Neonatal pain relief and the Helsinki Declaration.

The Helsinki Declaration is the universally accepted standard for ethical behavior in research involving human subjects. The Declaration calls for research studies to compare new therapies to the best current therapies. Despite this standard, multiple studies of pain relief interventions in newborns have recruited placebo controls instead of active controls using the best current therapy. These studies are evaluated using the standards required by the Helsinki Declaration, and the reasons for the ethical shortcomings of these studies are explored.