What 21 CFR Part 50 - Protection of Human Subjects requires
Organizations conducting clinical investigations involving human subjects must obtain and document informed consent, adhering to specific required elements and implementing additional safeguards for vulnerable populations such as children.
Pillar: Medical & Healthcare · Authority: U.S. Food and Drug Administration · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50
SHA-256 integrity: d6be683c65b2787baac24319c2397df97f7c3d54e334fbc818fc4740700e510b
Primary Citations — 7 traced to source
- § 50.20 General requirements for informed consent.
- § 50.25 Elements of informed consent.
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