Protection of Human Subjects (Informed Consent)
The US regulation setting the requirements for informed consent of human subjects in FDA-regulated clinical investigations, including the elements of consent, its documentation, and additional safeguards for vulnerable populations such as children (Subpart D).
All FDA-regulated clinical investigations involving human subjects. Works in tandem with 21 CFR Part 56 (IRBs) and Part 312 (IND).
- 01Obtain legally effective informed consent before any trial-specific procedure
- 02Include all required elements, including the concise key-information summary
- 03Document consent with a signed and dated form using the IRB-approved version
- 04Apply additional protections for children and other vulnerable subjects
Harmonised with the revised Common Rule ("key information" summary) following the 2017-2018 updates.
21 CFR Part 50: frequently asked questions
Quick answers to common questions about 21 CFR Part 50.
What is 21 CFR Part 50?
21 CFR Part 50 — Protection of Human Subjects (Informed Consent) — is a regulation issued by the Food and Drug Administration (United States). The US regulation setting the requirements for informed consent of human subjects in FDA-regulated clinical investigations, including the elements of consent, its documentation, and additional safeguards for vulnerable populations such as children (Subpart D).
Who does 21 CFR Part 50 apply to?
All FDA-regulated clinical investigations involving human subjects. Works in tandem with 21 CFR Part 56 (IRBs) and Part 312 (IND).
What are the key requirements of 21 CFR Part 50?
FDA 21 CFR Part 50 requires, among other things: Obtain legally effective informed consent before any trial-specific procedure; Include all required elements, including the concise key-information summary; Document consent with a signed and dated form using the IRB-approved version; Apply additional protections for children and other vulnerable subjects.
When was 21 CFR Part 50 last updated?
The current version of 21 CFR Part 50 dates from January 2024. Harmonised with the revised Common Rule ("key information" summary) following the 2017-2018 updates.
Track the standards that move
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