Pediatric Ethics
Provides information on ethical issues raised in the development and use of FDA-regulated products in infants, children and adolescents
Our Mission:
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
Selected Presentations
- Ethical Challenges in Clinical Trial Design Lessons Learned from DMD November 29, 2016
- Ethical Considerations in the Design and Conduct of Clinical Lactation Studies November 16, 2016
- Risky Business: Exposing Children to Potential Harm Without Compensating Clinical Benefit November 15, 2016
- Enhancing Regulatory Oversight for Challenging Clinical Trials May 5, 2014
- More Selected Presentations
Selected Publications
- Ethical Considerations in Conducting Pediatric Research
- A capacity-based approach for addressing ancillary care needs: implications for research in resource limited settings
- Is there an objective way to compare research risks?
- 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
- Pediatric Ethics Subcommittee of the Pediatric Advisory Committee, May 2011
- Public Workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations
- More Advisory Committee Meetings and Workshops