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...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2021-01-01
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| Series: | Journal of Clinical and Translational Science |
| Subjects: | |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866121000273/type/journal_article |
| _version_ | 1811156611895394304 |
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| author | Daniel E. Ford Ann Johnson Jason J. Nichols Erin Rothwell Steve Dubinett Arash Naeim |
| author_facet | Daniel E. Ford Ann Johnson Jason J. Nichols Erin Rothwell Steve Dubinett Arash Naeim |
| author_sort | Daniel E. Ford |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-04-10T04:53:09Z |
| format | Article |
| id | doaj.art-e9979aef402e4ce68b313d0544ec484e |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-10T04:53:09Z |
| publishDate | 2021-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-e9979aef402e4ce68b313d0544ec484e2023-03-09T12:31:03ZengCambridge University PressJournal of Clinical and Translational Science2059-86612021-01-01510.1017/cts.2021.27Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemicDaniel E. Ford0https://orcid.org/0000-0002-2549-2289Ann Johnson1Jason J. Nichols2https://orcid.org/0000-0003-1519-7734Erin Rothwell3https://orcid.org/0000-0002-2294-2299Steve Dubinett4Arash Naeim5School of Medicine, Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, USASchool of Medicine, IRB Office, University of Utah, Salt Lake City, UT, USASchool of Optometry, Department of Vision Sciences, School of Medicine, Center for Clinical and Translational Sciences, The University of Alabama at Birmingham, Birmingham, AL, USASchool of Medicine, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT, USADepartment of Medicine, David Geffen School of Medicine at UCLA, Clinical and Translational Sciences Institute, Los Angeles, CA, USADepartment of Medicine, David Geffen School of Medicine at UCLA, Clinical and Translational Sciences Institute, Los Angeles, CA, USAThe 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.https://www.cambridge.org/core/product/identifier/S2059866121000273/type/journal_articleInternal review boardCOVID-19informed consentprotocol reviewprotection of human subjects |
| spellingShingle | Daniel E. Ford Ann Johnson Jason J. Nichols Erin Rothwell Steve Dubinett Arash Naeim Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic Journal of Clinical and Translational Science Internal review board COVID-19 informed consent protocol review protection of human subjects |
| 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 | Internal review board COVID-19 informed consent protocol review protection of human subjects |
| url | https://www.cambridge.org/core/product/identifier/S2059866121000273/type/journal_article |
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