AI-created image
Statements (47)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:Ethics
|
| gptkbp:alsoKnownAs |
gptkb:IRB
|
| gptkbp:approvedBy |
research protocols
|
| gptkbp:authority |
suspend research
terminate research |
| gptkbp:canDisapprove |
research protocols
|
| gptkbp:canWaive |
informed consent in limited circumstances
|
| gptkbp:compatibleWith |
conflict of interest in reviewed research
|
| gptkbp:establishedBy |
gptkb:National_Research_Act_of_1974
|
| gptkbp:function |
review research involving human subjects
|
| https://www.w3.org/2000/01/rdf-schema#label |
institutional review boards
|
| gptkbp:maintainedBy |
records for at least three years
|
| gptkbp:mayConsult |
outside experts
|
| gptkbp:meetingPlace |
regularly
|
| gptkbp:membersInclude |
gptkb:scientist
community members nonscientists |
| gptkbp:mustDocument |
decisions and deliberations
|
| gptkbp:oversees |
informed consent process
|
| gptkbp:purpose |
protect rights and welfare of research participants
|
| gptkbp:regulates |
gptkb:Food_and_Drug_Administration
gptkb:U.S._Department_of_Health_and_Human_Services human subjects research |
| gptkbp:requires |
gptkb:United_States_federal_law
gptkb:21_CFR_56 gptkb:45_CFR_46 gptkb:Common_Rule clinical trials Belmont Report principles at least five members at least one nonscientist federally funded research modifications to research protocols at least one member unaffiliated with the institution |
| gptkbp:reviewedBy |
adverse event reports
compensation to participants confidentiality protections continuing review applications potential benefits of research protocol amendments recruitment methods risk to participants vulnerable populations |
| gptkbp:subject |
federal audits
institutional policies |
| gptkbp:bfsParent |
gptkb:Food_and_Drug_Administration
|
| gptkbp:bfsLayer |
4
|