21 CFR 50.27
Documentation of informed consent
21 CFR 50.27 is the regulation titled “Documentation of informed consent” in 21 CFR Part 50, Protection of Human Subjects. Since 2021, 5 FDA warning letters have cited it.
- Letters citing it
- 5 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 312.2, in 3 letters
- Closed out
- 0% 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 50.27 most often, as written in the letters.
- 1 letterYou failed to adhere to these requirements. Protocol **(b)(4)** was a clinical trial involving children and adolescents, ages ≥6 to <18 years. The IRB determined that Protocol **(b)(4)** was a research study that meets…
- 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)]
The regulation
Read the text of 21 CFR 50.27 (eCFR, as of Sep 1, 2026)
(a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy shall be given to the person signing the form.
(b) Except as provided in § 56.109(c), the consent form may be either of the following:
(1) A written consent document that embodies the elements of informed consent required by § 50.25. This form may be read to the subject or the subject's legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed.
(2) A short form written consent document stating that the elements of informed consent required by § 50.25 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.
[46 FR 8951, Jan. 27, 1981, as amended at 61 FR 57280, Nov. 5, 1996]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 50.27.
- 21 CFR 312.2Applicability3 letters cite both
- 21 CFR 312.20Requirement for an IND3 letters cite both
- 21 CFR 312.60General responsibilities of investigators3 letters cite both
- 21 CFR 50.20General requirements for informed consent3 letters cite both
- 21 CFR 56.109IRB review of research3 letters cite both
- 21 CFR 50.23Exception from general requirements2 letters cite both
- 21 CFR 50.24Exception from informed consent requirements for emergency research2 letters cite both
- 21 CFR 50.55Requirements for permission by parents or guardians and for assent by children2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 50.27 that FDA posted most recently.
- BiologicsView Stephen J. Fallon, Ph.D.INSTI® HIV Self-TestIssuedAug 27, 2026PostedSep 8, 2026
- DrugsView Americo F. Padilla, M.D.Clinical investigations of investigational drugsIssuedMar 25, 2025PostedMar 25, 2025
- DrugsView Maggie Jeffries, M.D. / Avanti Anesthesiology, LLCClinical investigations of investigational drugs for anesthesiaIssuedMar 3, 2023PostedMar 14, 2023
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Counts include every citation in a letter, as the Letters filter does. How this database is built.