45 CFR part 46 (Common Rule)
GPTKB entity
Statements (34)
| 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:appliesTo |
biomedical research
behavioral research federally funded research involving human subjects multi-site research studies research conducted or supported by federal departments and agencies |
| gptkbp:basisFor |
human subjects research ethics in the United States
|
| gptkbp:citation |
NIH research policy
university IRB policies |
| gptkbp:codifiedIn |
gptkb:Title_45,_Code_of_Federal_Regulations,_Part_46
|
| gptkbp:enforcedBy |
gptkb:Office_for_Human_Research_Protections
|
| gptkbp:excludes |
certain categories of low-risk research
|
| https://www.w3.org/2000/01/rdf-schema#label |
45 CFR part 46 (Common Rule)
|
| gptkbp:influencedBy |
gptkb:Belmont_Report
|
| gptkbp:referencedIn |
clinical trial protocols
federal grant applications |
| gptkbp:regulates |
protection of human subjects in research
|
| gptkbp:requires |
informed consent
Institutional Review Board approval documentation of consent continuing review of ongoing research protection of vulnerable populations reporting of unanticipated problems review of research protocols |
| gptkbp:revisedDate |
January 21, 2019
|
| gptkbp:section |
Subpart C (Additional Protections for Prisoners)
Subpart D (Additional Protections for Children) Subpart A (Basic HHS Policy for Protection of Human Research Subjects) Subpart B (Additional Protections for Pregnant Women, Human Fetuses and Neonates) |
| gptkbp:startDate |
January 13, 1981
|
| gptkbp:bfsParent |
gptkb:Office_for_Human_Research_Protections
|
| gptkbp:bfsLayer |
6
|