CFR section
21 CFR 56.111(a)(1): Criteria for IRB approval of research
PART 56-INSTITUTIONAL REVIEW BOARDS · Subpart C-IRB Functions and Operations
Key facts
| Citation | 21 CFR 56.111(a)(1) |
|---|---|
| Section | Criteria for IRB approval of research |
| Part | PART 56-INSTITUTIONAL REVIEW BOARDS |
| Subpart | Subpart C-IRB Functions and Operations |
| Subchapter | 21 CFR A General |
| Product types cited | General |
| Regulation text (excerpt) | (1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.