The approach to informed consent in acute care research – Authors' reply
Rafael Dal-Ré and Arthur L Caplan state that obtaining consent “was clearly not an issue in RECOVERY [the Randomised Evaluation of COVID-19 Therapy trial]” and use this statement to support their supposition that there is “no need” to reconsider regulations for written informed consent obtained prospectively from acutely ill patients. However, in the RECOVERY trial,1 if no family member was available, patients who lacked capacity to consent could be enrolled without providing informed consent through the involvement of a doctor (independent of the study team) who could act as the lega...
Source: thelancet.com