21 CFR 56.115
IRB records
21 CFR 56.115 is the regulation titled “IRB records” in 21 CFR Part 56, Institutional Review Boards. Since 2021, 5 FDA warning letters have cited it.
- Letters citing it
- 5 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 56.108, in 4 letters
- Closed out
- 20% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (4 of 5). 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 56.115 most often, as written in the letters.
- 1 letterFailure of the IRB to conduct continuing review at intervals of not less than once per year raises concerns about the adequacy of the IRB’s oversight of ongoing research that the IRB had previously approved
- 1 letterFailure to prepare and maintain adequate documentation of IRB activities [21 CFR 56.115]
The regulation
Read the text of 21 CFR 56.115 (eCFR, as of Sep 1, 2026)
(a) An institution, or where appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:
(1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.
(2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
(3) Records of continuing review activities.
(4) Copies of all correspondence between the IRB and the investigators.
(5) A list of IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution; for example: full-time employee, part-time employee, a member of governing panel or board, stockholder, paid or unpaid consultant.
(6) Written procedures for the IRB as required by § 56.108 (a) and (b).
(7) Statements of significant new findings provided to subjects, as required by § 50.25.
(b) The records required by this regulation shall be retained for at least 3 years after completion of the research, and the records shall be accessible for inspection and copying by authorized representatives of the Food and Drug Administration at reasonable times and in a reasonable manner.
(c) The Food and Drug Administration may refuse to consider a clinical investigation in support of an application for a research or marketing permit if the institution or the IRB that reviewed the investigation refuses to allow an inspection under this section.
[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991; 67 FR 9585, Mar. 4, 2002]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 56.115.
- 21 CFR 56.108IRB functions and operations4 letters cite both
- 21 CFR 56.109IRB review of research3 letters cite both
- 21 CFR 50.25Elements of informed consent2 letters cite both
- 21 CFR 56.113Suspension or termination of IRB approval of research2 letters cite both
- 21 CFR 312.66Assurance of IRB review1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 56.115 that FDA posted most recently.
- DrugsView Armstrong County Memorial HospitalInstitutional review board services for clinical investigationsIssuedOct 29, 2024PostedNov 5, 2024
- DrugsView Louisiana State University Health Science Center IRBN/AIssuedSep 27, 2024PostedOct 8, 2024
- BiologicsView Massachusetts Institute of Technology MITIRB oversight of clinical investigationsIssuedJun 21, 2024PostedJul 16, 2024
Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.