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.

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