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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...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Cambridge University Press
2021
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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. |
format | Online Article Text |
id | pubmed-8220014 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Cambridge University Press |
record_format | MEDLINE/PubMed |
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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