| Budget Amount *help |
¥2,400,000 (Direct Cost: ¥2,400,000)
Fiscal Year 1999: ¥800,000 (Direct Cost: ¥800,000)
Fiscal Year 1998: ¥700,000 (Direct Cost: ¥700,000)
Fiscal Year 1997: ¥900,000 (Direct Cost: ¥900,000)
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| Research Abstract |
In this research, I studied the legal and ethical problems of clinical research.
After obtaining a rough sketch of Japanese practice, I studied the historical developments in and the present framework of the regulation of the clinical research in the United States. There are two kinds of regulation by the federal govemment. First is the regulation of the research conducted or funded by the federal departments or agencies. Second is the regulation by the Food and Drug Administration of the clinical trial of new drugs. I focused my attention on the first, because it has been more influential. The Department of Health, Education and Welfare, and later, the Department of Health and Human Services has taken the lead in the field. In 1991, the so-called "Common Rule" which was modeled on the DHEW's regulations was promulgated. The features of the Common Rule are : (1) the requirement of submission by the institutions of assurance of the protection of human research subjects ; (2) the requirement of the establishment of institutional review board (IRB), (3) the requirement of informed consent as the comerstone of the subject's protection.
In the fall of 1999, the burst of ethical guidelines began in Japan. The Ministry of Health and Welfare's "Guidelines on Ethical Issues Surrounding Genetic Analysis Research (2000), " the Council for Science and Technology's "Fundamental Principles of Research on the Human Genome (2000)" and "Ethics Guidelines on Human Genome and Genetic Research (2001)" of three responsible ministries are prominent among them. The issues of stored samples and general consent and the problem of the permissibility and obligation of disclosing the subject's genetic information to his relatives are common to most sets of guidelines. It is suggested that understanding among people is prerequisite to the concept of general consent to the participation in research.
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