CFR section
21 CFR 50.25(a)(1): Elements of informed consent
PART 50-PROTECTION OF HUMAN SUBJECTS · Subpart B-Informed Consent of Human Subjects
Key facts
| Citation | 21 CFR 50.25(a)(1) |
|---|---|
| Section | Elements of 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 | Devices, Drugs, General |
| Regulation text (excerpt) | (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental. |
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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.