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. 2022 Apr 19;6(1):e53.
doi: 10.1017/cts.2022.391. eCollection 2022.

Key lessons and strategies for implementing single IRB review in the Trial Innovation Network

Ann R Johnson  1 , Megan Kasimatis Singleton  2 , Julie Ozier  3 , Emily Serdoz  3 , Jennifer G Beadles  3 , Janelle Maddox-Regis  2 , Sarah Mumford  1 , Jeri Burr  4 , J Michael Dean  4 , Daniel E Ford  2 , Gordon R Bernard  3
Affiliations

Key lessons and strategies for implementing single IRB review in the Trial Innovation Network

Ann R Johnson et al. J Clin Transl Sci. .

Abstract

The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network's single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.

Keywords: Human Research Protection; IRB; Local context; Reliance agreement; Single IRB.

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Conflict of interest statement

The authors have no conflicts of interest to declare.

Figures

Fig. 1.
Fig. 1.
Human Research Elements of Protection & Oversight.
See this image and copyright information in PMC

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