Emergency Care Research and Exception from Informed Consent: Addressing the Spectrum of Capacity for Consent

Emergency care research conducted under exception from informed consent (EFIC) involves confronting well-known ethical and practical challenges. There has been significant experience addressing those challenges, but most of this experience has been with clinical trials for conditions such as cardiac arrest, in which no patients can provide consent. Important questions remain regarding how to approach EFIC studies in contexts where patients (and surrogates) fall along a spectrum of potential involvement in enrollment decisions. In this piece, which derives from a National Institutes of Health workshop on EFIC, we address two sets of challenges. First, what thresholds should investigators and institutional review boards use in determining whether it is impracticable to obtain informed consent from patients with an emergency condition, and when is EFIC necessary when a spectrum of capacity exists? We highlight the importance of patient-level and population-level considerations in determining practicability and argue against any fixed criterion regarding the number of patients who require EFIC enrollment in order for EFIC to be justified. Second, how and when should research teams engage patients and surrogates prospectively to provide an opportunity for them to decline to participate in emergency care research when some engagement is possible but informed consent is not? We review evidence in favor of providing an opportunity to decline inclusion when possible and highlight the need to share strategies and empirically evaluate how best to operationalize this aspect of EFIC studies.