A national IRB model was developed to make the IRB review process more efficient and to offer research organizations an alternative to the central IRB model.
IRBrely was adapted by the National IRB Reliance Initiative (NIRI) from regional IRB reliance efforts led by a number of CTSA sites, including those based at Harvard University in Boston, Case Western Reserve University of Cleveland, the University of Wisconsin-Madison, and the University of California system, says Barbara Bierer, MD, professor of medicine, pediatrics, at Brigham and Women’s Hospital and Harvard Medical School in Boston. Bierer also is senior reliance advisor for NIRI.
The Ohio IRB Reliant model covers the state of Ohio with eight institutions. The Greater Plains IRB Consortium, which includes the University of Wisconsin-Madison, spans seven states and 10 institutions. The University of California model spans the 10 UC campuses and Lawrence Berkeley National Laboratory.
Key features of the national IRB reliance agreement include:
1. Investigators request single site review for a multisite study, utilizing the IRB reliance network. Informatics support with a Web-based system under development support reliance both to join the National IRB Reliance Initiative, as well as to rely on another institution for any given study protocol, Bierer says.
2. Sign on to the National IRB Reliance Agreement through a Joinder Agreement.
3. Delineated role responsibility for the following:
• Reviewing IRB: responsible for review and follow-up; ensures enrollment at each site commences only after all local institutional training and approvals have occurred; reports relevant unanticipated problems, adverse events, and deviations to participating institutions;
• relying on institution and relying on IRB remain responsible for study training, managing conflicts of interest, and ensuring compliance with the reviewing IRB mandates;
• chain of responsibility and communication through a lead study team via the overall PI responsible for research conducted at all sites; primary employer of the overall principal investigator is the presumed or default reviewing IRB, Bierer says.
4. IRB reliance is not mandated, but is determined on a study-by-study basis; if a study is deemed appropriate for IRB reliance, a study-specific authorization agreement need not be executed as the National IRB Reliance Agreement Network Joinder serves as the authorization agreement, Bierer adds.
Establishing an IRB reliance agreement may take time and effort, but it will make the IRB review process faster for multisite trials, Bierer notes.