Document:USA 45 CFR Part 46 09-Apr-2025
From GxPlex
| Document information | |
|---|---|
| Reference | USA 45 CFR Part 46 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 45 CFR Part 46 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 45—Public Welfare
Subtitle A—Department of Health and Human Services Subchapter A—General Administration Part 46 Protection of Human Subjects https://www.ecfr.gov/current/title-45 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| USA 45 CFR Part 46 09-Apr-2025 Subpart B | G | Subpart B | EN | Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
[…] § 46.203 Duties of IRBs in connection with re… |
| USA 45 CFR Part 46 09-Apr-2025 Subpart C | G | Subpart C | EN | Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
[…] § 46.303 Definitions. […] (c) Pr… |
| USA 45 CFR Part 46 09-Apr-2025 Subpart D | G | Subpart D | EN | Subpart D—Additional Protections for Children Involved as Subjects in Research
[…] § 46.402 Definitions. The definitions in § 46.102 of the pre-2018 R… |
| USA 45 CFR Part 46 09-Apr-2025 Subpart E | G | Subpart E | EN | Subpart E—Registration of Institutional Review Boards
[…] § 46.501 What IRBs must be registered? Each IRB that is designated by an institution under a… |
| USA 45 CFR Part 46 09-Apr-2025 § 46.102 (b) | G | § 46.102 (b) | EN | (b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may inclu… |
| USA 45 CFR Part 46 09-Apr-2025 § 46.102 (e) (1) | G | § 46.102 (e) (1) | EN | (e)
(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains informat… |
| USA 45 CFR Part 46 09-Apr-2025 § 46.102 (m) | G | § 46.102 (m) | EN | (m) Written, or in writing, for purposes of this part, refers to writing on a tangible medium (e.g., paper) or in an electronic format.… |
| USA 45 CFR Part 46 09-Apr-2025 § 46.104 | G | § 46.104 | EN | § 46.104 Exempt research. […]… |
| USA 45 CFR Part 46 09-Apr-2025 § 46.107 - § 46.112 | G | § 46.107 - § 46.112 | EN | § 46.107 IRB membership.
[…] § 46.108 IRB functions and operations. […] § 46.109 IRB review of research. […] § 46.110 Expedited review procedures for … |
| USA 45 CFR Part 46 09-Apr-2025 § 46.113 | G | § 46.113 | EN | § 46.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not b… |
| USA 45 CFR Part 46 09-Apr-2025 § 46.115 | G | § 46.115 | EN | § 46.115 IRB records. […]… |
| USA 45 CFR Part 46 09-Apr-2025 § 46.116 | G | § 46.116 | EN | § 46.116 General requirements for informed consent.
(a) General. General requirements for informed consent, whether written or oral, […] (b) Basic el… |
| USA 45 CFR Part 46 09-Apr-2025 § 46.117 | G | § 46.117 | EN | § 46.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use … |
| USA 45 CFR Part 46 09-Apr-2025 § 46.123 | G | § 46.123 | EN | § 46.123 Early termination of research support: Evaluation of applications and proposals. (a) The department or agency head may require that Federal d… |
| USA 45 CFR Part 46 09-Apr-2025 § 46.124 | G | § 46.124 | EN | § 46.124 Conditions. With respect to any research project or any class of research projects the department or agency head of either the conducting or … |
