Statements (50)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:Ethics
|
| gptkbp:abbreviation |
gptkb:IRB
|
| gptkbp:approvedBy |
Research involving human subjects
|
| gptkbp:canBe |
Disapprove research protocols
Require modifications to research protocols Suspend research Terminate research |
| gptkbp:establishedBy |
Research institutions
|
| gptkbp:existsIn |
Government agencies
Universities Hospitals Private research organizations |
| https://www.w3.org/2000/01/rdf-schema#label |
Institutional Review Boards
|
| gptkbp:must_include |
Scientists
Community members Diverse backgrounds Non-scientists |
| gptkbp:originatedIn |
gptkb:United_States
|
| gptkbp:oversees |
Informed consent process
|
| gptkbp:purpose |
Protect rights and welfare of human research subjects
|
| gptkbp:regulates |
Human subjects research
|
| gptkbp:relatedTo |
gptkb:Food_and_Drug_Administration
gptkb:Belmont_Report gptkb:Office_for_Human_Research_Protections gptkb:Declaration_of_Helsinki gptkb:Nuremberg_Code Human subject protection Research ethics |
| gptkbp:requires |
gptkb:United_States_federal_law
gptkb:Common_Rule FDA regulations Conduct continuing review FDA-regulated research Federally funded research Maintain records Report serious or continuing noncompliance Report unanticipated problems |
| gptkbp:reviewedBy |
Data confidentiality
Privacy protections Research protocols Risk-benefit analysis Vulnerable populations protections |
| gptkbp:sometimesCalled |
gptkb:Human_research_ethics_committee
Ethics review board Independent ethics committee Research ethics committee |
| gptkbp:subject |
gptkb:21_CFR_56
gptkb:45_CFR_46 |
| gptkbp:bfsParent |
gptkb:Office_of_Human_Research_Protections
|
| gptkbp:bfsLayer |
5
|