A policy regarding research in healthy children

Abstract

Children as a group have required special consideration with regard to participation in biomedical research. The Belmont Report I and subsequent federal guidelines for the protection of human subjects participating in biomedical research 2 emphasize that children cannot participate fully in the informed consent process because they may be unable to evaluate the risks and benefits of participation adequately. In reviewing pediatric research projects, the institutional review board must take into account developmental changes from birth to adolescence, assent to participation, response to pain or stress, and appropriateness of a proposed intervention in addition to the worth of the proposed research. Balancing this need for special protection of children is the need for well-collected clinical data useful in the treatment of pediatric disease. Data collected in adults may not be generalizable to children. Because children's diseases are different from those of adults, because there are major developmental differences in physiology between adults and children, and because the usefulness of certain medical treatments may be limited to children, the exclusion of children from medical research is inadvisable. Associated with the dynamic ethical relationship between the need for special protection and the need for specific clinical research in children is the occasional need to include healthy children in research projects. Whereas children with a specific disease may benefit from participation in research or may contribute directly to the benefit of others, healthy children may achieve no medical benefit from participation; the knowledge that others may benefit or