Document:USA 21 CFR Part 50 09-Apr-2025
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| 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
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| 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 grea… |
| 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 su… |
| 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 conti… |
| 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 (ex… |
| USA 21 CFR Part 50 09-Apr-2025 § 50.24 | G | § 50.24 | EN | § 50.24 Exception from informed consent requirements for emergency research. […]… |
| 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. […]… |
| 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 me… |
| 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… |
| 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 … |
| 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… |
| 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 adminis… |
| 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 admi… |
| 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 who… |
| 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 subjec… |
| 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(… |
| 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 in… |
| 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, ele… |
| 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 … |
| 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 … |
| 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 prospect… |
| 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,… |
| 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 agr… |
| 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 … |
| 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.… |
| 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, St… |
| 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.… |
| 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.… |
| 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 followi… |
