Assent Process

Assent is a child's "affirmative agreement" to participate in research. Federal regulations require that assent be obtained directly from the child/adolescent in addition to written parental/guardian permission. Assent is required unless the subject is incapable of providing it because of immaturity or cognitive abilities.

In general, it is felt that children 7 - 17 years of age may be capable of providing assent. However, individual subjects or populations of subjects may not have the cognitive and emotional maturity to understand the research project and decide whether or not to participate.

To obtain assent and informed consent, a child, adolescent parent or guardian must fully understand the purpose of the research, the procedures, risks and benefits, alternative options, the voluntary nature of participation, how privacy will be assured, whether they will receive any compensation or reimbursements and other factors that may influence a decision to participate. Information must be presented simply and in a straightforward manner. The child should be given an explanation of the proposed research procedures that is appropriate to her age, experience, maturity, and condition. This explanation should include a discussion of any discomforts and inconveniences the child may experience if she agrees to participate.