CFR section
21 CFR 50.55(e)(2): Requirements for permission by parents or guardians and for assent by children
PART 50-PROTECTION OF HUMAN SUBJECTS · Subpart D-Additional Safeguards for Children in Clinical Investigations
Key facts
| Citation | 21 CFR 50.55(e)(2) |
|---|---|
| Section | Requirements for permission by parents or guardians and for assent by children |
| Part | PART 50-PROTECTION OF HUMAN SUBJECTS |
| Subpart | Subpart D-Additional Safeguards for Children in Clinical Investigations |
| Subchapter | 21 CFR A General |
| Product types cited | Drugs, General |
| Regulation text (excerpt) | (2) Where clinical investigations are covered by § 50.53 or § 50.54 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.