Institutional Review Board (USA)
GPTKB entity
Statements (49)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:government_agency
|
| gptkbp:alsoKnownAs |
gptkb:IRB
|
| gptkbp:approvedBy |
research involving human subjects
|
| gptkbp:awardedBy |
exempt status
expedited review waivers of consent |
| gptkbp:canDisapprove |
research protocols
|
| gptkbp:canSuspend |
research approval
|
| gptkbp:canTerminate |
research approval
|
| gptkbp:country |
gptkb:United_States
|
| gptkbp:established |
1974
|
| gptkbp:establishedBy |
research institutions
|
| gptkbp:governedBy |
Food and Drug Administration regulations
Department of Health and Human Services regulations |
| https://www.w3.org/2000/01/rdf-schema#label |
Institutional Review Board (USA)
|
| gptkbp:legalBasis |
gptkb:21_CFR_56
gptkb:45_CFR_46 |
| gptkbp:maintainedBy |
records of reviews
|
| gptkbp:meetingPlace |
regularly
|
| gptkbp:membersInclude |
gptkb:scientist
community members nonscientists |
| gptkbp:mustAvoid |
conflicts of interest
|
| gptkbp:numberOfMembers |
5
|
| gptkbp:originatedIn |
gptkb:National_Research_Act
|
| gptkbp:oversees |
gptkb:Office_for_Human_Research_Protections
FDA (for drug/device studies) |
| gptkbp:purpose |
protect rights and welfare of research participants
|
| gptkbp:regulates |
human subjects research
|
| gptkbp:relatedTo |
gptkb:Common_Rule
gptkb:Belmont_Report ethics in research |
| gptkbp:reportsTo |
serious or continuing noncompliance
suspensions or terminations of approval unanticipated problems |
| gptkbp:requires |
gptkb:United_States_federal_law
federally funded research modifications to research protocols FDA-regulated research both genders at least one member unaffiliated with institution |
| gptkbp:responsibleFor |
animal research
|
| gptkbp:reviewedBy |
privacy protections
research protocols informed consent documents vulnerable populations research risk/benefit analysis |
| gptkbp:bfsParent |
gptkb:Human_research_ethics_committee
|
| gptkbp:bfsLayer |
7
|