Public Acceptance of Emergency Research Without Prior Consent in Stroke.

Abstract

When prospective informed consent is not feasible in time-sensitive emergencies, such as hyperacute ischemic stroke, international ethics guidance recognizes that enrollment without prior consent may be permissible. Little is known about public acceptance of emergency research without prospective consent (ERWPC) in countries lacking established pathways. To estimate public acceptance of ERWPC for hyperacute ischemic stroke, to identify factors associated with ERWPC acceptance, and to compare these factors with those associated with willingness to participate in a standard stroke randomized clinical trial (RCT) requiring prospective informed consent. This survey study was conducted in 2024 using hypothetical hyperacute stroke RCT scenarios. A commercial opt-in panel recruited adults aged 20 to 79 years residing in Japan, with equal allocation across age-by-sex strata. Participants completed survey components, including 8 conjoint scenarios with varying effectiveness, adverse event risk, and consent modality, and rated their willingness to join a standard RCT. The primary outcome was ERWPC acceptance, defined as selecting willing or rather willing to participate in at least 1 scenario in a hypothetical trial without prospective consent. The secondary outcome was willingness to participate in a standard RCT. Additional measures included conjoint utilities, value domain scores, decision style, and factors associated with both primary and secondary outcomes using multivariable logistic regression. Among 1000 respondents (mean [SD] age, 50.1 [15.6] years; 500 females [50.0%]), 605 (60.5%) accepted ERWPC in at least 1 scenario, whereas 334 (33.4%) were willing to join a standard RCT. Among those unwilling to join the standard RCT (n = 666), 295 (44.3%) accepted ERWPC. ERWPC acceptance was associated with clinical trial awareness (adjusted odds ratio [AOR], 1.64; 95% CI, 1.34-2.00; P < .001), prior research participation (AOR, 2.98; 95% CI, 1.23-7.24; P = .02), preference for higher effectiveness (AOR, 1.88; 95% CI, 1.17-3.04; P = .01), tolerance for nonstandard consent (AOR, 0.43; 95% CI, 0.31-0.60; P < .001), and lower likelihood of consistent chooser status (AOR, 0.22; 95% CI, 0.16-0.33; P < .001). In contrast, willingness to join a standard RCT was associated with arrhythmia (AOR, 2.15; 95% CI, 1.04-4.48; P = .04) and dyslipidemia (AOR, 1.79; 95% CI, 1.02-3.16; P = .04), awareness of clinical trials (AOR, 2.10; 95% CI, 1.69-2.61; P < .001), and effectiveness utility (AOR, 1.49; 95% CI, 1.01-2.14; P = .046) but not informed consent utility. In this survey study, ERWPC acceptance was substantial and associated with benefit-risk considerations and research familiarity. Differences in factors associated with ERWPC acceptance and standard RCT willingness suggest that emergency research responses cannot be attributed to general attitudes toward RCT participation.