Informed consent in research is a process that enables an individual (or parent or guardian) 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.
Keep these distinctions in mind:
- Consent: pertains to what a person may do autonomously
- Permission: is granted on behalf of another
- Assent: is a child’s 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. The Nemours templates for these forms, plus short forms for enrollment of non-English-speaking participants, are located in the reference library in IRBNet.