A snapshot of U.S. IRB review of COVID-19 research in the early pandemic.

Holly A. Taylor,Holly Fernandez Lynch,Kimberley Serpico,John Baumann,Emily E. Anderson

doi:10.1017/cts.2021.848

Abstract

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. Structured data requests were sent to members of the Consortium to Advance Effective Research Ethics Oversight directing Human Research Protection Programs (HRPP). 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. 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.

Highlights

In its early days, the COVID-19 pandemic strained the research enterprise in numerous ways
Research groups and Institutional Review Boards (IRBs) faced challenges related to the responsible conduct of research in the face of a public health crisis[1, 2, 3] and had to quickly adapt to review and oversee COVID-related research, while facing novel policy issues and a workforce largely relegated to working from home
Inspired by an analysis of ethics committee reviews of applications for research studies at a single hospital in China during the start of the pandemic there, we sought to characterize the type and volume of COVID-19 specific protocols submitted to IRBs during the first few months of the pandemic in the U.S, measure IRB turn-around time on these COVID-19 specific protocols, and describe adjustments to standard IRB review processes in response to COVID-19.6 In addition, we reviewed a limited set of IRB materials to explore whether human research protection programs (HRPP) encountered any novel ethical and regulatory issues in their review of early COVID-19 specific research protocols

Summary

Introduction

In its early days, the COVID-19 pandemic strained the research enterprise in numerous ways. Many studies that were ongoing when the pandemic began had to pause or transition to remote operations and new protocols related to COVID-19 rapidly proliferated. There is limited evidence about how IRBs conduct their work during human and natural disasters,[4,5] a gap that has so far persisted with regard to COVID-19. Better understanding these circumstances and IRB responses can help inform future efforts. Inspired by an analysis of ethics committee reviews of applications for research studies at a single hospital in China during the start of the pandemic there, we sought to characterize the type and volume of COVID-19 specific protocols submitted to IRBs during the first few months of the pandemic in the U.S, measure IRB turn-around time on these COVID-19 specific protocols, and describe adjustments to standard IRB review processes in response to COVID-19.6 In addition, we reviewed a limited set of IRB materials to explore whether HRPPs encountered any novel ethical and regulatory issues in their review of early COVID-19 specific research protocols

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Discussion

Conclusion