Medicine) Tulane ― CIP (Certified IRB Professional) Chair, Ochsner Institutional Review Boards from 3/2002 ― 7 hospitals, 25 neighborhood health centers, ~8000 employees, ~700 research studies, >600 physicians, >375 residents/fellows, >400 allied health students ― Near the center of Katrina, fully operational throughout

3. 3 And a Katrina disaster victim myself…

4. 4 Key Points 1. IRBs are here to protect human subjects Urgency to do research in these vulnerable disaster populations should not be reducing human subject protections 2. Local context issues Sensitivity to local culture of the subjects Role of local researcher involvement 3. Local Institutions have FWA & other responsibilities Engagement in Research via employees or data

5. 5 1. IRBs are here to protect human subjects The local IRB system grew out of a long series of research abuses that resulted in a public outcry, the Belmont Report, the Common Rule and other IRB regulations. IRBs are here to protect people. Many want to waive IRB and consent rules to speed up their research. Just because you may have federal power to do it, does not make it the right solution! Find ways for IRBs to work efficiently in disasters – e.g., we have special IRB meetings for turnaround within a few days in urgent settings. There are central IRBs (e.g., CDC IRB) that many institutions could agree to put on their FWA to avoid multiple IRB approvals, etc.

6. 6 The Background for Local Context issues LOCAL CONTEXT August 27, 1998 [Updated July 21, 2000] TO: Division of Human Subject Protections, OPRR FROM: Director, Division of Human Subject Protections, OPRR SUBJECT: IRB Knowledge of Local Research Context Department of Health and Human Services (DHHS) regulations at 45 CFR 46.103(d) require that the adequacy of Institutional Review Boards (IRBs) be evaluated in light of the anticipated scope of the institution's research activities, the types of subject populations likely to be involved,... and the size and complexity of the institution. The regulations further require at 45 CFR 46.107(a) that IRBs be (i) sufficiently qualified through... the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel; and (ii) able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. IRBs must also be capable of ensuring that (i) selection of subjects is equitable; (ii) privacy of subjects is protected and confidentiality of data is maintained; (iii) informed consent is sought in language understandable to the subject and under conditions that minimize the possibility of coercion or undue influence; and (iv) appropriate safeguards protect the rights and welfare of vulnerable subjects [45 CFR 46.111(a)(3),(a)(4),(a)(7),(b), and 46.116].

7. 7 2. Local context issues If an outside IRB such as CDC’s approves a study, how do they assure local context sensitivity? ― Some type of consultation should be occurring Role of local researcher involvement with CDC and others to assure local sensitivity (not just national researchers descending on us) ― E.g., post-Katrina, our researchers, some of whom were never evacuated, were working on various research projects –– then many weeks later outsiders come in as if nothing local is going on to build on. ― Local researchers who know the population can enrich the research effort (Erin Brockovich effect)

8. 8 3. FWA Responsibilities of Local Institutions The institution is responsible, under its FWA, for developing, funding, and supporting a human subject protection program (much more than an IRB). Outside disaster researchers often involve a local researcher (who is in the know) or want to use local data (that belongs to a local institution and is PHI). Institution employees being involved in research, or the use of identified patient information from the institution, typically engages the institution in research. This requires two approvals: 1. IRB approval by an IRB on the institution’s FWA 2. Institutional approval by VP-Research or similar (issues of liability, contracts, costs, HIPAA, etc.)

9. 9 Summary All subjects, especially vulnerable disaster victims, should have the protections the IRB system is designed for. Sensitivity to local context and to local researchers being involved is important to successful research and to subject protection. Local institutions have responsibilities under their FWA and corporate charter that cannot be deferred to others without assurance that equal or better protection is there. There may be other ways of providing these protections than approval by a local IRB, but be careful not to short- circuit these protections