Abstract
Governmental regulations and external review mechanisms for biomedical research were introduced in Japan in the late 1980s. However, there are two major problems yet to be overcome: 1) lack of a clear definition of research and 2) inconsistency among regulations for the protection of participating human subjects. In this paper, I discuss these two problems referring to the recent development of administrative guidelines over biomedical research in Japan. Regarding the former, the 2007 version of the Guidelines for Epidemiological Research introduced a standard for the distinction between research and medical practice. However it does not tell us how the gray zone between research and practice should be regulated. Regarding the latter, the 2008 version of the Guidelines for Clinical Research introduced a stricter regulation for those clinical trials which use already approved drugs or medical devices. Although these new guidelines lead to more consistent regulations, there is still a significant difference among guidelines regarding their binding powers.
