Assent by Children
Guidance on assent by children
Assent means a child's affirmative agreement to participate in research, including a clinical investigation. The mere failure of a child to object may not be construed as assent unless there is an affirmative agreement by the child to participate. (21 CFR 50.3(n); 45 CFR 46.402(b)).
When possible and appropriate, adequate provisions should be made for soliciting assent from children (individuals who are under 18 years of age) to participate in a research study. In some cases, particularly for research that is not intended to be therapeutic, the IRB may request that an age-appropriate assent form or an assent script be developed.
Investigators who plan to enroll children in their protocols should describe in their protocol applications the assent process that will be followed, taking into account the age ranges of the children, as well as the maturity and physical and psychological state of the children.
Even if a child is too young to provide assent, investigators should consider and describe in their applications to the IRB how the investigator will identify and respond to situations where the child does not want to participate. Respect for a child’s unwillingness to participate is especially critical in research that does not have a therapeutic intent and that exposes the child to some risk.
For more information regarding the assent requirements for research participants who are children, see 45 CFR 46, Subpart D(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html) and 21 CFR 50, Subpart D (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm).