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Raymond C. Barfield, MD, PhD; Javier R. Kane, MD

JAMA. 2008;300(5):576-578.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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

Truly meaningful assent requires that children's conditions be appropriately disclosed to them.⁴ However, disclosure of diagnosis to children with HIV is a complex issue⁵ that, when poorly managed, can cause harm to the child and family.⁶ For various . . . [Full Text of this Article]

Research Participation Without Knowing the Diagnosis

Author Affiliations: Department of Oncology (Drs Barfield and Kane), Palliative and End-of-Life Care Program (Dr Kane), and Ethics Committee (Drs Barfield and Kane), St Jude Children's Research Hospital, Memphis, Tennessee. Dr Barfield is now with Duke University, Durham, North Carolina.