Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (e) (1)
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| 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 3.1.1 |
| Scope | G |
| Document part | § 46.102
(e) (1) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Trial participant, Definition, Biological sample |
Content
(e) (1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
