CFR section
21 CFR 50.55(a): 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(a) |
|---|---|
| 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) | (a) In addition to the determinations required under other applicable sections of this subpart D, the IRB must determine that adequate provisions are made for soliciting the assent of the children when in the judgment of the IRB the children are capable of providing assent. |
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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.