CFR section
21 CFR 50.25(a)(4): 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)(4) |
|---|---|
| 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) | (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. |
At a glance
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- 1–9 Warning letters citing this section
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About CFR sections cited by the FDA
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.