Reference:USA 21 CFR Part 50 09-Apr-2025 Subpart D
From GxPlex
| 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 | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.1.4 |
| Scope | G |
| Document part | Subpart D |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Minor / Paediatric, Assent, Legal representative, Ethics committee, Risk classification |
Content
Subpart D—Additional Safeguards for Children in Clinical Investigations […] § 50.50 IRB duties. […] § 50.51 Clinical investigations not involving greater than minimal risk. […] § 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects. [...] § 50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition. [...] § 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. [....] § 50.55 Requirements for permission by parents or guardians and for assent by children. [...] § 50.56 Wards. [...]
