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Restarting Human Participant Research at Community-based Observational Studies during the COVID-19 Pandemic
Raghava S Velagaleti1,2,3, Ramachandran S Vasan2
1Cardiology Section Department of Medicine Veterans Affairs Boston Healthcare System West Roxbury MA.
Insights
This review offers guidance for safely reopening community-based observational studies halted by the COVID-19 pandemic. It details pandemic assessment, safety protocols, and participant screening for resuming human participant research.
Area of Science:
- Public Health
- Epidemiology
- Research Methodology
Background:
- The COVID-19 pandemic led to widespread suspension of human participant research (HPR), including community-based observational cohort studies.
- Existing guidelines address clinical trials and health services but lack specific recommendations for observational research.
- Resuming observational studies is crucial due to their long-term value and the potential to contribute to pandemic understanding.
Purpose of the Study:
- To provide a framework for the safe resumption of community-based observational cohort studies.
- To synthesize best practices for pandemic status assessment, screening, and infection control.
- To offer actionable plans for restructuring research operations.
Main Methods:
- Narrative review synthesizing scientific literature and best practices.
- Analysis of governmental and medical society recommendations.
- Integration of infection prevention and environmental safety principles.
Main Results:
- A phased approach to reopening, guided by pandemic metrics and risk assessment.
- Recommendations for screening and surveillance of employees and participants for COVID-19.
- Operational plans for adapting study procedures and environments.
Conclusions:
- Safe reopening of observational cohort studies is feasible and necessary.
- A structured approach incorporating infection control is vital for protecting participants and staff.
- Observational studies can play a role in characterizing the pandemic's impact.
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.
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