CFR section
21 CFR 56.109(h): IRB review of research
PART 56-INSTITUTIONAL REVIEW BOARDS · Subpart C-IRB Functions and Operations
Key facts
| Citation | 21 CFR 56.109(h) |
|---|---|
| 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) | (h) When some or all of the subjects in a study are children, an IRB must determine that the research study is in compliance with part 50, subpart D of this chapter, at the time of its initial review of the research. When some or all of the subjects in a study that was ongoing on April 30, 2001, are children, an IRB must conduct a review of the research to determine compliance with part 50, subpart D of this chapter, either at the time of continuing review or, at the discretion of the IRB, at an… |
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