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As industry-sponsored clinical trials become more complex and span larger patient populations in multiple sites across states, the demands on institutional review boards grow.
Despite the suggestions by Health and Human Services and the FDA to centralize IRB review of multi-site studies, many institutions still have not used a central IRB (CIRB).(1) While over half have used outside IRBs for support, only ten percent of the workload has been transferred to the central IRB. (2)
The reasons for this are varied, but one major concern continues to be liability, although federal agencies have also provided guidance on how to manage risk. Others are concerned that central IRBs’ decisions may be inconsistent with their own institutional policies and procedures. Finally, opponents to central IRBs suggest that only local reviewers can reflect the standards and values of their communities.
In one study (3) that looked at IRB reviews, however, the changes to the protocol are largely 8in alignment with standardized institutional language and offered no meaningful changes to the protocol that would impact local values. Meanwhile, according to the study, the costs of individual reviews by multiple local IRBs was upwards of $100,000.
A 2009 report by AAHRP demonstrated that nearly 90 percent of organizations reported increased workloads, with the average IRB reviewing 400 protocols. As both study sites and sponsors are seeking ways to improve efficiencies and reduce redundancies, the role of a central IRB requires another look. There are various ways to ensure a streamlined approach so that local and central IRBs can collaborate, each with a clear understanding of the others’ responsibilities.
Institutional research offices and local IRBs continue to have a critical role in maintaining and enforcing policies regarding human subject research, in educating investigators on protocol development, in reviewing investigator-initiated protocols, and in protecting accreditations.
Investigator-initiated trials have their own issues that require close IRB scrutiny. Without the oversight and structure of commercial sponsors, institutions must fill the gap to ensure regulatory compliance. By shifting IRB responsibility for industry-sponsored trials to a central IRB, more time and attention can be focused on these local trials.
A 2008 study (4) showed that CIRB use could result in shorter review periods and up to six hours of research staff effort. On average, over $700 were saved per initial review. With IRBs reviewing hundreds of protocols, these savings quickly add up. These potential cost savings could allow research offices to reallocate resources to other areas, and improve efficiencies throughout the process.
1 Loh ED, Meyer RE: Medical schools’ attitudes and perceptions regarding the use of central institutional review boards. Acad Med 2004, 79:644-651. 2 AAHRP 2009 Report 3 Ann Neurol. Author manuscript; available in PMC 2011 February 1.
4 Wagner TH: Costs and Benefits of the National Cancer Institute Central Institutional Review Board. American Society of Clinical Oncology. September 2008.