Subpart D: Additional Safeguards for Children in Clinical Investigations
URI: https://gptkb.org/entity/Subpart_D:_Additional_Safeguards_for_Children_in_Clinical_Investigations
GPTKB entity
Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
|
| gptkbp:appliesTo |
FDA-regulated clinical investigations
clinical investigations involving children |
| gptkbp:basisFor |
Belmont Report ethical principles
|
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:hasSection |
50.55
50.50 50.51 50.52 50.53 50.54 |
| https://www.w3.org/2000/01/rdf-schema#label |
Subpart D: Additional Safeguards for Children in Clinical Investigations
|
| gptkbp:partOf |
gptkb:21_CFR_50
|
| gptkbp:protectedBy |
children as a vulnerable population
|
| gptkbp:purpose |
to provide additional protections for children involved as subjects in clinical investigations
|
| gptkbp:regulates |
informed consent for children
risk-benefit analysis for pediatric research |
| gptkbp:requires |
child assent
parental permission |
| gptkbp:section |
21 CFR 50 Subpart D
|
| gptkbp:startDate |
April 30, 2001
|
| gptkbp:bfsParent |
gptkb:21_CFR_50
|
| gptkbp:bfsLayer |
7
|