Abstract

Special moral, regulatory, and scientific questions surround the inclusion of children in health-related research. These questions arise from a fundamental moral tension between the obligation to expose children to research participation to ensure that they share in the benefits that arise from it and the obligation to protect them from the harms associated with their inappropriate involvement in research. This tension is felt in the development of moral and regulatory frameworks for the protection of child research subjects and in the implementation and interpretation of these frameworks by institutional review boards