CFR section
21 CFR 50.55(c): 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(c) |
|---|---|
| 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 | General |
| Regulation text (excerpt) | (c) The assent of the children is not a necessary condition for proceeding with the clinical investigation if the IRB determines: (1) That the capability of some or all of the children is so limited that they cannot reasonably be consulted, or (2) That the intervention or procedure involved in the clinical investigation holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the clinical investigation. |
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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.