Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.116
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 3.1.1 |
| Scope | G |
| Document part | § 46.116 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Informed consent, Consent form, Requirements, Biological sample |
| Comment | General requirements for informed consent (HHS) |
Content
§ 46.116 General requirements for informed consent. (a) General. General requirements for informed consent, whether written or oral, […] (b) Basic elements of informed consent […] (c) Additional elements of informed consent […] (d) Elements of broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens [...] (e) Waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials — [...] (f) General waiver or alteration of consent — [...] (g) Screening, recruiting, or determining eligibility [...] (i) Preemption [...] (j) Emergency medical care. [...]
