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In This Section
Minors Who Can Consent for Themselves
Who is a Child (and who is not)?
45 CFR 46.402 - Definitions
(a) Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction where the research will be conducted.
(b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
(c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.
(d) Parent means a child's biological or adoptive parent.
(e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care. (A guardian is the equivalent of a legally authorized individual acting on behalf of an incapacitated adult.)
Note: The FDA definition uses the term clinical investigation instead of research but is otherwise the same.
Most of the research protocols active at CHOP involve children as research subjects. Understanding the regulations governing participation of children in research is vital.
Children are neither legally nor developmentally capable of consenting to their own treatment or participation in research. No one can consent for an individual other than that person. As a result, a proxy, such as a parent, must provide permission in lieu of consent and children who are deemed capable, must provide their assent.
In order to decide whether or not the additional protections of Subpart D apply, the IRB must first determine if any of the subjects will be children.
The definition of who is a child varies by state because the laws regulating when children may consent for treatment varies. In Pennsylvania, New Jersey and Delaware the age of majority is 18 years but there are many situations where minors may consent to their own treatment prior to turning 18. Whenever a minor can consent to treatment, the minor is not considered a child under the regulations and may consent for themselves provided that they have the capacity to protect their own interests and the research is related to the care for which they have consented. The Guttmacher Institute provides An Overview of Minors’ Consent Law on their website. The Overview summarizes a minor's right to consent for sexual or reproductive health services, state by state.
The CHOP Policy on Consent, located in the Patient Care Manual outlines the circumstances under which a minor may consent for their own treatment. IRB SOP 505 includes additional information including specifics for the states (PA, NJ and DE) served by CHOP and its satellites.