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Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic

The COVID-19 pandemic changed the clinical research landscape in America. The most urgent challenge has been to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. International Review Board (IRB) offices developed plans to rapidly rev...

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Autores principales: Ford, Daniel E., Johnson, Ann, Nichols, Jason J., Rothwell, Erin, Dubinett, Steve, Naeim, Arash
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8220014/
https://www.ncbi.nlm.nih.gov/pubmed/34192061
http://dx.doi.org/10.1017/cts.2021.27
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author Ford, Daniel E.
Johnson, Ann
Nichols, Jason J.
Rothwell, Erin
Dubinett, Steve
Naeim, Arash
author_facet Ford, Daniel E.
Johnson, Ann
Nichols, Jason J.
Rothwell, Erin
Dubinett, Steve
Naeim, Arash
author_sort Ford, Daniel E.
collection PubMed
description The COVID-19 pandemic changed the clinical research landscape in America. The most urgent challenge has been to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. International Review Board (IRB) offices developed plans to rapidly review protocols related to the COVID-19 pandemic. An online survey was conducted with the IRB Directors at Clinical and Translational Science Awards (CTSA) institutions as well as two focus groups. Across the CTSA institutions, 66% reviewed COVID-19 protocols across all their IRB committees, 22% assigned protocols to just one committee, and 10% created a new committee for COVID-19 protocols. Fifty-two percent reported COVID-19 protocols were reviewed much faster, 41% somewhat faster, and 7% at the same speed as other protocols. Three percent reported that the COVID-19 protocols were reviewed with much better quality, 32% reported slightly better quality, and 65% reported the reviews were of the same quality as similar protocols before the COVID-19 pandemic. IRBs were able to respond to the emergent demand for reviewing COVID-19 protocols. Most of the increased review capacity was due to extra effort by IRB staff and members and not changes that will be easily implemented across all research going forward.
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spelling pubmed-82200142021-06-23 Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic Ford, Daniel E. Johnson, Ann Nichols, Jason J. Rothwell, Erin Dubinett, Steve Naeim, Arash J Clin Transl Sci Special Communications The COVID-19 pandemic changed the clinical research landscape in America. The most urgent challenge has been to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. International Review Board (IRB) offices developed plans to rapidly review protocols related to the COVID-19 pandemic. An online survey was conducted with the IRB Directors at Clinical and Translational Science Awards (CTSA) institutions as well as two focus groups. Across the CTSA institutions, 66% reviewed COVID-19 protocols across all their IRB committees, 22% assigned protocols to just one committee, and 10% created a new committee for COVID-19 protocols. Fifty-two percent reported COVID-19 protocols were reviewed much faster, 41% somewhat faster, and 7% at the same speed as other protocols. Three percent reported that the COVID-19 protocols were reviewed with much better quality, 32% reported slightly better quality, and 65% reported the reviews were of the same quality as similar protocols before the COVID-19 pandemic. IRBs were able to respond to the emergent demand for reviewing COVID-19 protocols. Most of the increased review capacity was due to extra effort by IRB staff and members and not changes that will be easily implemented across all research going forward. Cambridge University Press 2021-03-16 /pmc/articles/PMC8220014/ /pubmed/34192061 http://dx.doi.org/10.1017/cts.2021.27 Text en © The Association for Clinical and Translational Science 2021 https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
spellingShingle Special Communications
Ford, Daniel E.
Johnson, Ann
Nichols, Jason J.
Rothwell, Erin
Dubinett, Steve
Naeim, Arash
Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic
title Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic
title_full Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic
title_fullStr Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic
title_full_unstemmed Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic
title_short Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic
title_sort challenges and lessons learned for institutional review board procedures during the covid-19 pandemic
topic Special Communications
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8220014/
https://www.ncbi.nlm.nih.gov/pubmed/34192061
http://dx.doi.org/10.1017/cts.2021.27
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