21 CFR 50.25
Elements of informed consent
21 CFR 50.25 is the regulation titled “Elements of informed consent” in 21 CFR Part 50, Protection of Human Subjects. Since 2021, 4 FDA warning letters have cited it.
- Letters citing it
- 4 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 50.20, in 2 letters
- Closed out
- 25% of these letters have a published close-out
Letters citing it, by year issued
Most are biologics letters (2 of 4). 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 50.25 most often, as written in the letters.
- 1 letterFailure to ensure that information given to subjects as part of informed consent is in accordance with 21 CFR 50.25 [21 CFR § 56.109(b)]
The regulation
Read the text of 21 CFR 50.25 (eCFR, as of Sep 1, 2026)
(a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject:
(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
(2) A description of any reasonably foreseeable risks or discomforts to the subject.
(3) A description of any benefits to the subject or to others which may reasonably be expected from the research.
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.
(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
(8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
(b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
(3) Any additional costs to the subject that may result from participation in the research.
(4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
(5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
(6) The approximate number of subjects involved in the study.
(c) When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be provided to each clinical trial subject in informed consent documents and processes. This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act. The statement is: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
(d) The informed consent requirements in these regulations are not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed for informed consent to be legally effective.
(e) Nothing in these regulations is intended to limit the authority of a physician to provide emergency medical care to the extent the physician is permitted to do so under applicable Federal, State, or local law.
[46 FR 8951, Jan. 27, 1981, as amended at 76 FR 270, Jan. 4, 2011]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 50.25.
- 21 CFR 50.20General requirements for informed consent2 letters cite both
- 21 CFR 56.109IRB review of research2 letters cite both
- 21 CFR 56.115IRB records2 letters cite both
- 21 CFR 312.3Definitions and interpretations1 letter cites both
- 21 CFR 312.341 letter cites both
- 21 CFR 312.60General responsibilities of investigators1 letter cites both
- 21 CFR 320.31Applicability of requirements regarding an “Investigational New Drug Application.”1 letter cites both
- 21 CFR 50.22Exception from informed consent requirements for minimal risk clinical investigations1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 50.25 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 Massachusetts Institute of Technology MITIRB oversight of clinical investigationsIssuedJun 21, 2024PostedJul 16, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.