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

Personal Public Disclosure: A New Paradigm for Meeting Regulatory Requirements Under Exception From Informed Consent
Research Report
Catherine E. Ross, Monica E. Kleinman, Michael W. Donnino
Critical Care Medicine, 12 February 2025
Abstract
Objectives
To describe a novel approach to the requirement for public disclosure under regulations for Exception From Informed Consent (EFIC) in an inpatient clinical trial.
Design
Single-arm intervention study within a clinical trial.
Setting
Medical and medical/surgical PICUs at an academic children’s hospital.
Participants
Families of children and young adults younger than 26 years old receiving care in a PICU.
Interventions
As 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 Results
Over 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.
Conclusions
Personal 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.