21 CFR 312.66
Assurance of IRB review
21 CFR 312.66 is the regulation titled “Assurance of IRB review” in 21 CFR Part 312, Investigational New Drug Application. Since 2021, 8 FDA warning letters have cited it.
- Letters citing it
- 8 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 312.60, in 5 letters
- Closed out
- 13% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (7 of 8). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 312.66 most often, as written in the letters.
- 1 letterYou failed to assure that an Institutional Review Board (IRB) that complies with the requirements set forth in 21 CFR part 56 was responsible for the initial and continuing review and approval of the proposed clinical…
- 1 letterYou failed to assure that an Institutional Review Board (IRB) that complies with the requirements set forth in part 56 was responsible for the initial and continuing review and approval of the proposed clinical study…
- 1 letterYou failed to ensure that an Institutional Review Board (IRB) that complies with the requirements set forth in 21 CFR part 56 was responsible for the initial and continuing review and approval of the proposed clinical…
The regulation
Read the text of 21 CFR 312.66 (eCFR, as of Sep 1, 2026)
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]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 312.66.
- 21 CFR 312.60General responsibilities of investigators5 letters cite both
- 21 CFR 312.62Investigator recordkeeping and record retention2 letters cite both
- 21 CFR 56.109IRB review of research2 letters cite both
- 21 CFR 312.2Applicability1 letter cites both
- 21 CFR 312.20Requirement for an IND1 letter cites both
- 21 CFR 312.305Requirements for all expanded access uses1 letter cites both
- 21 CFR 312.310Individual patients, including for emergency use1 letter cites both
- 21 CFR 312.33Annual reports1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 312.66 that FDA posted most recently.
- DrugsView Ralph A. DeFronzo, M.D.investigational drugs (b)(4)IssuedSep 17, 2025PostedSep 23, 2025
- BiologicsView Namita A. Goyal, M.D.investigational product for ALS studyIssuedOct 10, 2024PostedOct 22, 2024
- DrugsView Louisiana State University Health Science Center IRBN/AIssuedSep 27, 2024PostedOct 8, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.