Scoping review maps consent pathways in time-critical heart attack research

When someone is having a heart attack, the minutes spent obtaining written research consent can collide directly with the urgency of restoring blood flow. A new scoping review with systematic evidence mapping, published in BMC Medical Ethics, has now charted what is actually known about consent and enrolment procedures in time-critical acute myocardial infarction (AMI) research, and the authors conclude that the existing evidence does not support declaring any single consent pathway preferable across all such trials.

The review team, led by Tao Zhou with colleagues including Ganying Huang, searched PubMed, Embase, CINAHL, Scopus and Web of Science Core Collection from inception through 2 August 2026, with three broader validation searches using the same publication-date cutoff conducted on 15 October 2026. Both the original and revision-stage searches were restricted to English-language records. Two reviewers independently screened records and full texts and independently coded pathway and context–domain contributions, following a Population–Concept–Context framework and PRISMA-ScR where applicable. The work was registered on the Open Science Framework.

The search identified fifteen eligible reports published between 1999 and 2023, and the revision-stage validation searches found no additional eligible study. The evidence base is strikingly narrow given how often emergency cardiac trials raise consent dilemmas: research enrolment in AMI may occur while patients remain symptomatic and reperfusion is still being arranged, which constrains conventional prospective written consent.

Within that limited corpus, the mapped evidence concentrated on two areas: research decision-making and information processing, and patient or clinician perspectives on involvement. The studies assessed distinct constructs, including cognitive performance, comprehension, recall, perceived ability to decide, voluntariness, and preference for involvement. The review’s authors stress that these consent-related constructs and evidence types should remain distinct, since comprehension measured in one setting does not automatically translate into conclusions about a different authorization procedure.

Some studies went beyond preferences and hypotheticals. Oral, verbal-assent, and staged consent procedures were implemented in selected settings, offering real-world examples of alternative authorization routes. However, much of the remaining evidence concerned preferences, experiences, or hypothetical scenarios rather than direct comparisons between pathways, which limits how far the findings can guide trial design.

Workflow data were similarly sparse and indirect. Two observational studies reported longer reperfusion intervals associated with overall trial-enrolment processes, but neither study isolated consent-specific time. The review’s conclusions are careful on this point: observed workflow differences cannot be attributed specifically to consent, because the enrolment process involves many steps beyond the consent conversation itself.

Other gaps stand out. Direct evidence on participant selection was limited, and no eligible report evaluated AMI-specific exception-from-informed-consent (EFIC) outcomes or directly compared regulatory practice across jurisdictions.

The authors’ conclusion is deliberately restrained. The evidence identified does not provide a basis for identifying one research-consent pathway as preferable across all time-critical AMI trials, and comparative evidence on authorization procedures remains limited. Rather than endorsing oral consent, staged consent, or any other model, the review frames the field as one where descriptive and preference-based findings have accumulated without the head-to-head comparisons that would settle practical questions.

Looking forward, the review recommends that future AMI trials prespecify their authorization pathways and prospectively assess understanding, involvement, workflow, and participant selection within the applicable ethical and regulatory framework. In other words, consent procedures should be treated as study outcomes in their own right, measured and reported rather than assumed. As a scoping review with systematic evidence mapping, the study describes what has been studied and where the gaps lie; it does not itself test any consent procedure, and its findings are bounded by the fifteen English-language reports published between 1999 and 2023 that met its eligibility criteria.

Subject of Research: Consent and enrolment procedures in time-critical acute myocardial infarction research

Article Title: Informed and alternative consent pathways in time-critical acute myocardial infarction research: decision-making capacity, participant perspectives, and operational feasibility—a scoping review with systematic evidence mapping

Article References: Zhou, T., Wang, H., Jiang, S., Zhou, Q., & Huang, G. (2026). Informed and alternative consent pathways in time-critical acute myocardial infarction research: decision-making capacity, participant perspectives, and operational feasibility—a scoping review with systematic evidence mapping. BMC Medical Ethics. https://doi.org/10.1186/s12910-026-01663-5

Image Credits: AI Generated

DOI: 10.1186/s12910-026-01663-5

Keywords: acute myocardial infarction, informed consent, scoping review, research ethics, EFIC, emergency research, reperfusion, decision-making capacity, verbal assent, trial enrolment, BMC Medical Ethics, Informed