Ethics of drug studies in the newborn.

Drug studies in developing pediatric patients, especially newborns, create many ethical challenges that can be analyzed in terms of respect for persons, justice, and beneficence/maleficence as outlined in the Belmont Report. This report describes some of the ethical challenges in conducting drug studies in pediatric patients that must be considered when planning studies and offers some solutions to meet those challenges. Methods of optimal study design should be utilized to limit the number of patients and the number of blood samples. Parental permission should be obtained with equipoise, although the parents of a sick newborn may feel an internal pressure for their child to participate in a study of a new and potentially superior therapy. If appropriate to the study, consent before labor and delivery when parents are less stressed is optimal. It may be difficult or impossible to know all the risks and benefits accompanying studies in newborns due to the limited number of randomized controlled studies in this population. Many more carefully designed, randomized controlled studies of drugs are needed to address the therapeutic needs of the developing pediatric population. For sick newborns cared for in the neonatal intensive care unit (NICU), those studies should be better focused on the drugs used daily in their cares.