The distinction between clinical research and clinical practice directs how we partition medicine and biomedical science. Reasons for a sharp distinction date historically to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, especially to its analysis of the “boundaries” between research and practice in the Belmont Report (1978). Belmont presents a segregation model of the research-practice distinction, according to which research and practice form conceptually exclusive sets of activities and interventions. This (...) model is still the standard in federal regulations today. However, the Commission’s deliberations and conclusions about the boundaries are more complicated, nuanced, and instructive than has generally been appreciated. The National Commission did not conclude that practice needs no oversight comparable to the regulation of research. It debated the matter and inclined to the view that the oversight of practice needed to be upgraded, though the Commission stopped short of proposing new regulations for its oversight, largely for prudential political reasons. (shrink)

To address some questions in global biomedical ethics, three problems about cultural moral differences and alleged differences in Eastern and Western cultures are addressed: The first is whether the East has fundamentally different moral traditions from those in the West. Concentrating on Japan and the United States, it is argued that theses of profound and fundamental East-West differences are dubious because of many forms of shared morality. The second is whether human rights theory is a Western invention with no firm (...) traditions in Eastern moral traditions. It is argued that this thesis is unsupported both historically and in contemporary bioethics. The third problem is whether multiculturalist theory casts doubt on claims of universal principles and rights. It is argued that the reverse is true: multiculturalism is a universalistic theory. The argument throughout supports common morality theory. (shrink)