ABSTRACT
The coronavirus disease 2019 (COVID-19) pandemic was a unique time in history to study the protection of human research subjects at medical schools. The COVID-19 pandemic resulted in an unprecedented disruption on the conduct of human subjects research in the United States. Medical schools around the country had to rapidly pivot and adopt new risk mitigation practices to protect research participants. The purpose of this study was to investigate the influence of the COVID-19 pandemic on the protection of human research subjects at medical schools. Five research medical institutions that are geographically spread across the United States were selected for this two-phase study. All five were among the top 25 NIH research funded institutions in 2021. Phase one included a deductive content analysis of publicly available research guidance documents using the Hierarchy of Controls as the conceptual framework. Based on the findings, a semi-structured interview protocol was developed and a research manager from each study site was interviewed. Guidelines and practices for the protection of human research subjects have changed as a result of the COVID-19 pandemic;however, IRB policies have not. Despite universal protective measures that should be taken, for example masking, there are nuances to research study modifications that were left at the study team level for the sites involved in this study. A practical implication from this study was that COVID-19 risk reduction plans are not a one size fits all approach. The medical schools in this study provided study teams with the flexibility to tailor risk mitigation procedures to the study population. A significant implication was the discovery that IRBs were not approving ramp up plans and it was typically done at the department level. The pandemic exposed weaknesses in medical schools' preparedness for the continuation of human subjects research during a public health emergency. It is recommended that their Institutional Review Boards (IRBs) develop an emergency plan to ensure the continuation of research during future pandemic or other public health emergencies. (PsycInfo Database Record (c) 2023 APA, all rights reserved)