Statements (51)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:Ethics
|
| gptkbp:abbreviation |
gptkb:IRB
|
| gptkbp:approvedBy |
research involving human participants
|
| gptkbp:can_disapprove |
research protocols
|
| gptkbp:can_suspend |
ongoing research
|
| gptkbp:can_terminate |
ongoing research
|
| gptkbp:documentation |
meeting minutes
approval letters correspondence with investigators written policies and procedures |
| gptkbp:establishedBy |
research institutions
|
| https://www.w3.org/2000/01/rdf-schema#label |
Institutional Review Board
|
| gptkbp:meetingPlace |
regularly
|
| gptkbp:membersInclude |
gptkb:scientist
community members nonscientists |
| gptkbp:must_include |
at least one nonscientist
at least one member unaffiliated with the institution |
| gptkbp:oversees |
clinical trials
|
| gptkbp:prohibits |
all members of one gender
members with conflicts of interest reviewing their own research |
| gptkbp:purpose |
protect rights and welfare of human research subjects
|
| gptkbp:regulates |
human subjects research
|
| gptkbp:relatedTo |
gptkb:Common_Rule
gptkb:Belmont_Report gptkb:Ethics_Committee_(Europe) gptkb:Human_Research_Ethics_Committee_(Australia) gptkb:Research_Ethics_Board_(Canada) informed consent |
| gptkbp:requires |
gptkb:United_States_federal_law
gptkb:U.S._Department_of_Health_and_Human_Services gptkb:U.S._Food_and_Drug_Administration at least five members modifications to research protocols |
| gptkbp:reviewedBy |
adverse event reports
continuing review applications protocol amendments research protocols recruitment materials data safety monitoring plans exempt research expedited review research informed consent documents minimal risk research privacy and confidentiality protections vulnerable populations research |
| gptkbp:subject |
federal regulations
federal audits institutional oversight |
| gptkbp:bfsParent |
gptkb:IRB
|
| gptkbp:bfsLayer |
5
|