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

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

SUBMITTER: Ross CE 

PROVIDER: S-EPMC12499905 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature