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21 CFR Part 312 · Investigational New Drug Application

§ 312.66 Assurance of IRB review

Subpart D - Responsibilities of Sponsors and Investigators Official text on eCFR Amendment history

An investigator shall assure that an IRB that complies with the requirements set forth in part 56 will be responsible for the initial and continuing review and approval of the proposed clinical study. The investigator shall also assure that he or she will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects or others, and that he or she will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.

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 § 312.66

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Bioresearch Monitoring).

  • Unanticipated problems 139
  • Changes in research 87
  • Initial and continuing review 80

Warning letters citing § 312.66

9 FDA warning letters since 2017 cite this section :

FDA guidance that cites § 312.66

Amendment history

Federal Register documents that created or amended this section.