21 CFR 50.52
Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects
21 CFR 50.52 is the regulation titled “Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects” in 21 CFR Part 50, Protection of Human Subjects. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 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 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 12025
- 02026
What FDA writes when it cites it
The finding headings that cite 21 CFR 50.52 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 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 50.52 (eCFR, as of Sep 1, 2026)
Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, may involve children as subjects only if the IRB finds that:
(a) The risk is justified by the anticipated benefit to the subjects;
(b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and
(c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians as set forth in § 50.55.
[66 FR 20598, Apr. 24, 2001, as amended at 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 50.52.
- 21 CFR 312.60General responsibilities of investigators1 letter cites both
- 21 CFR 50.20General requirements for informed consent1 letter cites both
- 21 CFR 50.23Exception from general requirements1 letter cites both
- 21 CFR 50.24Exception from informed consent requirements for emergency research1 letter cites both
- 21 CFR 50.27Documentation of informed consent1 letter cites both
- 21 CFR 50.55Requirements for permission by parents or guardians and for assent by children1 letter cites both
- 21 CFR 56.109IRB review of research1 letter cites both
Latest letters citing it
The letter citing 21 CFR 50.52 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.