Informed consent in research is a process that enables an individual to make an autonomous decision about participation in a research study.
Informed consent in pediatrics includes parental permission and, as applicable, the assent of the child.
- The term parental “permission” rather than “consent”, distinguishes what a person may do autonomously (consent) from what one may do on behalf of another (grant permission).
- "Assent" is the childs affirmative agreement to participate.
Required documentation of the process includes the signed, IRB approved, informed consent, parental permission and assent forms as well as a summary of the encounter in the medical and/or research record.
Nemours Templates
The Nemours templates for parental permission, assent, and informed consent documents, and short forms for enrollment of non-English speaking participants are located inteh reference library in IRBNet.
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