21 CFR 50.20
General requirements for informed consent
21 CFR 50.20 is the regulation titled “General requirements for informed consent” in 21 CFR Part 50, Protection of Human Subjects. Since 2021, 13 FDA warning letters have cited it.
- Letters citing it
- 13 since 2021
- Jan 1 to Oct 30, 2026
- 6 against 3 on the same dates in 2025
- Most often cited with
- 21 CFR 312.60, in 12 letters
- Closed out
- 8% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (10 of 13). 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 50.20 most often, as written in the letters.
- 8 lettersYou failed to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR 50.20]
- 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; 21 CFR 50.20; 21 CFR 50.27; 21 CFR 50.52; 21 CFR 50.55]
The regulation
Read the text of 21 CFR 50.20 (eCFR, as of Sep 1, 2026)
Except as provided in §§ 50.22, 50.23, and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
[46 FR 8951, Jan. 27, 1981, as amended at 64 FR 10942, Mar. 8, 1999; 88 FR 88248, Dec. 21, 2023]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 50.20.
- 21 CFR 312.60General responsibilities of investigators12 letters cite both
- 21 CFR 50.23Exception from general requirements8 letters cite both
- 21 CFR 50.24Exception from informed consent requirements for emergency research7 letters cite both
- 21 CFR 312.62Investigator recordkeeping and record retention3 letters cite both
- 21 CFR 320.31Applicability of requirements regarding an “Investigational New Drug Application.”3 letters cite both
- 21 CFR 50.22Exception from informed consent requirements for minimal risk clinical investigations3 letters cite both
- 21 CFR 50.27Documentation of informed consent3 letters cite both
- 21 CFR 312.2Applicability2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 50.20 that FDA posted most recently.
- BiologicsView Stephen J. Fallon, Ph.D.INSTI® HIV Self-TestIssuedAug 27, 2026PostedSep 8, 2026
- DrugsView Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.investigational drug (b)(4)IssuedJul 10, 2026PostedJul 21, 2026
- BiologicsView Adnan Dahdul, MDYou failed to obtain legally effective informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR…IssuedMar 12, 2026PostedMay 26, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.