21 CFR § 312.66 - Assurance of IRB review.

---
identifier: "/us/cfr/t21/s312.66"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 312.66 - Assurance of IRB review."
title_number: 21
title_name: "Food and Drugs"
section_number: "312.66"
section_name: "Assurance of IRB review."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "312"
part_name: "INVESTIGATIONAL NEW DRUG APPLICATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262."
regulatory_source: "52 FR 8831, Mar. 19, 1987, unless otherwise noted."
cfr_part: "312"
---


# 312.66 Assurance of IRB review.

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.

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 FR 9586, Mar. 4, 2002]