ArticleCritical care medicine2025
Personal Public Disclosure: A New Paradigm for Meeting Regulatory Requirements Under Exception From Informed Consent.
Article in Critical care medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
3 authors.
Funding
Abstract
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.
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