|
gptkbp:instanceOf
|
gptkb:legislation
gptkb:public_policy
|
|
gptkbp:adoptedBy
|
multiple U.S. federal agencies
|
|
gptkbp:alsoKnownAs
|
gptkb:Federal_Policy_for_the_Protection_of_Human_Subjects
|
|
gptkbp:appliesTo
|
biomedical research
hospitals
universities
research institutions
behavioral research
federally funded research
|
|
gptkbp:basisFor
|
U.S. research ethics standards
|
|
gptkbp:codifiedIn
|
gptkb:45_CFR_46,_Subpart_A
|
|
gptkbp:enforcedBy
|
gptkb:U.S._Department_of_Health_and_Human_Services
gptkb:Office_for_Human_Research_Protections
|
|
gptkbp:excludes
|
certain low-risk research
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
U.S. Common Rule
|
|
gptkbp:originallyAdopted
|
1991
|
|
gptkbp:purpose
|
protect rights and welfare of human research subjects
|
|
gptkbp:regulates
|
human subjects research
|
|
gptkbp:requires
|
informed consent
Institutional Review Board approval
additional protections for vulnerable populations
documentation of consent
continuing review of research
|
|
gptkbp:startDate
|
January 21, 2019
|
|
gptkbp:updated
|
2017 Final Rule
|
|
gptkbp:bfsParent
|
gptkb:Nuremberg_Code
|
|
gptkbp:bfsLayer
|
6
|