It is recognized that improvement in the practice of clinical medicine, including confirmation of the safety and efficacy of some current interventions, depends greatly on the pursuit of appropriate research. It therefore follows that improved clinical care of children depends on their participation in pediatric research. Furthermore, in the absence of relevant research, harm to children may result. Thus formal studies of therapeutic modalities in children is seen as a moral imperative to ensure that children have equal and safe access to existing and new agents (1 ).