Children comprise a large subgroup of patients with human immunodeficiency virus (HIV) infection, and their treatment must be defined by pediatric clinical trials. Children's participation in research trials requires the fully informed consent of the parent or legal guardian,1 to whom most of the information is commonly directed.2 However, for nontherapeutic trials, the Code of Federal Regulations also requires that assent (the “affirmative agreement to participate in research”) be obtained from children at appropriate developmental ages.3 It also assigns to institutional review boards (IRBs) the duty to “determine that adequate provisions are made for soliciting the assent of the children . . . capable of providing assent.”3
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