: The Convention on Human Rights and Biomedicine developed by the Council of Europe, now undergoing ratification, is the first international treaty focused on bioethics. This article describes the background of the Convention's development and its general provisions and provides a comparison of its requirements with those of federal regulations governing research with human subjects. Although most provisions are comparable, there are significant differences in scope and applicability, for example, in the areas of compensation for injury, research participation by persons (...) with limited capacity to consent, assisted reproduction, organ transplantation, and research in emergency situations. The Convention represents a milestone in international bioethics and protection of human rights that will probably be referred to with increasing frequency. (shrink)