irb perspective: concept of the community-wide irb david c. clark, phd assistant dean for clinical...

IRB Perspective:

Concept of theCommunity-Wide IRB

David C. Clark, PhD

Assistant Dean for Clinical Research

Medical College of Wisconsin

Outline

• Required elements• Staging approval -- a practical consideration• The role of community-wide IRBs

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)

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

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

Exclusions

Waiver explicitly excludes:• Pregnant women, fetuses, human in vitro fertilization

• Prisoners

• What if some pregnant women accidentally included?

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

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

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)

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

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

Disadvantages of community IRB review

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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?)

What is a successful community consultation?

• Community support ratio (51%)?• Sampling strategies (representativeness)?• Indication from community that there was

enough consultation?