Use of Deferred Consent in Randomized Clinical Trials

AbstractGood clinical practice standards mandate that informed consent be obtained before enrollment for all trials that present more than minimal risk to participants. Deferred consent, the process of enrolling patients in a clinical trial before consent is obtained, is sometimes employed in emergency care settings when patients are unable to consent at the time of trial enrollment, are critically ill, and a delay in enrollment would preclude them from potentially benefiting from the trial treatment. This article reviews the risks and benefits associated with the use of deferred consent in randomized controlled trials and the ethical acceptability of its use within specific clinical trial contexts.