Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.22
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 3.1.1 |
| Scope | G |
| Document part | § 50.22 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Informed consent, Risk classification, Ethics committee, Clinical investigation, FDA |
| Comment | Exception from consent requirements for minimal-risk investigations |
Content
§ 50.22 Exception from informed consent requirements for minimal risk clinical investigations. The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve an informed consent procedure that does not include or that alters some or all of the elements of informed consent set forth in § 50.25(a) and (b), or may waive the requirement to obtain informed consent, provided the IRB finds and documents the following: (a) The clinical investigation involves no more than minimal risk to the subjects; (b) The clinical investigation could not practicably be carried out without the requested waiver or alteration; (c) If the clinical investigation involves using identifiable private information or identifiable biospecimens, the clinical investigation could not practicably be carried out without using such information or biospecimens in an identifiable format; (d) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and (e) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
