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

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 be...

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Autores principales: Johnson, Ann R., Kasimatis Singleton, Megan, Ozier, Julie, Serdoz, Emily, Beadles, Jennifer G., Maddox-Regis, Janelle, Mumford, Sarah, Burr, Jeri, Dean, J. Michael, Ford, Daniel E., Bernard, Gordon R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9120617/
https://www.ncbi.nlm.nih.gov/pubmed/35656335
http://dx.doi.org/10.1017/cts.2022.391
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author Johnson, Ann R.
Kasimatis Singleton, Megan
Ozier, Julie
Serdoz, Emily
Beadles, Jennifer G.
Maddox-Regis, Janelle
Mumford, Sarah
Burr, Jeri
Dean, J. Michael
Ford, Daniel E.
Bernard, Gordon R.
author_facet Johnson, Ann R.
Kasimatis Singleton, Megan
Ozier, Julie
Serdoz, Emily
Beadles, Jennifer G.
Maddox-Regis, Janelle
Mumford, Sarah
Burr, Jeri
Dean, J. Michael
Ford, Daniel E.
Bernard, Gordon R.
author_sort Johnson, Ann R.
collection PubMed
description 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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spelling pubmed-91206172022-06-01 Key lessons and strategies for implementing single IRB review in the Trial Innovation Network Johnson, Ann R. Kasimatis Singleton, Megan Ozier, Julie Serdoz, Emily Beadles, Jennifer G. Maddox-Regis, Janelle Mumford, Sarah Burr, Jeri Dean, J. Michael Ford, Daniel E. Bernard, Gordon R. J Clin Transl Sci Special Communications 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. Cambridge University Press 2022-04-19 /pmc/articles/PMC9120617/ /pubmed/35656335 http://dx.doi.org/10.1017/cts.2022.391 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Special Communications
Johnson, Ann R.
Kasimatis Singleton, Megan
Ozier, Julie
Serdoz, Emily
Beadles, Jennifer G.
Maddox-Regis, Janelle
Mumford, Sarah
Burr, Jeri
Dean, J. Michael
Ford, Daniel E.
Bernard, Gordon R.
Key lessons and strategies for implementing single IRB review in the Trial Innovation Network
title Key lessons and strategies for implementing single IRB review in the Trial Innovation Network
title_full Key lessons and strategies for implementing single IRB review in the Trial Innovation Network
title_fullStr Key lessons and strategies for implementing single IRB review in the Trial Innovation Network
title_full_unstemmed Key lessons and strategies for implementing single IRB review in the Trial Innovation Network
title_short Key lessons and strategies for implementing single IRB review in the Trial Innovation Network
title_sort key lessons and strategies for implementing single irb review in the trial innovation network
topic Special Communications
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9120617/
https://www.ncbi.nlm.nih.gov/pubmed/35656335
http://dx.doi.org/10.1017/cts.2022.391
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