Researchers promoting epidemiologic studies and clinical studies must respect the Use Limitation Principle in the Organization for Economic Co-operation and Development (OECD) Guidelines on the Protection of Privacy and Transborder Flow of Personal Data in 1980. About the ethical issues on medical research, the national government in Japan has published 4 kinds of guidelines according to the study design; “Guidelines for researches about human genome and gene”, “Guidelines for clinical researches about gene treatment”, “Guidelines for clinical researches”, and “Guidelines for epidemiologic researches”. The “Guidelines for researches about human genome and gene” and “Guidelines for clinical researches about gene treatment” require subjects' informed consent in all the studies; therefore, there is no violence of the Use Limitation Principle. On the other hand, on the guidelines about clinical researches and epidemiologic ones, researchers using just only the existing data, such as individual clinical records, can use the data without informed consent with some processes, such as the approval of the institutional review board (IRB) and public offering of the information about the research according to the guidelines. These articles are reasonable because in some types of epidemiologic studies, such as studies for disease frequency, it violate the scientific accuracy due to selection bias if the researchers can use only data of those with informed consent. From the view point of the principle of individual participation, it should become better systems if the participants are able to know the fact that their data are used in the study even in the researched in which informed consent is not required according to the guidelines. Because the current rules in Japan are not acts but the guidelines, however, researchers using clinical data secondarily are in an awkward positions, and the situation should be improved.
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