Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:administeredBy |
gptkb:U.S._Department_of_Health_and_Human_Services
|
| gptkbp:alsoKnownAs |
gptkb:Common_Rule
|
| gptkbp:amendedBy |
gptkb:2017_Final_Rule_(Revised_Common_Rule)
|
| gptkbp:appliesTo |
research involving human subjects conducted or supported by federal departments or agencies
|
| gptkbp:basisFor |
human subjects research regulations in the United States
|
| gptkbp:codifiedIn |
45 CFR 46.101-46.124
|
| gptkbp:establishes |
requirements for IRB functions and operations
requirements for IRB membership criteria for IRB approval of research requirements for general assurances of compliance requirements for informed consent documentation |
| gptkbp:excludes |
certain categories of research from IRB review
|
| https://www.w3.org/2000/01/rdf-schema#label |
45 CFR 46, Subpart A
|
| gptkbp:partOf |
gptkb:45_CFR_46
|
| gptkbp:referencedIn |
federal agencies and research institutions
|
| gptkbp:regulates |
protection of human subjects in research
|
| gptkbp:requires |
gptkb:Institutional_Review_Board_(IRB)_review
informed consent additional protections for vulnerable populations |
| gptkbp:startDate |
January 21, 2019
|
| gptkbp:bfsParent |
gptkb:Common_Rule
|
| gptkbp:bfsLayer |
6
|