Public Approval of Exception From Informed Consent in Emergency Clinical Trials

Key Points Question How does the public view emergency research conducted with an exception from informed consent (EFIC)? Findings In this systematic review of survey data from 27 emergency clinical trials with responses from 42 448 individuals submitted by EFIC trial organizers to the US Food and Drug Administration, public attitudes regarding EFIC varied: 58.4% approved of EFIC in principle, 68.6% approved of family-member enrollment, 73.0% approved of personal enrollment, and 86.5% approved of community inclusion. Groups surveyed with higher proportions of African American and male respondents had lower rates of EFIC approval, and these groups were underrepresented in surveys relative to their enrollment in EFIC trials. Meaning The US Food and Drug Administration should aim to build greater public consensus around the appropriate use of EFIC.