The approach to informed consent in acute care research
Rafael Dal-Ré, Arthur L Caplan
Lancet Respiratory Medicine, 3 November 2022
In their discussion of the contrasting responses of the UK and the USA to the unprecedented situation posed by the COVID-19 pandemic—and the urgent need for randomised controlled trials to guide clinical practice—Jonathan D Casey and colleagues state that the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial was approved “with an alteration of informed consent” to facilitate enrolment. We are concerned that this statement could confuse clinical investigators and research ethics committee members…
Editor’s note: The article referenced in this correspondence is Casey JD Beskow LM Brown J et al. Use of pragmatic and explanatory trial designs in acute care research: lessons from COVID-19. Lancet Respir Med. 2022; 10: 700-714.