CFR section
21 CFR 50.56(b): Wards
PART 50-PROTECTION OF HUMAN SUBJECTS · Subpart D-Additional Safeguards for Children in Clinical Investigations
Key facts
| Citation | 21 CFR 50.56(b) |
|---|---|
| Section | Wards |
| 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) If the clinical investigation is approved under paragraph (a) of this section, the IRB must require appointment of an advocate for each child who is a ward. (1) The advocate will serve in addition to any other individual acting on behalf of the child as guardian or in loco parentis. (2) One individual may serve as advocate for more than one child. (3) The advocate must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for… |
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