A snapshot of U.S. IRB review of COVID-19 research in the early pandemic. Issue 1 (13th September 2021)

• Record Type: Journal Article
• Authors: Taylor, Holly A.; Serpico, Kimberley; Lynch, Holly Fernandez; Baumann, John; Anderson, Emily E.
• Is Part Of: Journal of clinical and translational science. Volume 5:Issue 1(2021)
• Publication Date: 2021-09-13
• Subjects: COVID -- IRB -- turnaround time -- review process -- content analysis; Clinical medicine -- Research -- Periodicals; Medicine, Experimental -- Periodicals; Human experimentation in medicine -- Periodicals; 616.027
• DOI: 10.1017/cts.2021.848
• Languages: English
• ISSNs: 2059-8661

Abstract

Abstract: Background/Objective: Along with the greater research enterprise, Institutional Review Boards (IRBs) had to quickly adapt to the COVID-19 pandemic. IRBs had to review and oversee COVID-related research, while navigating strict public health measures and a workforce largely relegated to working from home. Our objectives were to measure adjustments to standard IRB review processes, IRB turnaround time and document and any novel ethical issues encountered. Methods: Structured data requests were sent to members of the Consortium to Advance Effective Research Ethics Oversight directing Human Research Protection Programs (HRPP). Results: Fourteen of the 32 HRPP director members responded to a questionnaire about their approach to review and oversight during COVID-19. Eleven of the 14 provided summary data on COVID-19-specific protocols and six of the 11 provided protocol-related documents for our review. All respondents adopted at least one additional COVID-19-specific step to their usual review process. The average turnaround time for convened and expedited IRB reviews was 15 calendar days. In our review of the documents from 194 COVID-19-specific protocols ( n = 302 documents), we identified only a single review that raised ethical concerns unique to COVID-19. Conclusions: Our data provide a snapshot of how HRPPs approached the review of COVID-19-specific protocols at the start of the pandemic in the USA. While not generalizable to all HRPPs, these data indicate that HRPPs can adapt and respond quickly response to a pandemic and likely need little novel expertise in the review and oversight of COVID-19-specific protocols.