CFR section
21 CFR 50.24(a)(7): 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)(7) |
|---|---|
| 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) | (7) Additional protections of the rights and welfare of the subjects will be provided, including, at least: (i) Consultation (including, where appropriate, consultation carried out by the IRB) with representatives of the communities in which the clinical investigation will be conducted and from which the subjects will be drawn; (ii) Public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the… |
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