ABSTRACT
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.