Institutional Review Board (IRB) review
GPTKB entity
Statements (50)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
research ethics process
|
| gptkbp:appliesTo |
gptkb:philosophy
biomedical research behavioral research |
| gptkbp:cause |
approval
disapproval modification request |
| gptkbp:conductedBy |
gptkb:Institutional_Review_Board
|
| gptkbp:guarantees |
gptkb:legislation
informed consent process ethical standards benefit-risk assessment risk minimization data safety monitoring equitable subject selection |
| https://www.w3.org/2000/01/rdf-schema#label |
Institutional Review Board (IRB) review
|
| gptkbp:mandate |
gptkb:U.S._federal_regulations
|
| gptkbp:mayInclude |
expedited review
exempt review full board review |
| gptkbp:monitors |
ongoing research
|
| gptkbp:originatedIn |
gptkb:Belmont_Report
|
| gptkbp:protectedBy |
vulnerable populations
privacy and confidentiality |
| gptkbp:purpose |
protect rights and welfare of research participants
|
| gptkbp:relatedTo |
gptkb:Ethics
gptkb:45_CFR_46 gptkb:Common_Rule human subjects protection participant protection research oversight |
| gptkbp:requires |
gptkb:Food_and_Drug_Administration_(FDA)
gptkb:U.S._Department_of_Health_and_Human_Services gptkb:National_Institutes_of_Health_(NIH) clinical trials hospitals universities research institutions federally funded research human subjects research industry-sponsored research international research guidelines research initiation student research involving humans |
| gptkbp:reviewedBy |
adverse event reports
protocol amendments research protocols informed consent documents |
| gptkbp:bfsParent |
gptkb:45_CFR_46,_Subpart_A
|
| gptkbp:bfsLayer |
7
|