Ethical, regulatory, and practical barriers to COVID-19 research: A stakeholder-informed inventory of concerns

Abstract

Introduction SARS-CoV-2 (COVID-19) has caused death and economic injury around the globe. The urgent need for COVID-19 research created new ethical, regulatory, and practical challenges. The next public health emergency could be worse than COVID-19. We must learn about these challenges from the experiences of researchers and Research Ethics Committee professionals responsible for these COVID-19 studies to prepare for the next emergency. Materials and methods We conducted an online survey to identify the ethical, oversight, and regulatory challenges of conducting COVID-19 research during the early pandemic, and proposed solutions for overcoming these barriers. Using criterion-based, convenience sampling, we invited researchers who proposed or conducted COVID-19 research to complete an anonymous, online survey about their experiences. We administered a separate but related survey to Institutional Review Board (IRB) professionals who reviewed COVID-19 research studies. The surveys included open-ended and demographic items. We performed inductive content analysis on responses to open-ended survey questions. Results IRB professionals (n = 143) and researchers (n = 211) described 19 types of barriers to COVID-19 research, related to 5 overarching categories: policy and regulatory, biases and misperceptions, institutional and inter-institutional conflicts, risks of harm, and pressure of the pandemic. Researchers and IRB professionals described 8 categories of adaptations and solutions to these challenges: 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. Discussion and conclusions This inventory of challenges represents ongoing barriers to studying the current pandemic, and they represent a risk to research during future public health emergencies. Delays in studies of a pandemic during a pandemic threatens the health and safety of the public. We urge the development of a national working group to address these issues before the next public health emergency arises.

Research ethics review during the COVID-19 pandemic: An international study

“…Kyrgyzstan [27], Latin America [28], the Netherlands [29], Pakistan [30], South Africa [31,32], Turkey [33], and the United States [34][35][36] Conversely, several ERCs availed themselves of international guidelines (Box 2), in particular those prepared by WHO [37][38][39][40] and PAHO [41][42][43][44].…”

Navigating Conflicting Interests in Pandemic Research: Preparing the US Research Infrastructure for a Worse Pandemic

“…Our group surveyed 211 COVID-19 researchers and 143 institutional review board (IRB) leaders during the early months of the pandemic in the United States (US) to identify ethical, regulatory, and logistical barriers to performing research on COVID-19, with full results published elsewhere. 3 From this study and review of the literature, we found that COVID-19 research collaboration and productivity was stymied by conflicting interests related to accessing patients, data, and investigational drugs for research. In a future pandemic, these unresolved conflicts could impede essential research and lead to even greater societal harms.…”

“…While multicentered trials were the ideal, many researchers were denied access to existing multicenter trials, despite best efforts, for seemingly arbitrary reasons. 4 Researchers also struggled to engage non-academic research organizations in recruitment efforts, with some Health Departments perceiving recruitment efforts of clinical trialists to be “unethical.” 3 Researchers decried the lack of national leadership for conducting multicenter trials and addressing conflicts over access to patients, which led to competition rather than cooperation.…”