Restarting Respiratory Clinical Research in the Era of the Coronavirus Disease 2019 Pandemic

Chest. 2021 Mar;159(3):1173-1181. doi: 10.1016/j.chest.2020.11.001. Epub 2020 Nov 13.


The clinical research we do to improve our understanding of disease and to develop new therapies has temporarily been delayed as the global health-care enterprise has focused its attention on those impacted by coronavirus disease 2019 (COVID-19). Although rates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are decreasing in many areas, many locations continue to have a high prevalence of infection. Nonetheless, research must continue and institutions are considering approaches to restarting non-COVID-related clinical investigation. Those restarting respiratory research must navigate the added planning challenges that take into account outcome measures that require aerosol-generating procedures. Such procedures potentially increase risk of transmission of SARS-CoV-2 to research staff, use limited personal protective equipment, and require conduct in negative-pressure rooms. One must also be prepared to address the potential for COVID-19 resurgence. With research subject and staff safety and maintenance of clinical trial data integrity as the guiding principles, here we review key considerations and suggest a step-wise approach for resuming respiratory clinical research.

Keywords: COVID-19; SARS-CoV-2; aerosol generating; clinical research; spirometry.

Publication types

  • Review

MeSH terms

  • Aerosols / adverse effects*
  • Biomedical Research* / methods
  • Biomedical Research* / organization & administration
  • Biomedical Research* / trends
  • COVID-19* / epidemiology
  • COVID-19* / prevention & control
  • COVID-19* / transmission
  • Communicable Disease Control / instrumentation
  • Communicable Disease Control / methods
  • Humans
  • Infectious Disease Transmission, Patient-to-Professional / prevention & control*
  • Risk Assessment
  • SARS-CoV-2


  • Aerosols