CFR section
21 CFR 50.24(a)(2): Exception from informed consent requirements for emergency research
PART 50-PROTECTION OF HUMAN SUBJECTS · Subpart B-Informed Consent of Human Subjects
Key facts
| Citation | 21 CFR 50.24(a)(2) |
|---|---|
| Section | Exception from informed consent requirements for emergency research |
| Part | PART 50-PROTECTION OF HUMAN SUBJECTS |
| Subpart | Subpart B-Informed Consent of Human Subjects |
| Subchapter | 21 CFR A General |
| Product types cited | General |
| Regulation text (excerpt) | (2) Obtaining informed consent is not feasible because: (i) The subjects will not be able to give their informed consent as a result of their medical condition; (ii) The intervention under investigation must be administered before consent from the subjects' legally authorized representatives is feasible; and (iii) There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation. |
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