Document:USA 21 CFR Part 50 09-Apr-2025

Document information
Reference	USA 21 CFR Part 50 09-Apr-2025
Validity area	USA
Scope(s)	G
Document name	21 CFR Part 50
Version / Revision	09-Apr-2025
Status	Current
Document type	Legal act
Language(s)	EN
Description	Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 50 Protection of Human Subjects https://www.ecfr.gov/current/title-21
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

References

Reference	Scope	Document part	Language	Preview
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (c)	G	§ 50.3 (c) || EN || (c) Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3	G	§ 50.3	EN	§ 50.3 Definitions. As used in this part: (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq. as amended (21 U.S.C. 321-392)). (b) Application for ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (k)-001	G	§ 50.3 (k) || EN || (k) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (i)	G	§ 50.3 (i) || EN || (i) Institutional review board (IRB) means any board, committee, or other group formally designated by an institution to review biomedical research involving humans as subjects, to approve the ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (e)	G	§ 50.3 (e) || EN || (e) Sponsor means a person who initiates a clinical investigation, but who does not actually conduct the investigation, i.e., the test article is administered or dispensed to or used involving, a ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (f)	G	§ 50.3 (f) || EN || (f) Sponsor-investigator means an individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (d)	G	§ 50.3 (d) || EN || (d) Investigator means an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (h)	G	§ 50.3 (h) || EN || (h) Institution means any public or private entity or agency (including Federal, State, and other agencies). The word facility as used in section 520(g) of the act is deemed to be synonymous with the ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.25 (e)	G	§ 50.25 (e) || EN || § 50.25 Elements of informed consent. [...] (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 ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (g)	G	§ 50.3 (g) || EN || (g) Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (k)-002	G	§ 50.3 (k) || EN || (k) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (l)	G	§ 50.3 (l) || EN || (l) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's particpation in the ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.20	G	§ 50.20	EN	§ 50.20 General requirements for informed consent. 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 ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.22	G	§ 50.22	EN	§ 50.22 Exception from informed consent requirements for minimal risk clinical investigations. The IRB responsible for the review, approval, and continuing review of the clinical investigation ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.23	G	§ 50.23	EN	§ 50.23 Exception from general requirements. (a) The obtaining of informed consent shall be deemed feasible unless, before use of the test article (except as provided in paragraph (b) of this ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.24	G	§ 50.24	EN	§ 50.24 Exception from informed consent requirements for emergency research. […]
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.25 (a) - (b)	G	§ 50.25 (a) - (b) || EN || § 50.25 Elements of informed consent. (a) Basic elements of informed consent […] (b) Additional elements of informed consent. […]
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.27	G	§ 50.27	EN	§ 50.27 Documentation of informed consent. (a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (m)	G	§ 50.3 (m) || EN || (m) Family member means any one of the following legally competent persons: Spouse; parents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (n)	G	§ 50.3 (n) || EN || (n) Assent means a child's affirmative agreement to participate in a clinical investigation. Mere failure to object should not, absent affirmative agreement, be construed as assent.
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (o)	G	§ 50.3 (o) || EN || (o) Children means persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (p)	G	§ 50.3 (p) || EN || (p) Parent means a child's biological or adoptive parent.
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (q)	G	§ 50.3 (q) || EN || (q) Ward means a child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State, or local law.
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (r)	G	§ 50.3 (r) || EN || (r) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in a clinical investigation.
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (s)	G	§ 50.3 (s) || EN || (s) Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.
Reference:USA 21 CFR Part 50 09-Apr-2025 Subpart D	G	Subpart D	EN	Subpart D—Additional Safeguards for Children in Clinical Investigations […] § 50.50 IRB duties. […] § 50.51 Clinical investigations not involving greater than minimal risk. […] § 50.52 Clinical ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 812.36 (c)	G	§ 812.36 (c) || EN || § 812.36 Treatment use of an investigational device. (c) Applications for treatment use. (1) A treatment IDE application shall include, in the following order: [...] (ii) The intended use of the ...
Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (j)	G	§ 50.3 (j) || EN || (j) Test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to ...