Document:USA 21 CFR Part 56 09-Apr-2025: Difference between revisions
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| 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 โFood and Drugs
Chapter I โFood and Drug Administration, Department of Health and Human Services Subchapter AโGeneral 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
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:USA 21 CFR Part 56 09-Apr-2025 ยง 56.110 (a) - (b) (1) | G | ยง 56.110
(a) - (b) (1) || EN || ยง 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. (a) The Food and Drug Administration has ... | ||
| Reference:USA 21 CFR Part 56 09-Apr-2025 ยง 56.104 (d) | G | ยง 56.104
(d) || EN || ยง 56.104 Exemptions from IRB requirement. The following categories of clinical investigations are exempt from the requirements of this part for IRB review: [...] (d) Taste and food quality ... | ||
| Reference:USA 21 CFR Part 56 09-Apr-2025 - | G | - | EN | Title 21 โFood and Drugs Chapter I โFood and Drug Administration, Department of Health and Human Services Subchapter AโGeneral Part 56 Institutional Review Boards https://www.ecfr.gov/current/title-21 |
| Reference:USA 21 CFR Part 56 09-Apr-2025 Subpart B | G | Subpart B | EN | Subpart BโOrganization and Personnel ยง 56.106 Registration [โฆ] ยง 56.107 IRB membership. [โฆ] |
| Reference:USA 21 CFR Part 56 09-Apr-2025 Subpart C | G | Subpart C | EN | Subpart CโIRB Functions and Operations ยง 56.108 IRB functions and operations. [โฆ] ยง 56.109 IRB review of research. [โฆ] (f) An IRB shall conduct continuing review of research covered by these ... |
| Reference:USA 21 CFR Part 56 09-Apr-2025 ยง 56.102 (m) | G | ยง 56.102
(m) || EN || ยง 56.102 Definitions. [...] (m) IRB approval means the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set ... | ||
| Reference:USA 21 CFR Part 56 09-Apr-2025 ยง 56.103 | G | ยง 56.103 | EN | ยง 56.103 Circumstances in which IRB review is required. (a) Except as provided in ยงยง 56.104 and 56.105, any clinical investigation which must meet the requirements for prior submission (as required ... |
| Reference:USA 21 CFR Part 56 09-Apr-2025 ยง 56.104 | G | ยง 56.104 | EN | ยง 56.104 Exemptions from IRB requirement. The following categories of clinical investigations are exempt from the requirements of this part for IRB review: (a) Any investigation which commenced ... |
| Reference:USA 21 CFR Part 56 09-Apr-2025 ยง 56.105 | G | ยง 56.105 | EN | ยง 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 requirements contained in these regulations, ... |
| Reference:USA 21 CFR Part 56 09-Apr-2025 ยง 56.109 | G | ยง 56.109 | EN | Subpart CโIRB Functions and Operations [..] ยง 56.109 IRB review of research. [โฆ] (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove ... |
| Reference:USA 21 CFR Part 56 09-Apr-2025 ยง 56.111 - ยง56.112 | G | ยง 56.111
- ยง56.112 || EN || ยง 56.111 Criteria for IRB approval of research. [โฆ] ยง 56.112 Review by institution. Research covered by these regulations that has been approved by an IRB may be subject to further appropriate review ... | ||
| Reference:USA 21 CFR Part 56 09-Apr-2025 ยง 56.110 (b) (2) | G | ยง 56.110
(b) (2) || EN || ยง 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. [โฆ] (b) An IRB may use the expedited review ... | ||
| Reference:USA 21 CFR Part 56 09-Apr-2025 ยง 56.113-001 | G | ยง 56.113 | EN | ยง 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 being conducted in accordance with the IRB's ... |
| Reference:USA 21 CFR Part 56 09-Apr-2025 ยง 56.113-002 | G | ยง 56.113 | EN | ยง 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 being conducted in accordance with the IRB's ... |
