Restarting Human Participant Research at Community‐based Observational Studies during the COVID‐19 Pandemic

Abstract

At the onset of the Coronavirus Disease 2019 (COVID‐19) pandemic, just as public institutions and businesses closed, research programs performing human participant research (HPR) also largely ceased operations. With the partial ebbing of the pandemic in some areas, universities and healthcare organizations conducting HPR are considering reopening. Whereas guidelines from governmental authorities and medical specialty societies currently exist to help restarting health services and resuming clinical trials, no clear guidance is available to aid resumption of HPR at community‐based observational cohort studies. Indefinite stoppage of observational research at cohort studies carries many drawbacks and its safe resumption is important and feasible. In this narrative review, we describe a potential path forward for safely reopening community‐based observational studies, drawing on scientific knowledge and best practices from a variety of medical and lay sources. We highlight current recommendations regarding pandemic status assessment and the metrics useful for guiding decisions regarding safe reopening/reclosing and for screening and surveillance of COVID‐19 among employees and participants. We synthesize insights from contemporary literature regarding infection prevention and environmental safety into a set of easy to operationalize plans for restructuring HPR. And lastly, we suggest ways in which observational studies can potentially aid the efforts to characterize the pandemic.

Keywords

• community‐based cohort studies
• observational research
• COVID‐19 pandemic
• infection control
• environmental safety
• reopening