Emergency Care Research and Exception from Informed Consent: Addressing the Spectrum of Capacity for Consent

Area of Science:

• Bioethics
• Clinical Research Ethics
• Emergency Medicine Research

Background:

• Exception From Informed Consent (EFIC) research presents unique ethical and practical challenges.
• Existing EFIC experience primarily involves conditions where no patient consent is possible (e.g., cardiac arrest).
• Gaps exist in addressing EFIC in emergency settings where patient capacity varies, impacting enrollment decisions.

Purpose of the Study:

• To examine thresholds for determining impracticability of informed consent in emergency research.
• To explore strategies for engaging patients and surrogates when full informed consent is not feasible.
• To provide guidance on ethical conduct of EFIC studies across a spectrum of patient capacity.

Main Methods:

• Analysis of challenges in Exception From Informed Consent (EFIC) research derived from a National Institutes of Health workshop.
• Discussion of patient-level and population-level considerations for determining informed consent impracticability.
• Review of evidence and strategies for prospective engagement of patients and surrogates in emergency research.

Main Results:

• Argues against fixed criteria for justifying EFIC enrollment, emphasizing patient and population context.
• Highlights the importance of providing opportunities for patients/surrogates to decline participation when possible.
• Underscores the need for empirical evaluation of methods to operationalize prospective engagement in EFIC studies.

Conclusions:

• Determining the necessity of EFIC requires nuanced consideration of consent impracticability and patient capacity.
• Engaging patients and surrogates to allow for declining participation is ethically important when feasible.
• Further research and strategy sharing are needed to optimize the ethical conduct of emergency care research under Exception From Informed Consent.