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

Authors :
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
Gordon R. Bernard
Source :
Journal of Clinical and Translational Science, Vol 6 (2022)
Publication Year :
2022
Publisher :
Cambridge University Press, 2022.

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.

Details

Language :
English
ISSN :
20598661
Volume :
6
Database :
Directory of Open Access Journals
Journal :
Journal of Clinical and Translational Science
Publication Type :
Academic Journal
Accession number :
edsdoj.5468b7195462473dac6a6dd39adf8777
Document Type :
article
Full Text :
https://doi.org/10.1017/cts.2022.391