be concerned about financial or public relations consequences of adverse experiences in research involving children.

As recounted in Chapter 1, reactions against abusive or questionable research practices involving both adults and children have led to an evolving set of policies and practices to protect all human participants in research, with additional protections for children and other vulnerable populations. The adoption of special protections for child research participants and the growing awareness of researchers’ ethical obligations have curbed what are now regarded as unethical and harmful research practices. Notwithstanding these benefits, some of these protections have also made some research involving children more administratively burdensome in certain respects than research involving adults. Debate continues about what constitutes an appropriate balance between scientific priorities and protection of child participants in research.

Later sections of this chapter describe further the rationale and complex requirements for valid, safe pediatric research. The next section discusses the different definitions of infants, children, and adolescent used in different research contexts.

DEFINITIONS: INFANTS, CHILDREN, AND ADOLESCENTS

From birth into adulthood, children change and develop physically, cognitively, socially, and emotionally. Although these changes are fairly predictable, parents, clinicians, and others who interact regularly with children recognize that children of the same chronological age may develop at different rates. Practical and legal considerations, however, often dictate the organization of services and the definition of legal rights and other policies based primarily or entirely on chronological age.

Legal issues aside, age breakdowns are “a basis for thinking about study design in pediatric patients” (ICH, 2000b, p. 7). The age range specified for particular clinical studies will depend on the research question, for example, whether it involves a condition specific to infants or whether previous research shows relevant age-related physiological differences. The choice of age ranges may also be shaped by policy considerations, research organization missions, convenience, and other factors. Thus, in guidance on drug testing, FDA may reasonably define adolescence more narrowly than other agencies based on considerations of developmental physiology related to how drugs work in the body. A broader adolescent age range, however, is reasonable for the Centers for Disease Control and Prevention (CDC) and other agencies interested in the contribution of adolescent behavior, including risk taking, to problems such as sexually transmitted disease and motor vehicle-related deaths and injuries.



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