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.
Protections for Children in Research: A Report to Congress
Research Proposals Previously Reviewed under 45 CFR 46.407
Last revised: November 25, 2008