101. Key lessons and strategies for implementing single IRB review in the Trial Innovation Network
- Author
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Ann R. Johnson, Megan Kasimatis Singleton, Julie Ozier, Emily Serdoz, Jennifer G. Beadles, Janelle Maddox-Regis, Sarah Mumford, Jeri Burr, J. Michael Dean, Daniel E. Ford, and Gordon R. Bernard
- Subjects
IRB ,Single IRB ,Human Research Protection ,Reliance agreement ,Local context ,Medicine - 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.
- Published
- 2022
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