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

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

doi:10.1017/cts.2022.391

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

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

School of Medicine

Research output: Contribution to journal › Article › peer-review

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.

Original language	English (US)
Article number	e53
Journal	Journal of Clinical and Translational Science
Volume	6
Issue number	1
DOIs	https://doi.org/10.1017/cts.2022.391
State	Published - Apr 19 2022

Keywords

Human Research Protection
IRB
Local context
Reliance agreement
Single IRB

ASJC Scopus subject areas

General Medicine

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10.1017/cts.2022.391

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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.",

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note = "Funding Information: The work reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health (NIH) under award numbers U24TR001608, U24TR001597, U24TR001609, and U24TR001579. The content is solely the responsibility of the authors and does not necessarily represent the official view of the NIH. Publisher Copyright: {\textcopyright} 2022 The Author(s).",

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doi = "10.1017/cts.2022.391",

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AU - Maddox-Regis, Janelle

AU - Mumford, Sarah

AU - Burr, Jeri

AU - Dean, J. Michael

AU - Ford, Daniel E.

AU - Bernard, Gordon R.

N1 - Funding Information: The work reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health (NIH) under award numbers U24TR001608, U24TR001597, U24TR001609, and U24TR001579. The content is solely the responsibility of the authors and does not necessarily represent the official view of the NIH. Publisher Copyright: © 2022 The Author(s).

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

Abstract

Keywords

ASJC Scopus subject areas

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