Statements (29)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
gptkb:public_policy |
| gptkbp:administeredBy |
gptkb:Office_for_Human_Research_Protections
|
| gptkbp:adoptedBy |
multiple U.S. federal agencies
|
| gptkbp:appliesTo |
federally funded research
research involving human subjects universities and research institutions receiving federal funding |
| gptkbp:basisFor |
human subjects research ethics
|
| gptkbp:codifiedIn |
gptkb:45_CFR_46,_Subpart_A
|
| gptkbp:enactedBy |
gptkb:United_States_federal_government
|
| gptkbp:excludes |
certain categories of low-risk research
|
| gptkbp:fullName |
gptkb:Federal_Policy_for_the_Protection_of_Human_Subjects
|
| https://www.w3.org/2000/01/rdf-schema#label |
The Common Rule
|
| gptkbp:includes |
requirements for IRB membership
requirements for informed consent documentation requirements for research records retention |
| gptkbp:influencedBy |
gptkb:Belmont_Report
|
| gptkbp:originalEffectiveDate |
January 19, 1981
|
| gptkbp:purpose |
protect rights and welfare of human research subjects
|
| gptkbp:relatedTo |
gptkb:HIPAA_Privacy_Rule
Food and Drug Administration regulations |
| gptkbp:requires |
informed consent
Institutional Review Board approval continuing review of ongoing research reporting of unanticipated problems and adverse events |
| gptkbp:startDate |
January 19, 2017
|
| gptkbp:updated |
2017
|
| gptkbp:bfsParent |
gptkb:45_CFR_46
|
| gptkbp:bfsLayer |
6
|