CFR section
21 CFR 56.109(e): IRB review of research
PART 56-INSTITUTIONAL REVIEW BOARDS · Subpart C-IRB Functions and Operations
Key facts
| Citation | 21 CFR 56.109(e) |
|---|---|
| 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 | Drugs, General |
| Regulation text (excerpt) | (e) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. For investigations involving an exception to informed… |
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