21 CFR 56.108
IRB functions and operations
21 CFR 56.108 is the regulation titled “IRB functions and operations” in 21 CFR Part 56, Institutional Review Boards. Since 2021, 4 FDA warning letters have cited it.
- Letters citing it
- 4 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 56.115, in 4 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 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 56.108 most often, as written in the letters.
- 1 letterFailure of the IRB to prepare, maintain, and follow required written procedures raises concerns about the adequacy of the IRB's review processes for ensuring the protection of the rights and welfare of human research…
The regulation
Read the text of 21 CFR 56.108 (eCFR, as of Sep 1, 2026)
In order to fulfill the requirements of these regulations, each IRB shall:
(a) Follow written procedures: (1) For conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (2) for determining which projects require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review; (3) for ensuring prompt reporting to the IRB of changes in research activity; and (4) for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects.
(b) Follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Food and Drug Administration of: (1) Any unanticipated problems involving risks to human subjects or others; (2) any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB; or (3) any suspension or termination of IRB approval.
(c) Except when an expedited review procedure is used (see § 56.110), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.
[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, 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 56.108.
Latest letters citing it
The 3 letters citing 21 CFR 56.108 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
- DrugsView New York State Psychiatric Institute IRBInstitutional Review Board (IRB) procedures for the protection of human subjectsIssuedMar 21, 2024PostedMar 26, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.