Understanding the research-care demarcation and why it must be revised.

ABSTRACT

BACKGROUND: A clean-cut separation between research and care was artificially created at the time of the Belmont report more than 40 years ago. The demarcation was initially controversial but eventually was implemented for political reasons. We examine why it must be revised. METHODS: We review historical research scandals as well as the theoretical basis for the Belmont demarcation. We then discuss consequences on medical practice and propose an alternative. DISCUSSION: Most research scandals involved abusing human beings supposedly for the sake of science. Belmont commissioners were aware the research/care problem was double-headed. While research subjects should be protected from abuse in the research context, patients need to be protected from unvalidated medical and surgical interventions in the care context. For political reasons the Commission recommended the regulation of research but to leave medical practice untouched. Thus the Commission had to distinguish research from care. The notion of 'generalizable knowledge' was introduced to define and regulate research, but the inadvertent result was that by trying to protect research subjects, the regulation has not only failed to protect all other patients, but also encouraged the widespread practice of unvalidated interventions within the care context. The notion of validated care should be re-introduced into a proper analysis of the care-research demarcation, for care research is an integral ingredient of a good medical practice. CONCLUSION: The research-care demarcation should be revised to leave room for the validated/unvalidated care distinction. Care research, essential to guide medical practice, should be facilitated at all levels.