Personal Public Disclosure: A New Paradigm for Meeting Regulatory Requirements Under Exception From Informed Consent

Area of Science:

• Clinical Trials
• Bioethics
• Public Health

Background:

• Exception From Informed Consent (EFIC) regulations require public disclosure for emergency research.
• Informed consent is crucial for patient autonomy in clinical research.
• Balancing research needs with ethical considerations is paramount in critical care settings.

Purpose of the Study:

• To describe and evaluate a novel "personal public disclosure" approach for EFIC requirements in pediatric intensive care units (PICUs).
• To assess the feasibility and impact of in-person or phone notification on patient/family autonomy and trial enrollment.

Main Methods:

• A single-arm intervention study was conducted in a pediatric intensive care unit (PICU) at an academic children's hospital.
• The "personal public disclosure" involved study team members notifying potentially eligible families about the trial upon PICU admission.
• Families could opt out of future participation, and enrollment rates were tracked.

Main Results:

• Over 16 months, 1577 families were contacted; 30% opted out.
• Only 14% of patients experiencing the critical event were enrolled, with 69% of missed enrollments due to the event occurring before disclosure.
• All 9 enrolled patients agreed to continue data collection.

Conclusions:

• Personal public disclosure can support patient/family autonomy in EFIC trials.
• The approach demonstrated limitations in cost-effectiveness, feasibility, and appropriateness due to rapid clinical events and opt-out rates.