Balancing Disclosure of Diagnosis and Assent for Research in Children With HIV

Abstract

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, to whom most of the information is commonly directed. 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. 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.” Truly meaningful assent requires that children’s conditions be appropriately disclosed to them. However, disclosure of diagnosis to children with HIV is a complex issue that, when poorly managed, can cause harm to the child and family. For various reasons, parents may be reluctant to allow disclosure of HIV infection to their child. They often worry that children will not exercise discretion and that the child or family will be stigmatized. Cases of maternally transmitted HIV infection may be complicated by parental guilt and a desire to avoid further harm to the child through premature disclosure. Therefore, 3 important questions arise. Can a child who has reached the age of assent participate in pediatric HIV research without knowing his or her diagnosis of HIV or AIDS? What does “disclosure of diagnosis” mean in the context of pediatric HIV? What should be the response of a clinician or researcher when a parent of a child who has reached the age of assent will not agree to a developmentally appropriate process of disclosure? In this Commentary, we consider these questions and offer a practical stepwise disclosure method. Research Participation Without Knowing the Diagnosis