CFR section
21 CFR 50.20: General requirements for informed consent
PART 50-PROTECTION OF HUMAN SUBJECTS · Subpart B-Informed Consent of Human Subjects
Key facts
| Citation | 21 CFR 50.20 |
|---|---|
| Section | General requirements for informed consent |
| Part | PART 50-PROTECTION OF HUMAN SUBJECTS |
| Subpart | Subpart B-Informed Consent of Human Subjects |
| Subchapter | 21 CFR A General |
| Product types cited | Biologics, Devices, Drugs, General, Other_Regulations |
| Regulation text (excerpt) | Except as provided in §§ 50.22, 50.23, and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the… |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.