Special Communication: Challenges and Lessons Learned for Institutional Review Board Procedures during the COVID-19 Pandemic

Introduction: 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. Methods: IRB Offices developed plans to rapidly review protocols related to the COVID-19 pandemic. An online survey was performed of the IRB Directors at CTSA institutions as well as two focus groups. Results: Across the NCATS 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 of similar protocols before the COVID-19 pandemic. Conclusion: 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 in that will be easily implemented across all research going forward.

Authors
Daniel E Ford, Ann Johnson, Jason J Nichols, Erin Rothwell, Steve Dubinett and Arash Naeim
Journal
Journal of Clinical and Translational Science
Publication Date
Linked Authors
Ann
Johnson
Director, Institutional Review Board & Human Research Protection Program
Erin
Rothwell
Associate Vice President for Research Integrity
STEVEN
DUBINETT
UCLA Associate Vice Chancellor for Research