Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.113
From GxPlex
| Document information | |
|---|---|
| Reference | USA 45 CFR Part 46 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 45 CFR Part 46 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 45—Public Welfare
Subtitle A—Department of Health and Human Services Subchapter A—General Administration Part 46 Protection of Human Subjects https://www.ecfr.gov/current/title-45 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 6 — Unit 6.1.2 |
| Scope | G |
| Document part | § 46.113 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Withdrawal of ethics approval, Ethics committee, Requirements |
| Comment | IRB authority to suspend or terminate approval of research |
Content
§ 46.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.
