2017 Final Rule (Revised Common Rule)
GPTKB entity
Statements (34)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:alsoKnownAs |
Revised Common Rule
|
| gptkbp:appliesTo |
federally funded research
U.S. institutions conducting human subjects research |
| gptkbp:clarity |
definition of human subject
definition of research exempt research categories |
| gptkbp:codifiedIn |
gptkb:45_CFR_46,_Subpart_A
|
| gptkbp:compatibleWith |
FDA-regulated research
Department of Justice research |
| gptkbp:containsProvision |
broad consent
continuing review changes exempt research categories limited IRB review new informed consent requirements single IRB review requirement |
| gptkbp:governs |
informed consent process
IRB operations participant protections researcher responsibilities |
| https://www.w3.org/2000/01/rdf-schema#label |
2017 Final Rule (Revised Common Rule)
|
| gptkbp:intendedUse |
reduce administrative burden
enhance protections for research participants modernize human subjects research regulations |
| gptkbp:mandate |
posting of consent forms for certain clinical trials
use of single IRB for multi-site studies |
| gptkbp:publicationDate |
January 19, 2017
|
| gptkbp:publishedBy |
gptkb:U.S._Department_of_Health_and_Human_Services
|
| gptkbp:publishedIn |
gptkb:Federal_Register
|
| gptkbp:regulates |
human subjects research
|
| gptkbp:replacedBy |
1991 Common Rule
|
| gptkbp:startDate |
January 21, 2019
|
| gptkbp:bfsParent |
gptkb:45_CFR_46,_Subpart_A
|
| gptkbp:bfsLayer |
7
|