In April of 2020, I posted on Ampersand announcing a survey. We aimed to understand the ethical, regulatory, and practical barriers to conducting and overseeing COVID-19 research. We recruited COVID-19 researchers and IRB chairs, directors, or delegates who reviewed COVID-19 research. We are deeply grateful for the support PRIM&R provided for our recruitment efforts.

We are pleased to report that we received 211 responses from researchers, and 143 responses from IRB chairs, directors, or delegates. Our data was collected between April 21, 2020, and July 30, 2020, thus reflecting very early experience during the pandemic.

Our surveys primarily used open-ended questions because too little was known, and the need for a survey was too urgent, to develop high-quality close-ended items. We asked IRB participants to reflect on their experience thus far in the pandemic and to describe:

• Logistical challenges
• Ethical, regulatory, or policy challenges
• Accommodations or changes made
• Advice for peers and COVID-19 researchers

We received a wealth of information from our participants. Our study’s primary findings are reported in an article in PLOS ONE, “Ethical, regulatory, and practical barriers to COVID-19 research: A stakeholder-informed inventory of concerns.”

Table 4 presents a list of 19 barriers to overseeing COVID-19 research with illustrative quotes. Table 5 provides a list of proposed adaptations and solutions offered by both researchers and IRB participants with numerous quotes that illustrate the solutions. These solutions fell into several broad categories including:

• enacting technological solutions;
• developing protocol-based solutions;
• disposition and team management;
• establishing and communicating appropriate standards;
• national guidance and leadership;
• maintaining high standards;
• prioritizing studies before IRB review; and
• identifying and incorporating experts.

Additionally, we published a double-issue of Narrative Inquiry in Bioethics that included 16 stories from IRB leaders and 17 stories from COVID-19 researchers. These stories are valuable insofar as they present far more detail and context than our open-ended survey responses. The stories are followed by 6 commentary articles, including one from Jerry Menikoff, MD, JD, the Director of OHRP. The issue is currently open access.

Additionally, we developed a discussion guide with 3 reflection questions for each story. Facilitators may use the guide to lead discussions with IRB members that explore ethical, regulatory, and logistical barriers to doing research on a pandemic during a pandemic.

In general, researchers offered praise for IRBs, noting how hard they worked to facilitate COVID-19 research in a responsible manner. Further, IRBs have found solutions to many of the challenges posed by COVID-19, especially in the earliest days of the pandemic. Nevertheless, we believe that our findings should stimulate reflection and action. In a separate paper (currently under review), we note several significant barriers that remain, including conflicting interests, the need to triage protocols, and the difficulties of multisite research and data sharing. COVID-19 was bad, but death rates were relatively low when compared to diseases such as Ebola. We believe the US research enterprise did well during the pandemic, but it could—and may need to—do much better.

James M. DuBois, DSc, PhD is the Principal Investigator and Director for the Bioethics Research Center at Washington University School of Medicine.