21 CFR Part 50 - Protection of Human Subjects

What it says

Part 50 sets requirements for informed consent in clinical investigations regulated by FDA, including the elements of consent, documentation, the obligation to obtain consent before a subject is enrolled, and additional safeguards for children and other vulnerable groups. Consent must be given in language understandable to the subject and must not include language that waives legal rights.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Consent is a process as well as a signed form, and the person must have time to consider participation.
• The consent form content must be approved by the IRB before use, and changes need re-approval.
• Signed forms must be on file for each enrolled subject.

What FDA inspectors look for

• Whether each subject signed the current IRB-approved consent form before study procedures.
• Whether all required elements are included.
• Whether consent was documented properly, including dates and the person obtaining it.

Related regulations