Glossary Term

21 CFR 50

Regulatory

Also known as: 21 CFR Part 50, FDA informed consent regulations

FDA regulations governing the protection of human subjects, including informed consent and additional safeguards for children.

21 CFR Part 50 codifies FDA's informed consent requirements (50.20–50.27) and pediatric protections (Subpart D, 50.50–50.56). It applies whenever the study supports an FDA submission for a regulated product.

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