Provides information on ethical issues raised in the development and use of FDA-regulated products in infants, children and adolescents
To assure that all FDA-regulated clinical trials enrolling children are scientifically sound and ethically appropriate
What we do:
- Provide a pediatric ethics consultation service available upon request to anyone within the FDA related to any ethical issue in FDA-regulated pediatric product development
- Assess reports of potential pediatric ethics violations in FDA-regulated research from external stakeholders
- Public speaking at internal and external events by invitation, and training of FDA staff and external stakeholders on ethical issues in FDA-regulated pediatric product development
- To explore ethical issues raised by pediatric studies required under the Pediatric Research Equity Act or requested under the Best Pharmaceuticals for Children using OPT’s custom databases
- Enhancing Regulatory Oversight for Challenging Clinical Trials May 5, 2014 (PDF - 98KB)
Presentation to the 2014 annual meeting of the Pediatric Academic Societies on the appropriate understanding of research risk and risk disclosure in a clinical trial, raised by discussions of the SUPPORT study Podcast: More Than Meets the IRB
A conversation about the vulnerability of children in research, including the appropriate risk/benefit balance, the difference between high and low-risk pathways, and "equitable selection" as a criterion for IRB review of pediatric research.
- Component Analysis, February 28, 2012 (PDF - 1.3MB)
Presentation describes how each intervention or procedure in a clinical trial is evaluated to ensure compliance with FDA's pediatric ethics regulations, the Additional Safeguards for Children in Clinical Investigations (21 CFR 50 subpart D)
Ethical Considerations in Evaluating Non- Therapeutic Studies in Children (March 29,2012)(PDF - 953KB)
Describes the application of FDA's pediatric ethics regulations to low-risk studies that do not offer a direct benefit to any individual enrolled child
- More Selected Presentations
Ethical Considerations in Conducting Pediatric Research(PDF - 387KB)
A review of key ethical considerations concerning the participation of children in clinical research
- A capacity-based approach for addressing ancillary care needs: implications for research in resource limited settings
The authors propose a model for identifying ancillary care obligations that draws on assessments of urgency, the capacity of the local healthcare infrastructure and the capacity of the research infrastructure
- Is there an objective way to compare research risks?
The authors review some philosophical problems with the systematic evaluation of research risks framework, and suggest that a deliberative approach may be a more viable candidate for future development.
- More Selected Publications
Advisory Committee Meetings and Workshops
- Transcript for Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures, February 15-16, 2012
An exploration of scientific and ethical issues involved in the development of pediatric products for preparedness for chemical, biological, radiological, or nuclear threats
- Pediatric Ethics Subcommittee of the Pediatric Advisory Committee, May 2011
Exploratory IND Studies in the Pediatric Population
- More Advisory Committee Meetings and Workshops
- Guidance for Industry Acute Bacterial Otitis Media: Developing Drugs for Treatment (PDF - 117KB)
FDA draft guidance to assist sponsors in the clinical development of drugs for the treatment of acute bacterial otitis media
- Additional Safeguards for Children in Clinical Investigations
FDA published the final rule on 21 CFR 50 subpart D on February 29, 2013. Among other topics, the preamble contains a discussion of the analysis of placebo controlled trials, including the use of component analysis.