CFR section
21 CFR 56.109(b): IRB review of research
PART 56-INSTITUTIONAL REVIEW BOARDS · Subpart C-IRB Functions and Operations
Key facts
| Citation | 21 CFR 56.109(b) |
|---|---|
| Section | IRB review of research |
| Part | PART 56-INSTITUTIONAL REVIEW BOARDS |
| Subpart | Subpart C-IRB Functions and Operations |
| Subchapter | 21 CFR A General |
| Product types cited | Devices, General |
| Regulation text (excerpt) | (b) An IRB shall require that information given to subjects as part of informed consent is in accordance with § 50.25. The IRB may require that information, in addition to that specifically mentioned in § 50.25, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects. |
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