Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.110 (b) (2)
From GxPlex
| Document information | |
|---|---|
| Reference | USA 21 CFR Part 56 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 21 CFR Part 56 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 21 —Food and Drugs
Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 56 Institutional Review Boards https://www.ecfr.gov/current/title-21 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 — Unit 4.4.0 |
| Scope | G |
| Document part | § 56.110
(b) (2) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Amendment, Ethics committee, Risk classification, FDA |
Content
§ 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. […] (b) An IRB may use the expedited review procedure to review either or both of the following: [...] (2) minor changes in previously approved research during the period (of 1 year or less) for which approval is authorized. Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the IRB chairperson from among the members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the nonexpedited review procedure set forth in § 56.108(c). [...]
