CFR section
21 CFR 50.55(b): 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(b) |
|---|---|
| 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) | (b) In determining whether children are capable of providing assent, the IRB must take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in clinical investigations under a particular protocol, or for each child, as the IRB deems appropriate. |
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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.