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Pediatric Ethics

The FDA works to assure all clinical trials involving FDA-regulated products and enrolling children are scientifically sound and ethically appropriate. The agency works closely with stakeholders to address ethical issues raised in the development and use of medical products in newborns, infants, children and adolescents. For example, the agency: 

  • Supports medical product reviews by evaluating ethical issues in pediatric medical product development
  • Assesses reports of potential pediatric ethics violations in FDA-regulated research from external stakeholders
  • Trains staff across the agency and provides expertise to external stakeholders on ethical issues in pediatric medical product development
  • Explores ethical issues raised by pediatric studies required or requested under federal laws including the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act

Additional safeguards for children in clinical investigations

Under FDA regulations, children are afforded additional protections when participating in clinical trials. These regulations restrict the level of risk to which children may be exposed unless those risks are justified by the prospect of direct clinical benefit. The regulations also require investigators to obtain caregiver permission and, when appropriate, child assent to participate in research.

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