21 CFR 56.109
IRB review of research
21 CFR 56.109 is the regulation titled “IRB review of research” in 21 CFR Part 56, Institutional Review Boards. Since 2021, 6 FDA warning letters have cited it.
- Letters citing it
- 6 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 3 letters
- Closed out
- 17% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (5 of 6). 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 56.109 most often, as written in the letters.
- 1 letterYou failed to obtain informed consent and assent of children in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60, 21 CFR 50.20, 21 CFR 50.27, and 21 CFR 50.55]
- 1 letterYou failed to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR 50.27(a)]
- 1 letterYou failed to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60; 21 CFR 50.20; 21 CFR 50.27; 21 CFR 50.52; 21 CFR 50.55]
The regulation
Read the text of 21 CFR 56.109 (eCFR, as of Sep 1, 2026)
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by these regulations.
(b) An IRB shall require that information given to subjects as part of informed consent is in accordance with § 50.25. The IRB may require that information, in addition to that specifically mentioned in § 50.25, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
(c) An IRB shall require documentation of informed consent in accordance with § 50.27 of this chapter, except as follows:
(1) The IRB may, for some or all subjects, waive the requirement that the subject, or the subject's legally authorized representative, sign a written consent form if it finds that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context; or
(2) The IRB may, for some or all subjects, find that the requirements in § 50.24 of this chapter for an exception from informed consent for emergency research are met.
(d) In cases where the documentation requirement is waived under paragraph (c)(1) of this section, the IRB may require the investigator to provide subjects with a written statement regarding the research.
(e) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. For investigations involving an exception to informed consent under § 50.24 of this chapter, an IRB shall promptly notify in writing the investigator and the sponsor of the research when an IRB determines that it cannot approve the research because it does not meet the criteria in the exception provided under § 50.24(a) of this chapter or because of other relevant ethical concerns. The written notification shall include a statement of the reasons for the IRB's determination.
(f) An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.
(g) An IRB shall provide in writing to the sponsor of research involving an exception to informed consent under § 50.24 of this chapter a copy of information that has been publicly disclosed under § 50.24(a)(7)(ii) and (a)(7)(iii) of this chapter. The IRB shall provide this information to the sponsor promptly so that the sponsor is aware that such disclosure has occurred. Upon receipt, the sponsor shall provide copies of the information disclosed to FDA.
(h) When some or all of the subjects in a study are children, an IRB must determine that the research study is in compliance with part 50, subpart D of this chapter, at the time of its initial review of the research. When some or all of the subjects in a study that was ongoing on April 30, 2001, are children, an IRB must conduct a review of the research to determine compliance with part 50, subpart D of this chapter, either at the time of continuing review or, at the discretion of the IRB, at an earlier date.
[46 FR 8975, Jan. 27, 1981, as amended at 61 FR 51529, Oct. 2, 1996; 66 FR 20599, Apr. 24, 2001; 78 FR 12951, Feb. 26, 2013]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 56.109.
- 21 CFR 312.60General responsibilities of investigators3 letters cite both
- 21 CFR 50.27Documentation of informed consent3 letters cite both
- 21 CFR 56.115IRB records3 letters cite both
- 21 CFR 312.2Applicability2 letters cite both
- 21 CFR 312.20Requirement for an IND2 letters cite both
- 21 CFR 312.66Assurance of IRB review2 letters cite both
- 21 CFR 50.20General requirements for informed consent2 letters cite both
- 21 CFR 50.23Exception from general requirements2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 56.109 that FDA posted most recently.
- DrugsView Americo F. Padilla, M.D.Clinical investigations of investigational drugsIssuedMar 25, 2025PostedMar 25, 2025
- 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
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Counts include every citation in a letter, as the Letters filter does. How this database is built.