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 Food and Drug Administration.
21 CFR Part 56 · Institutional Review Boards
§ 56.113 Suspension or termination of IRB approval of research
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 56.113
Form FDA 483 observations citing this section, fiscal years 2009–2023 (Bioresearch Monitoring).
- Reporting 22
- Authority of the IRB 1
- Statement of reasons 1
Warning letters citing § 56.113
2 FDA warning letters since 2017 cite this section :
- Louisiana State University Health Science Center IRB 27 Sept 2024
- New York State Psychiatric Institute IRB 21 Mar 2024
FDA guidance that cites § 56.113
- Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs 5 Feb 2025
- Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs 25 Sept 2017
- Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors 23 May 2014
- IRB Continuing Review After Clinical Investigation Approval: Guidance for IRBs, Clinical Investigators, and Sponsors 27 Feb 2012
- CHAPTER 48 - 7348.809 Bioresearch Monitoring
Amendment history
Federal Register documents that created or amended this section.
- 46 FR 8975 27 Jan 1981