Subpart D classifies pediatric research by risk and prospect of benefit (46.404–46.407). Higher-risk research without direct benefit requires national-level review under 46.407. Permission of one or both parents and child assent are determined by the IRB based on age, maturity, and risk.
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Glossary Term
45 CFR 46 Subpart D
Regulatory
Also known as: Subpart D, pediatric research protections, children in research
Additional protections for children involved in research, including parental permission and assent requirements.
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