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. 2019 May;41(3):23-28.
doi: 10.1002/eahr.500016.

Implementing a Central IRB Model in a Multicenter Research Network

Jeri S Burr  1 , Ann R Johnson  2 , Valeriya Vasenina  3 , Stephanie Bisping  4 , R Whitney Coleman  5 , Jeffrey R Botkin  6 , J Michael Dean  7
Affiliations

Implementing a Central IRB Model in a Multicenter Research Network

Jeri S Burr et al. Ethics Hum Res. 2019 May.

Abstract

Implementing the National Institutes of Health's (NIH's) new single institutional review board (IRB) policy has caused a paradigm shift in IRB review across the country. IRBs and human research protection programs are looking more closely at their processes for ceding review and developing procedures to handle local review when relying on a single IRB. This article describes an NIH-funded network that proactively instituted a central IRB (CIRB) in 2012, anticipating the NIH future mandate. Lessons learned are described. There was a steep learning curve for IRBs and participating sites. IRB submission workload burden shifted from study teams to the data coordinating center, which created new workflow challenges, especially preparing hundreds of consent documents centrally. Despite difficulties encountered with CIRB review, this network is now fully functioning under a CIRB model. Further review and experience are needed to determine whether this shift in IRB review has eliminated duplicative review or regulatory burden from study teams.

Keywords: NIH; central IRB; human research protection program; institutional review board; local review; research network; single IRB.

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References

    1. Bellomo R, Warrillow SJ, and Reade MC, “Why We Should Be Wary of Single-Center Trials,” Critical Care Medicine 37, no. 12 (2009): 3114–19. - PubMed
    1. National Institutes of Health Office of Science Policy, “7.0 What Is the Difference between Central IRB and a Single IRB?,” https://osp.od.nih.gov/ufaqs/what-is-the-difference-between-a-central-ir....
    1. National Institutes of Health, Final NIH Policy on the Use of a Single Institutional Review Board for Multi-site Research National Institutes of Health (Washington, DC: Department of Health & Human Sciences, National Institutes of Health, June 2016).

    1. 45 C.F.R. 46.114.

    1. Check DK, et al., “Use of Central Institutional Review Boards for Multicenter Clinical Trials in the United States: A Review of the Literature,” Clinical Trials 10, no. 4 (2013): 560–67. - PubMed

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