21 CFR 50.55
Requirements for permission by parents or guardians and for assent by children
21 CFR 50.55 is the regulation titled “Requirements for permission by parents or guardians and for assent by children” in 21 CFR Part 50, Protection of Human Subjects. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 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 2 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.
What FDA writes when it cites it
The finding headings that cite 21 CFR 50.55 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; 21 CFR 50.20; 21 CFR 50.27; 21 CFR 50.52; 21 CFR 50.55]
The regulation
Read the text of 21 CFR 50.55 (eCFR, as of Sep 1, 2026)
(a) In addition to the determinations required under other applicable sections of this subpart D, the IRB must determine that adequate provisions are made for soliciting the assent of the children when in the judgment of the IRB the children are capable of providing assent.
(b) In determining whether children are capable of providing assent, the IRB must take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in clinical investigations under a particular protocol, or for each child, as the IRB deems appropriate.
(c) The assent of the children is not a necessary condition for proceeding with the clinical investigation if the IRB determines:
(1) That the capability of some or all of the children is so limited that they cannot reasonably be consulted, or
(2) That the intervention or procedure involved in the clinical investigation holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the clinical investigation.
(d) Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement if it finds and documents that:
(1) The clinical investigation involves no more than minimal risk to the subjects;
(2) The waiver will not adversely affect the rights and welfare of the subjects;
(3) The clinical investigation could not practicably be carried out without the waiver; and
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
(e) In addition to the determinations required under other applicable sections of this subpart D, the IRB must determine, in accordance with and to the extent that consent is required under part 50, that the permission of each child's parents or guardian is granted.
(1) Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for clinical investigations to be conducted under § 50.51 or § 50.52.
(2) Where clinical investigations are covered by § 50.53 or § 50.54 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
(f) Permission by parents or guardians must be documented in accordance with and to the extent required by § 50.27.
(g) When the IRB determines that assent is required, it must also determine whether and how assent must be documented.
[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 50.55.
- 21 CFR 312.60General responsibilities of investigators2 letters cite both
- 21 CFR 50.20General requirements for informed consent2 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 50.27Documentation of informed consent2 letters cite both
- 21 CFR 56.109IRB review of research2 letters cite both
- 21 CFR 312.2Applicability1 letter cites both
- 21 CFR 312.20Requirement for an IND1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 50.55 that FDA posted most recently.
- DrugsView Americo F. Padilla, M.D.Clinical investigations of investigational drugsIssuedMar 25, 2025PostedMar 25, 2025
- DrugsView Daniel Fred Goodman, M.D./Goodman Eye CenterClinical investigation of investigational drug (b)(4) under Protocol (b)(4)IssuedJul 14, 2022PostedJul 26, 2022
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Counts include every citation in a letter, as the Letters filter does. How this database is built.