Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
clinical investigations regulated by the FDA
|
| gptkbp:citation |
gptkb:21_CFR_50
gptkb:21_U.S.C._346 gptkb:21_U.S.C._355(i) gptkb:21_U.S.C._360j(g) |
| gptkbp:establishes |
requirements for suspension or termination of IRB approval
requirements for IRB functions and operations requirements for IRB membership requirements for IRB records requirements for IRB reporting requirements for IRB review of research requirements for expedited review procedures requirements for informed consent review |
| gptkbp:fullTitle |
gptkb:Title_21_Code_of_Federal_Regulations_Part_56
|
| https://www.w3.org/2000/01/rdf-schema#label |
21 CFR 56
|
| gptkbp:purpose |
to protect the rights and welfare of human subjects in clinical investigations
|
| gptkbp:regulates |
gptkb:Institutional_Review_Boards
|
| gptkbp:requires |
review and approval of research by an IRB
|
| gptkbp:startDate |
January 27, 1981
|
| gptkbp:bfsParent |
gptkb:institutional_review_boards
|
| gptkbp:bfsLayer |
5
|