• Catherine E Ross, Monica E Kleinman, and Michael W Donnino.
• Division of Medical Critical Care, Department of Pediatrics, Boston Children's Hospital and Harvard Medical School, Boston, MA.
• Crit. Care Med. 2025 Feb 12.

ObjectivesTo describe a novel approach to the requirement for public disclosure under regulations for Exception From Informed Consent (EFIC) in an inpatient clinical trial.DesignSingle-arm intervention study within a clinical trial.SettingMedical and medical/surgical PICUs at an academic children's hospital.ParticipantsFamilies of children and young adults younger than 26 years old receiving care in a PICU.InterventionsAs part of a multipronged approach to meeting requirements for public disclosure for EFIC, we developed and implemented a process termed "personal public disclosure," in which a member of the study team notifies all potentially eligible patients/families in-person or by phone about the trial as soon as possible upon PICU admission. Patients/families may choose to opt out of future participation in the trial.Measurements And Main ResultsOver a 16-month period, 1577 potentially eligible patients/families were successfully contacted for personal public disclosure. Of these, 473 (30%) opted out of future participation in the trial. In the same period, 64 patients developed the emergent event of interest for the primary trial. Of these, only 9 (14%) were enrolled. Upon notification of enrollment, all 9 (100%) agreed to continue in the data collection phase of the study. Of the remaining 55 missed enrollments, 38 (69%) were due to the event occurring before personal public disclosure had been completed.ConclusionsPersonal public disclosure supports patient/family autonomy within an EFIC trial; however, this approach is limited by low cost-effectiveness, feasibility and appropriateness in many circumstances.Copyright © 2025 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.

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