Bioethical and Regulatory Issues in Newborn Medical Research

Current federal research regulations for the protection of human subjects are designed to uphold 3 basic ethical principles: respect for persons, beneficence, and justice. Research investigators and institutional review boards share responsibility for applying these principles through optimizing informed consent, minimizing research risks, and selecting subjects equitably. Children are afforded additional regulatory protections, and research involving neonates in particular carries unique challenges to successful implementation of these core ethical principles. Further complications arise from alternate interpretations of research regulations, an inevitable part of the struggle to keep pace with continuous and rapid advances in medical practice.