Children in Research

When a proposed research study involves children and is supported or conducted by HHS, the research institution's Institutional Review Board (IRB) must take into consideration the special regulatory requirements that provide additional protection for the children who would be involved in the research. If the proposed research involves FDA-regulated products, then FDA's parallel regulations apply.

Related Documents

Protections for Children in Research: A Report to Congress

  • Children's Health Act of 2000 [PDF - 111KB]

Research Proposals Previously Reviewed under 45 CFR 46.407


Last revised: November 25, 2008