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A Framework for Exception From Informed Consent in Trials Enrolling Patients With ST-Segment-Elevation Myocardial
Graham Nichol1, Neal W Dickert2, Jacob E Moeller3
1University of Washington-Harborview Center for Prehospital Emergency Care Seattle WA.
Insights
Acute ST-segment-elevation myocardial infarction with cardiogenic shock (AMI-CS) research can use exception from informed consent (EFIC) in the US. This approach allows timely enrollment for life-saving treatments when consent is not feasible.
Area of Science:
- Cardiology
- Clinical Research Ethics
Background:
- Cardiogenic shock (CS) results in critical end-organ hypoperfusion due to reduced cardiac output.
- Acute ST-segment-elevation myocardial infarction with CS (AMI-CS) is associated with high mortality.
- Clinical trials in AMI-CS patients face challenges due to consent issues and urgent treatment needs.
Purpose of the Study:
- To provide a rationale for conducting clinical trials in AMI-CS patients using exception from informed consent (EFIC) in the United States.
- To address the feasibility and ethical considerations of enrolling AMI-CS patients under EFIC.
- To propose a framework for implementing EFIC in AMI-CS trials, balancing subject protection and research necessity.
Main Methods:
- Review of US human subject regulations for EFIC criteria.
- Comparison of therapeutic windows and consent feasibility between AMI-CS and out-of-hospital cardiac arrest (OHCA) trials.
- Proposal of a specific enrollment protocol including a therapeutic initiation window and consent seeking timeline.
Main Results:
- AMI-CS trials can potentially meet EFIC criteria due to the life-threatening nature of the condition, unsatisfactory treatments, and the necessity for valid evidence.
- Obtaining informed consent is often impractical in AMI-CS, and EFIC enrollment could enhance generalizability.
- A proposed 30-minute window for intervention initiation with 15-minute consent seeking respects patient autonomy while enabling research.
Conclusions:
- Exception from informed consent (EFIC) is a viable and ethical approach for clinical trials in acute ST-segment-elevation myocardial infarction with cardiogenic shock (AMI-CS).
- Implementing EFIC in AMI-CS trials can accelerate the generation of crucial evidence to improve patient care.
- Successful application of EFIC in AMI-CS research can inform future trials in critical cardiovascular conditions.
Abstract:
Cardiogenic shock (CS) is critical end-organ hypoperfusion attributable to reduced cardiac output. Acute ST-segment-elevation myocardial infarction with CS (AMI-CS) has high mortality. Clinical research is challenging in such patients as they often cannot provide consent, lack available legal representatives, and require initiation of therapy. Multiple trials have enrolled patients with AMI-CS outside the United States under deferred consent. Trials in the United States have enrolled patients with out-of-hospital cardiac arrest under exception from informed consent (EFIC). However, AMI-CS has a longer therapeutic window to initiate treatment than out-of-hospital cardiac arrest, and more patients or their representatives can engage in treatment decisions. We provide a rationale for how a trial enrolling patients with AMI-CS could qualify for conduct using EFIC by meeting each criterion specified in US human subject regulations. AMI-CS is a life-threatening situation, available treatments are unsatisfactory, and collection of valid evidence is necessary. Obtaining informed consent is often not feasible, and trial participation could benefit subjects. Only enrolling consented patients is impracticable and could reduce the study's generalizability. We propose a therapeutic window of 30 minutes within the study intervention must be initiated, with consent sought within 15 minutes, respecting any refusal or objection to enrollment, and otherwise enrollment under EFIC. A trial could enroll patients with AMI-CS under EFIC and can involve both patients and their representatives. Successful use of EFIC in trials of other interventions in patients with CS or enrolling patients with other acute cardiovascular conditions could increase the available evidence base to improve care.
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