21 CFR 50.22
Exception from informed consent requirements for minimal risk clinical investigations
21 CFR 50.22 is the regulation titled “Exception from informed consent requirements for minimal risk clinical investigations” in 21 CFR Part 50, Protection of Human Subjects. Since 2021, 3 FDA warning letters have cited it.
- Letters citing it
- 3 since 2021
- Jan 1 to Oct 30, 2026
- 3 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 312.60, in 3 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.
- 02021
- 02022
- 02023
- 02024
- 02025
- 32026
What FDA writes when it cites it
The finding headings that cite 21 CFR 50.22 most often, as written in the letters.
- 3 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]
The regulation
Read the text of 21 CFR 50.22 (eCFR, as of Sep 1, 2026)
The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve an informed consent procedure that does not include or that alters some or all of the elements of informed consent set forth in § 50.25(a) and (b), or may waive the requirement to obtain informed consent, provided the IRB finds and documents the following:
(a) The clinical investigation involves no more than minimal risk to the subjects;
(b) The clinical investigation could not practicably be carried out without the requested waiver or alteration;
(c) If the clinical investigation involves using identifiable private information or identifiable biospecimens, the clinical investigation could not practicably be carried out without using such information or biospecimens in an identifiable format;
(d) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
(e) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
[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 50.22.
- 21 CFR 312.60General responsibilities of investigators3 letters cite both
- 21 CFR 320.31Applicability of requirements regarding an “Investigational New Drug Application.”3 letters cite both
- 21 CFR 50.20General requirements for informed consent3 letters cite both
- 21 CFR 312.3Definitions and interpretations1 letter cites both
- 21 CFR 312.341 letter cites both
- 21 CFR 50.25Elements of informed consent1 letter cites both
- 21 CFR 50.3Definitions1 letter cites both
- 21 CFR 50.331 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 50.22 that FDA posted most recently.
- DrugsView Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.investigational drug (b)(4)IssuedJul 10, 2026PostedJul 21, 2026
- DrugsView Sourav K. Mishra, M.D. / All India Institute of Medical Sciencesdoxorubicin hydrochloride liposome injection 20 mg/10 mLIssuedApr 29, 2026PostedMay 19, 2026
- DrugsView Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centredoxorubicin hydrochloride liposome injection 20 mg/10 mLIssuedApr 29, 2026PostedMay 12, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.