A risk–benefit framework for human research during the COVID-19 pandemic

Abstract

The coronavirus disease 2019 (COVID-19) has had a profound impact on the academic research enterprise. Over the span of just a few weeks in March 2020, most large U.S. research institutions closed the majority of their laboratories, studios, and offices, suspended travel and fieldwork, and paused the majority of human research, resulting in the halt of more than 80% of all on-site research activity (1). After months of limited operations, laboratory-and field-based research in the basic and natural sciences were among the first activities to resume. These activities presented relatively low risk for transmission with implementation of proper control measures such as face coverings, health screens, and social distancing. Performing human research during a global pandemic, however, raises new ethical and practical challenges on a scale never before seen. Across the clinical, social, and behavioral sciences, human research can require close contact between researchers and participants, over variable observational periods, and across a variety of locations (e.g., clinics, schools, prisons). Therefore, research with human participants has been slower to resume given the risks associated with potential direct and/or airborne transmission between and among researchers and participants. Indeed, early evidence suggests that research disciplines that rely on face-to-face human contact are among the disciplines that have seen the steepest drop in productivity during the pandemic (2), despite the fact that human research constitutes a significant fraction of the research enterprise. Not all human research paused as stay-at-home orders were implemented across the United States. Work continued on projects that could be performed remotely, as did critical clinical work to help understand and develop solutions for the ongoing pandemic. Some COVID-19 therapeutic trials with potential immediate, life-saving benefit began with numerous safety precautions (3, 4). Many clinical trials with potential immediate life-saving benefit for a range of conditions continued through the pandemic, Performing human research during a global pandemic raises new ethical and practical challenges on a scale never before seen. To safely and ethically restart more of the human research portfolio, institutions must develop guiding principles and an explicit plan for managing human research during the pandemic.

Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic

“…The COVID-19 pandemic changed the clinical research landscape in America [1]. IRB leaders at academic health centers knew their offices would have to respond to several challenges associated with this pandemic [2]. The most urgent challenge was to rapidly review protocols submitted by investigators that were designed to learn more about COVID-19.…”

Conducting clinical research in the era of the COVID-19 pandemic: Challenges and lessons for Speech-Language Pathology and Audiology research

“…As far as research is concerned, significant challenges have been encountered in terms of the planning of clinical research designs, sourcing of funding for research as research priorities change, as well as significant questions around ethical clearance of studies conducted during the COVID-19 pandemic. Questions around ethical clearance have had ethical committees and institutional research review boards challenged by their mandate to facilitate ethical research whilst adhering to health and safety regulations implemented to protect and safeguard the safety of research participants and researchers (Beach et al, 2020 ; Lumeng et al, 2020 ; Perez et al, 2020 ; Sebothoma et al, 2021 ; Wieten, Burgart, & Cho, 2020 ). Weiner, Balasubramaniam, Shah and Javier ( 2020 ) believed that the impact that the COVID-19 pandemic had on general research and on research specific to the pandemic raises numerous important factors: (1) the significance of research, (2) challenges of research, especially during public health emergencies (PHEs) and (3) resources and opportunities towards improving research to become more efficient and cost effective.…”

“…The travel restrictions also impacted the access to research tools that are most often imported, particularly in LMICs. Lumeng et al ( 2020 ) further reported on how COVID-19 has had a significant effect on the academic research enterprise in the United States, with numerous research institutions shutting down their research laboratories, adjourning fieldwork and stopping a number of human research initiatives. This led to the cessation of over 80% of all on-site research activity – with research in the basic and natural sciences gradually resuming activities over the course of a few months (Lumeng et al, 2020 ).…”

Multi-level barriers faced and lessons learned to conduct a randomized controlled trial in patients with diabetes and prediabetes during the COVID-19 pandemic in Brazil

“…In addition, it is not possible to assure these first results reveal the real effects of interventions since current limitations and stress imposed on the participants can influence their outcomes. We have learned that the current global situation asks for additional phases in the Diabetes College Brazil Study to validate the results, including a feasibility RCT study with a virtual intervention 21 .…”