Consent Overview


Consent:  "Consent" involves the act of the will, based upon legal rights of the consenter, which requires the individual to be 18 years of age or older. Individuals who have appropriate decisional capacity and legal empowerment can give their informed consent. Consent embodies judgments about proposed interventions and, more importantly, consent expresses something for one's self: a person who consents responds based on unique personal beliefs, values, and goals.

Minor / Children:  "Children" are persons who have not attained the legal age for consent (18 years of age in most states), and thus cannot legally provide "consent" to treatments or procedures involved in research.

Assent: "Assent" means a child's affirmative agreement to participate in research. It is an act signifying understanding (recognizing that the minor has not reached full legal age). Mere failure to object by the child should not, absent affirmative agreement, be construed as assent.

Permission: "Permission" means the agreement of parent(s) or guardian to the participation of their child or ward in research. Unless waived, parents must provide their permission (parental consent) to allow their child to participate in the research study. [NOTE: Unless waived, there must be a signed Parental Permission (Consent) form on file for each participating minor. "Passive" consent , i.e., sending the child home with a form which states "please let us know if you don't want your child to participate", and then in the absence of a response (failure to object) from the parent, construing this to mean agreement that the child can participate, is not allowable.]

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