Pediatric Ethics
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
- Explore ethical issues raised by pediatric studies required under the Pediatric Research Equity Act or requested under the Best Pharmaceuticals for Children Act
Resources for You
- Additional Safeguards for Children in Clinical Investigations
- Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations
- Office for Human Research Protections