Document:USA 21 CFR Part 56 09-Apr-2025: Difference between revisions
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Latest revision as of 14:15, 16 July 2026
| Document information | |
|---|---|
| Reference | USA 21 CFR Part 56 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 21 CFR Part 56 |
| 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 56 Institutional Review Boards https://www.ecfr.gov/current/title-21 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| USA 21 CFR Part 56 09-Apr-2025 - | G | - | EN | Title 21 —Food and Drugs
Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 56 Institutional R… |
| USA 21 CFR Part 56 09-Apr-2025 Subpart B | G | Subpart B | EN | Subpart B—Organization and Personnel
§ 56.106 Registration […] § 56.107 IRB membership. […]… |
| USA 21 CFR Part 56 09-Apr-2025 Subpart C | G | Subpart C | EN | Subpart C—IRB Functions and Operations
§ 56.108 IRB functions and operations. […] § 56.109 IRB review of research. […] (f) An IRB shall conduct contin… |
| USA 21 CFR Part 56 09-Apr-2025 § 56.102 (m) | G | § 56.102 (m) | EN | § 56.102 Definitions.
[...] (m) IRB approval means the determination of the IRB that the clinical investigation has been reviewed and may be conducted… |
| USA 21 CFR Part 56 09-Apr-2025 § 56.103 | G | § 56.103 | EN | § 56.103 Circumstances in which IRB review is required. (a) Except as provided in §§ 56.104 and 56.105, any clinical investigation which must meet the… |
| USA 21 CFR Part 56 09-Apr-2025 § 56.104 | G | § 56.104 | EN | § 56.104 Exemptions from IRB requirement. The following categories of clinical investigations are exempt from the requirements of this part for IRB re… |
| USA 21 CFR Part 56 09-Apr-2025 § 56.104 (d) | G | § 56.104 (d) | EN | § 56.104 Exemptions from IRB requirement. The following categories of clinical investigations are exempt from the requirements of this part for IRB re… |
| USA 21 CFR Part 56 09-Apr-2025 § 56.105 | G | § 56.105 | EN | § 56.105 Waiver of IRB requirement. On the application of a sponsor or sponsor-investigator, the Food and Drug Administration may waive any of the req… |
| USA 21 CFR Part 56 09-Apr-2025 § 56.109 | G | § 56.109 | EN | Subpart C—IRB Functions and Operations
[..] § 56.109 IRB review of research. […] (a) An IRB shall review and have authority to approve, require modifi… |
| USA 21 CFR Part 56 09-Apr-2025 § 56.110 (a) - (b) (1) | G | § 56.110 (a) - (b) (1) | EN | § 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. (a… |
| USA 21 CFR Part 56 09-Apr-2025 § 56.110 (b) (2) | G | § 56.110 (b) (2) | EN | § 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. […… |
| USA 21 CFR Part 56 09-Apr-2025 § 56.111 - §56.112 | G | § 56.111
- §56.112 | EN | § 56.111 Criteria for IRB approval of research.
[…] § 56.112 Review by institution. Research covered by these regulations that has been approved by an… |
| USA 21 CFR Part 56 09-Apr-2025 § 56.113-001 | G | § 56.113 | EN | § 56.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not b… |
| USA 21 CFR Part 56 09-Apr-2025 § 56.113-002 | G | § 56.113 | EN | § 56.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not b… |
