Emergency Use of Unproven Interventions Outside of Research. Ethics Guidance for the COVID-19 Pandemic, 25 June 2020

Abstract

The COVID-19 pandemic presents us with the moral urgency to conduct rigorous research as soon as possible to produce evidence about the safety and efficacy of interventions to treat or prevent COVID-19. However, as in previous emergencies, marked by high mortality and the absence of safe and efficacious treatments, interventions that have not been previously proven for COVID-19 are being offered outside of protocols of research with human subjects. Since the safety and efficacy of these interventions have not been proven yet, their risk-benefit profile is unknown. Yet in the exceptional circumstances of the pandemic, they are being offered as an attempt to advance access to interventions that may benefit patients. As recommended by the Pan American Health Organization and the World Health Organization, unproven interventions should be offered within research protocols, and specifically within randomized controlled trials capable of assessing safety and efficacy.