Ethical and legal issues in pediatric drug research.

Clinical pharmacology in pediatrics has been impeded for a number of years by ethical and legal issues which have been impossible to resolve by individual investigators and by society at large. The ethical issues involved in such research, in children, have been defined more clearly in the recent past and investigators now have a number of guidelines to follow in constructing and carrying out their studies. The ultimate legal status of clinical pharmacology studies in children is still to be defined, but sensitive investigators who work with competent institutional review boards should be able to advance our knowledge through clinical studies in children without major liability.