Research covered by these regulations that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB.
21 CFR Part 56 · Institutional Review Boards
§ 56.112 Review by institution
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 § 56.112
Form FDA 483 observations citing this section, fiscal years 2018–2018 (Bioresearch Monitoring).
- Approval by institution in absence of IRB approval 1
FDA guidance that cites § 56.112
- Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs 5 Feb 2025
- CHAPTER 48 - 7348.809 Bioresearch Monitoring
Amendment history
Federal Register documents that created or amended this section.
- 46 FR 8975 27 Jan 1981