involve children in discussions about research and obtain their assent to participation.

Although debate continues about the ethical dimensions and boundaries of parental permission and child assent, especially when adolescents are involved, much attention today focuses on more practical questions about how to interpret and implement these concepts and honor their underlying ethical principles in research practice. For example, at what age should investigators, as a general rule, begin seeking a child’s assent? What information and what role in decision making are appropriate for children at different stages of development? How should relationships between children and parents be approached?

This chapter considers two elements in the charge to the committee. The first relates to the written and oral process for obtaining assent and permission for research participation from children and their parents, guardians, or other legally authorized representatives.1 The second involves an examination of children’s and parent’s expectations and comprehension of the direct benefits and risks associated with a child’s participation in research and, in particular, their understanding of the distinction between research and treatment. The discussion begins with an overview of the ethical principles and legal requirements for obtaining parents’ and children’s agreement to a child’s participation in research, including circumstances in which minors can make decisions on their own behalf. Next is a review of the literature relevant to parents’ and children’s understanding of research participation, which also covers the general research literature on the development of children’s cognitive and decisional capacities. The last sections of the chapter offer recommendations.

ETHICAL PRINCIPLES AND LEGAL REQUIREMENTS

The Ethics of Informed Consent, Permission, and Assent

For pediatric ethics, informed consent is more properly understood as a combination of informed parental permission and (when appropriate) the assent of the child.

Kodish, 2003b, p. 90

As described in Chapter 1, the ethical principle of respect for persons underlies the obligation of investigators to treat individuals as autonomous actors who must provide their informed and voluntary consent to partici-

1  

For simplicity, the rest of this chapter will refer only to parents.



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