Statements (22)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:appliesTo |
biological product trials
medical device trials clinical investigations drug trials |
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| https://www.w3.org/2000/01/rdf-schema#label |
21 CFR 50
|
| gptkbp:includes |
requirements for informed consent
requirements for parental permission and assent |
| gptkbp:legalCitation |
gptkb:21_CFR_Part_50
|
| gptkbp:partOf |
gptkb:Title_21_of_the_Code_of_Federal_Regulations
|
| gptkbp:publishedBy |
gptkb:U.S._Government_Printing_Office
|
| gptkbp:purpose |
to protect the rights and welfare of human subjects in research
|
| gptkbp:regulates |
protection of human subjects
|
| gptkbp:relatedTo |
gptkb:45_CFR_46
|
| gptkbp:requires |
IRB review of consent process
documentation of informed consent |
| gptkbp:section |
gptkb:Subpart_D:_Additional_Safeguards_for_Children_in_Clinical_Investigations
Subpart B: Informed Consent of Human Subjects |
| gptkbp:startDate |
1978
|
| gptkbp:bfsParent |
gptkb:21_CFR_56
|
| gptkbp:bfsLayer |
6
|