Emergency consent pathways in acute ischemic stroke trials: determinants, consequences, and stakeholder attitudes-an evidence-mapping study.

backgroundTime-critical acute ischemic stroke (AIS) research often involves patients who lack decisional capacity. Emergency consent pathways can enable enrollment, but their consequences for fairness, trial conduct, and trust remain uncertain.

methodsUsing a Population–Concept–Context framework, we conducted an evidence-mapping study of published empirical research. PubMed, Scopus, Web of Science, and CINAHL were searched from inception through 31 December 2025, without language or date restrictions. We included empirical studies in AIS or other time-critical stroke trials that examined consent pathways, capacity-related barriers, stakeholder perspectives, workflow impact, or regulatory/ethics committee variation. The protocol was registered on the Open Science Framework (OSF) (registration ID: k94da; associated project: ytfj5).

resultsTen studies met the inclusion criteria. Capacity limitations were consistently associated with stroke severity and neurological deficits. Restricting enrollment to self-consent was associated with the exclusion of older and/or more severely affected patients, raising concerns about representativeness and equity. Deferred consent was generally feasible in time-critical pathways, although enrollment timing differed by consent type in some studies. Stakeholder studies reported overall support alongside concerns about autonomy, understanding, and post-enrollment communication. Regulatory evidence showed substantial cross-jurisdiction and cross-committee variability in acceptable procedures.

conclusionsEmergency consent pathways may improve inclusion of otherwise underrepresented AIS patients but can introduce selection effects and uneven safeguards. Trials should prespecify consent pathways a priori, standardize capacity assessment and reporting, and monitor representativeness and workflow outcomes.