Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart C
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 | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.1.4 |
| Scope | G |
| Document part | Subpart C |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Vulnerable participants, Definition, Ethics committee, Trial participant |
Content
Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects […] § 46.303 Definitions. […] (c) Prisoner means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. [...] § 46.304 Composition of Institutional Review Boards where prisoners are involved. [...] § 46.305 Additional duties of the Institutional Review Boards where prisoners are involved. [...] § 46.306 Permitted research involving prisoners. [...]
