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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...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Cambridge University Press
2022
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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. |
format | Online Article Text |
id | pubmed-9120617 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Cambridge University Press |
record_format | MEDLINE/PubMed |
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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