Related Experiment Video
Updated: May 28, 2025
Working with Human Tissues for Translational Cancer Research
Published on: November 26, 2015
Personal Public Disclosure: A New Paradigm for Meeting Regulatory Requirements Under Exception From Informed Consent
Catherine E Ross1,2, Monica E Kleinman3, Michael W Donnino2,4
1Division of Medical Critical Care, Department of Pediatrics, Boston Children's Hospital and Harvard Medical School, Boston, MA.
Insights
Personal public disclosure in Exception From Informed Consent (EFIC) trials respects autonomy but faces challenges. Many families opted out, and rapid clinical events limited enrollment effectiveness.
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.
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.
More Related Videos
08:42A Familiarization Protocol Facilitates the Participation of Children with ASD in Electrophysiological Research
Published on: July 31, 2017
08:53Integrating Computerized Linguistic and Social Network Analyses to Capture Addiction Recovery Capital in an Online Community
Published on: May 31, 2019
Related Concept Videos
01:23Ethical Standards II
Nurses are entrusted with upholding various ethical principles and standards. Nurses forge solid therapeutic relationships using trust, empathy, autonomy, confidentiality, and professional competence.
Confidentiality is crucial, embodying respect for individual privacy...
01:19Standards of Care II
01:22Ethics and Bioethics
01:25Ethical Standards I
The Code of Ethics provisions outline the nurse's duty to the patient, the healthcare team, the profession, and society. The Code's fundamental principles include advocacy,...
01:06Legal Guidelines for Documentation
01:27Nursing Ethical Principles II
Consider the following scenario, which illustrates how these principles are applied in the care of Mr. John, a fifty-year-old teacher diagnosed with metastatic liver cancer.
Initially, Mr. John's...