In a Japanese survey study, 60.5% of respondents accepted emergency research without prior consent in at least one hyperacute stroke scenario, and acceptance was associated with benefit-risk considerations and research familiarity rather than general attitudes toward RCT participation.
Key Findings
Results
A majority of survey respondents accepted emergency research without prospective consent (ERWPC) in at least one hypothetical hyperacute stroke scenario.
605 of 1000 respondents (60.5%) accepted ERWPC, defined as selecting 'willing' or 'rather willing' to participate in at least 1 scenario without prospective consent.
In contrast, only 334 of 1000 respondents (33.4%) were willing to join a standard RCT requiring prospective informed consent.
The survey was conducted in 2024 using a commercial opt-in panel of adults aged 20–79 years residing in Japan, with equal allocation across age-by-sex strata (n=1000; mean [SD] age, 50.1 [15.6] years; 500 females [50.0%]).
Participants completed 8 conjoint scenarios with varying effectiveness, adverse event risk, and consent modality.
Results
A substantial proportion of people unwilling to join a standard RCT still accepted ERWPC.
Among the 666 respondents unwilling to join a standard RCT, 295 (44.3%) nonetheless accepted ERWPC.
This finding suggests that emergency research responses cannot be attributed to general attitudes toward RCT participation.
The authors interpreted this divergence as indicating distinct decision-making processes for emergency versus standard research contexts.
Results
Clinical trial awareness and prior research participation were independently associated with ERWPC acceptance.
Clinical trial awareness was associated with ERWPC acceptance (AOR, 1.64; 95% CI, 1.34–2.00; P < .001).
Prior research participation was strongly associated with ERWPC acceptance (AOR, 2.98; 95% CI, 1.23–7.24; P = .02).
These factors reflect 'research familiarity' as a driver of acceptance.
Results
Preference for higher treatment effectiveness and tolerance for nonstandard consent were independently associated with ERWPC acceptance.
Preference for higher effectiveness was positively associated with ERWPC acceptance (AOR, 1.88; 95% CI, 1.17–3.04; P = .01).
Tolerance for nonstandard consent was inversely coded and negatively associated with ERWPC acceptance (AOR, 0.43; 95% CI, 0.31–0.60; P < .001), meaning lower tolerance for nonstandard consent reduced acceptance.
Lower likelihood of consistent chooser status was also negatively associated with ERWPC acceptance (AOR, 0.22; 95% CI, 0.16–0.33; P < .001).
These results indicate that benefit-risk considerations influenced ERWPC acceptance.
Results
Factors associated with willingness to join a standard RCT differed from those associated with ERWPC acceptance, including comorbidities and no role for informed consent utility.
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 was also associated with standard RCT willingness (AOR, 2.10; 95% CI, 1.69–2.61; P < .001).
Effectiveness utility was associated with standard RCT willingness (AOR, 1.49; 95% CI, 1.01–2.14; P = .046), but informed consent utility was not.
In contrast, ERWPC acceptance was not similarly associated with comorbidities, highlighting distinct predictors between the two outcomes.
Background
The study was conducted in Japan, a country lacking established regulatory or ethical pathways for emergency research without prospective consent.
The authors noted that 'little is known about public acceptance of ERWPC in countries lacking established pathways.'
International ethics guidance recognizes that enrollment without prior consent may be permissible in time-sensitive emergencies such as hyperacute ischemic stroke.
The Japanese context was highlighted as a gap, motivating this survey study.
What This Means
This research suggests that a majority of Japanese adults (about 60%) would be willing to participate in emergency medical research without giving prior consent, at least under some circumstances involving a hyperacute stroke scenario. Notably, many people who said they would not want to join a conventional clinical trial still accepted the idea of being enrolled in emergency research without advance permission, suggesting that these are two distinct decisions driven by different factors.
The study found that people were more likely to accept emergency research without prior consent if they were already familiar with clinical trials, had previously participated in research, valued higher treatment effectiveness, and were more tolerant of non-standard consent procedures. By contrast, willingness to join a standard trial was more influenced by having certain health conditions like arrhythmia or high cholesterol. These different predictors suggest that how someone feels about emergency research is not simply a reflection of their general attitude toward medical research.
This matters because stroke is a medical emergency where time is critical and obtaining formal consent before treatment or research may not be possible. Many countries, including Japan at the time of this study, lack clear rules allowing researchers to enroll patients in such trials without upfront consent. This research suggests there is meaningful public openness to emergency research without prior consent in Japan, and that public education about clinical trials could further increase acceptance, which could inform future policy and ethical guidelines around emergency research.
Suzuki M, Fukuda-Doi M, Yamamoto H, Minami M, Ishigami A, Hirase K, et al.. (2026). Public Acceptance of Emergency Research Without Prior Consent in Stroke.. JAMA network open. https://doi.org/10.1001/jamanetworkopen.2026.17347