Monday, September 26, 2011

Relying on Another Organization’s Institutional Review Board

Tip Sheet 24: Relying on An External IRB
Relying on another institution’s IRB, whether for a single research protocol or a portion of the organization’s research portfolio, is becoming more and more common. In this era of decreased resources when research must be timely, minimizing the number of IRBs reviewing the research is desirable, efficient, and cost-effective. In addition, accumulating evidence in the literature shows that multiple IRB reviews of the same protocol do not enhance participant protections and may actually diminish protections and the integrity of the research by causing variations in response rate, recruitment, and protocol procedures.1,2,3,4

Reliance on another IRB has raised three major issues of concern. The first is the question of the roles and responsibilities of the reviewing IRB and the relying organization. For example, which party is responsible for the education of investigators, and who handles non-compliance? Second, what mechanism does the relying organization to ensure the reviewing IRB will conduct reviews appropriately and in compliance with the regulations? The third issue is related to the second: What procedures does the reviewing IRB use to take into account the local context at the site where the research will be conducted?

It is important to develop a formal written agreement that clearly sets out the roles and responsibilities of each party. In addition, there should be a working and communicative relationship between the two organizations. The reviewing IRB would maintain responsibility for initial and continuing review and the review of amendments, along with the responsibilities related to those roles, such as making regulatory determinations and documenting those determinations. The relying organization would be responsible for reporting unanticipated problems, non-compliance, suspensions and terminations, and any other events requested by the IRB to the IRB. Other tasks that may be conducted by either party should be spelled out in the agreement, such as reporting IRB determinations to organizational officials and reporting unanticipated problems involving risks to participants or others, serious or continuing non-compliance, and suspensions or terminations of IRB approval to regulatory agencies and sponsors; post-approval monitoring, and education of investigators and research staff. The clear, formal, and written delineation of these roles, as well as good communication between the two parties, allows for a productive, efficient, and protective relationship.

But even if the responsibilities are clearly known, how can each party be assured that the other party will carried out it responsibilities appropriately? This is where accreditation is vitally important to IRB collaboration. At the 2006 National Conference on Alternative IRB Models, accreditation was noted numerous times as the basis for being able to rely on another IRB with confidence: “Accreditation can provide a baseline assurance of quality.”5 When you rely on an accredited organization, you can be assured that the organization and IRB have met the highest levels of regulatory compliance and performance in the world.

One barrier to relying on other IRBs came from OHRP’s policy favoring local review, in the belief that local review best accounted for local context. In a letter dated April 30, 2010, the director stated that OHRP has “archived prior guidance documents that suggested OHRP favors local IRB review over review by a non-local IRB, a position that OHRP no longer holds. (The reviewing IRB should nonetheless have appropriate knowledge of the local context.)”6 Accredited IRBs, through membership, consultants, or required mechanisms, should be knowledgeable of, or include in their review deliberations, issues related to local context. However, it should also be the responsibility of the relying organization to inform the IRB of any local context issues it deems important for consideration.

More and more universities and hospitals are using independent IRBs to review the industry-sponsored clinical trials in which they participate. Again, in this situation, formal written agreements are recommended to clearly lay out the roles of each organization. For example, if an independent IRB is charged with reviewing an international multi-site clinical trial that calls for adherence to ICH-GCP (E6), and the relying organization does not normally follow this guidance, the agreement should stipulate who is responsible for educating researchers and research staff on ICH-GCP (E6) requirements, as well as monitoring compliance with this guidance. It is also important when relying on an independent IRB to make sure that that the IRB is accredited. Many industry sponsors, particularly in the United States, are exclusively using accredited independent IRBs.

In summary, relying on another organization’s IRB or an independent IRB is becoming more common, driven in part by efficiency and cost issues. Relying on an accredited IRB provides assurance that the IRB meets high standards for quality, compliance, efficiency, and optimal protection of human participants. (See the new AAHRPP Tip Sheet on Relying on an External IRB.)
  1. Stair TO, Reed CR, Radeos MS, Koski G, Camargo CA. Variation in institutional review board responses to a standard protocol for a multicenter clinical trial. Acad Emerg Med. 2001;8(6):636-641.
  2. McWilliams R, Hoover-Fong J, Hamosh A, Beaty T, Cutting G. Problematic variation in local institutional review of a multicenter genetic epidemiology study. JAMA. 2003;290(3):360-366.
  3. Morahan PS, Yamagata H, McDade SA, Richman R, Francis R, Odhner VC. New challenges facing interinstitutional social science and education program evaluation research at academic health centers: a case study from the ELAM program. Acad Med. 2006;81(6):527-34.
  4. Green LE, Lowery JC, Kowalski CP Wyszewianski L. Impact of institutional review board practice variation on observational health services research. Health Services Research. 2006;41(1):214-230.
  5. 2006 Conference Summary Report - National Conference on Alternative IRB Models: Optimizing Human Subject Protection. Accessed September 14, 2011.
  6. OHRP Correspondence -April 30, 2010. Accessed September 14, 2011.

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