What is the definition of guardian in the context of obtaining consent for research involving children?
The term guardian means “an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care” (45 CFR 46.402(e)) The role of a guardian in the context of research involving a child who is a ward is to provide permission, in lieu of a child’s biological or adoptive parents, for the ward to participate in the research (45 CFR 46.402(c)). For a more extensive discussion see FAQs on Research with Children.
Related Questions
- When should an Institutional Review Board (IRB) or institution request a "407" review for research involving children as subjects?
- What is the definition of guardian in the context of obtaining consent for research involving children?
- Can parental or guardian permission for research involving children be waived?
