Statements (24)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
biological product trials
medical device trials clinical investigations drug trials research involving FDA-regulated products |
| gptkbp:enforcedBy |
FDA Office of Good Clinical Practice
|
| gptkbp:establishes |
requirements for informed consent
requirements for parental permission and assent exceptions from informed consent |
| gptkbp:focusesOn |
informed consent
|
| https://www.w3.org/2000/01/rdf-schema#label |
21 CFR Part 50
|
| gptkbp:legalCitation |
21 CFR § 50
|
| gptkbp:partOf |
gptkb:Title_21_of_the_Code_of_Federal_Regulations
|
| gptkbp:regulates |
protection of human subjects
|
| gptkbp:relatedTo |
gptkb:21_CFR_Part_56
45 CFR Part 46 |
| gptkbp:requires |
documentation of informed consent
voluntary participation disclosure of risks and benefits |
| gptkbp:startDate |
1978
|
| gptkbp:bfsParent |
gptkb:21_CFR_50
|
| gptkbp:bfsLayer |
7
|