1. IRB Perspective: Concept of the Community-Wide IRB David C. Clark, PhD Assistant Dean for Clinical Research Medical College of Wisconsin

2. Outline Required elements Staging approval -- a practical consideration The role of community-wide IRBs

3. Element 7: Additional protections Value-neutral questions that are sensitive to community norms and expectations Public disclosure after completion to apprise community of results, including demographics Creation of an independent data monitoring committee (not members of research team – variety of experts)

4. Element 8: Refreshing consent IRB responsible for ensuring that procedures are in place to inform each subject (or LAR), at earliest opportunity, of subject’s inclusion, details of investigation, and full consent information… … and procedures exist to inform subject that he/she may discontinue participation at any time If LAR used and subject improves, must consent subject If subject dies before LAR consent obtained, investigator must inform LAR about study participation as soon as possible

5. Additional FDA requirements IRB must document that licensed physician -- member of or consulting to IRB (and not participating in clinical investigation) -- agrees that waiver is allowable, by recording this in minutes

6. Exclusions Waiver explicitly excludes: Pregnant women, fetuses, human in vitro fertilization Prisoners What if some pregnant women accidentally included?

7. Staging the IRB review The concept of explicit “stages” “Feasibility and planning” stage “Community disclosure and consultation” stage “Final implementation readiness” stage Approval granted for well-delineated stages, rather than for entire study plan Investigators and IRB work together to formulate mutually acceptable “staging” units and boundaries

8. Inter-Institutional Agreements Any FWA institution may defer IRB review to another FWA institution by means of a written Inter-Institutional Agreement IRB of records takes responsibility for IRB requirements based on information submitted (know your partner!) Deferring institutions still have responsibility for their investigators, their involvement, and implementation of study

9. Community-wide IRBs Several IRBs may develop a common Inter- Institutional Agreement, with supporting MOU and conventions memorialized as “policies,” to create a “community-wide IRB” Wisconsin IRB Consortium  University of Wisconsin at Madison  Medical College of Wisconsin (Milwaukee)  Marshfield Clinic (40 centers in N, W and central WI)  Gundersen Lutheran Health System (La Crosse)  Aurora Health Care (Milwaukee)

10. Role of community-wide IRBs Common Inter-Institution Agreements, policies and procedures for “network” studies facilitate multi-site reviews Consensual decision about “lead institution” Subsidiary sites may defer review; conduct a facilitated review; or conduct a full committee review Network orchestrates sequence and timing of reviews

11. Advantages of community-wide IRBs Each participating institution chooses its own preferred level of review, study by study Potential: for single IRB review with built-in procedures for considering “local context” for full-information continuing reviews to choreograph consent form language across multiple institutional IRBs

12. Disadvantages of community IRB review

13. What is a successful community consultation? Type of consultation (community meeting, focus group, survey)? Number of consultations? Number of persons consulted? (Limited time, staffing, and budget -- how much “respect for persons” can we afford?)

14. What is a successful community consultation? Community support ratio (51%)? Sampling strategies (representativeness)? Indication from community that there was enough consultation?