Title 21 Code of Federal Regulations Part 50
GPTKB entity
Statements (26)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:alsoKnownAs |
gptkb:21_CFR_Part_50
|
| gptkbp:appliesTo |
medical device trials
clinical investigations drug trials |
| gptkbp:citation |
gptkb:45_CFR_46
|
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:establishes |
criteria for informed consent
exceptions from informed consent requirements for assent by children requirements for parental permission |
| gptkbp:hasSection |
Subpart D – Additional Safeguards for Children in Clinical Investigations
Subpart A – General Provisions Subpart B – Informed Consent of Human Subjects |
| https://www.w3.org/2000/01/rdf-schema#label |
Title 21 Code of Federal Regulations Part 50
|
| gptkbp:legalCitation |
gptkb:21_CFR_50
|
| gptkbp:partOf |
gptkb:Title_21_of_the_Code_of_Federal_Regulations
|
| gptkbp:publishedBy |
gptkb:U.S._Government
|
| gptkbp:regulates |
protection of human subjects
|
| gptkbp:requires |
informed consent
|
| gptkbp:startDate |
May 30, 1981
|
| gptkbp:subjectArea |
biomedical research
clinical research human research protections |
| gptkbp:bfsParent |
gptkb:Title_21_Code_of_Federal_Regulations_Part_56
|
| gptkbp:bfsLayer |
7
|