pp. 244 in
Bioethics in Asia
Editors: Norio Fujiki and Darryl R. J. Macer, Ph.D.
Eubios Ethics Institute
Copyright 2000, Eubios Ethics Institute
All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.
7.1. Ethical Guidelines for Clinical Genetics in Japan
Shinshu University School of Allied Medical Sciences, Matsumoto, Japan
Clinical genetics has mostly treated single gene disorders, which, in a narrow scope, are genetic diseases, and congenital anomalies. However, recent research has shifted its target to include common diseases such as cancer, diabetes and high blood pressure. gUntil very recently, most concerns and applications were focused on genetic tests for rare, although important, disorders with Mendelian inheritance patterns. The emphasis is now shifting to the common chronic diseases that make up the major health burden in most western countriesh (Harper, PS. 1995, Lancet). Traditionally, medical services have treated disease conditions derived from the interactions between the gene and the environment, now confront the fact that greater efforts have been made to analyze genetically the mechanism of common diseases.
In Western countries rules to match the needs of such target changes are being established. These include the International Rules such as the UNESCO Declaration on the Human Genome and Human Rights, and draft WHO Guidelines on Ethical Issues in Medical Genetics and the Provision of Genetics Services. The common characteristics of guidelines include assurance of adequate informed consent, or providing sufficient information and supporting self-decision either to agree, to deny, or to choose, importance of the pre- and post-testing counseling; improvement of generic support system including psychological support.
In Japanese society, it should be recognized that medical genetics services, as in Europe and US, not only deal with specific diseases any more but include common diseases and are now placed as a part of primary care and public health. With the presupposition of such confrontation of medical genetics services, the ethical, legal, and social issues (ELSI) are growing to be controversial these days. The ethical guidelines should be developed and the inter-disciplinary and open discussion should be urgently encouraged for its development.
Also in Japan several associations have begun developing guidelines such as one developed by the Japanese Association of Familial Cancer. One such attempt by this association is a set of guidelines for genetic testing. The guidelines for genetic testing included an Introduction, 19 Recommendations, an Explanatory Report, emphasizing informed consent, genetic counseling, and protection of genetic information. These guidelines had a unique development process and the following characteristics, which have never before been seen in Japan:
1) The ethics committee which developed the guidelines consists of not only association members but non-members from outside of the medical community. As a result, academic interdisciplinary discussions were facilitated.
2) The guidelines insist upon counseling which takes into account the fact that a strong negative bias against individuals with genetic diseases exists in our society.
3) The guidelines distinguish between research and clinical applications, whose distinctions were ambiguous in the past. The guidelines also refer to the fact that many techniques are still in the process of being tested.
4) The concerned parties were interviewed in the process of developing the guidelines.
This set of guidelines, including its unique developing process, might become an example for other guidelines in Japan. It is possible that similar ethical guidelines will be developed at a professional level.
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