Bioethics in human gene analysis and international view

目的：个人信息保护法于2005年4月1日起实施。遗传信息的收集和分析应当依照本法进行。遗传信息绝对是“个人的”，使用遗传信息的研究应该仔细计划和执行。我们要求一些医疗和研究机构制定与这项新法律有关的规章制度。为了进行国际比较，收集了中国生物伦理学的相关信息。利用生物技术进行人体基因分析的实验工作也在进行。结果和讨论：在所有被调查的机构中，新法律得到了认真和广泛的讨论。各机构伦理委员会决定遵守法律，并在所有调查机构严格执行匿名规定。接收非直接来自人类受试者的人类材料的机构特别小心，只接收匿名材料。分析基因数据的计算机没有连接电话线。所有接受调查的机构都采取了这种脱机处理遗传数据的做法。在中国，已经出版了几本关于遗传咨询的书。这是非常令人印象深刻的，因为直到大约10年前，中国基本上还不存在生命伦理学。在近畿大学的遗传咨询研究生课程中，我们根据个人信息保护法成立了生命伦理委员会。这种考虑也适用于对原子弹幸存者的调查。

Objective :The law for protection of personal information was enforced on April 1, 2005. Collection and analysis of genetic information should be carried out according to this law. Genetic information is definitely "personal" and researches with genetic information should be carefully planned and performed. We asked several medical and research institutions for rules and regulations related to this new law. For international comparison, information concerning bioethics in China was collected. Experimental work also was carried out using biotechnology for gene analysis in humanResults and discussion :The new law was carefully and extensively discussed in all institutes surveyed. Institutional ethics committees decided to follow the law and regulation for anonymity was strictly enforced in all institutions surveyed. Institutions receiving human materials not directly from human subjects are particularly careful to receive anonymized materials only. Computers analyzing genetic data are not connected to telephone lines. Such off-line handling of genetic data has been taken care of in all institutions surveyed. In China, several books on genetic counseling have been published. This is very impressive as bioethics was essentially non-existing in China until about 10 years ago. In our new graduate course for genetic counseling at Kinki University, we established a bioethics committee, in accordance with the personal information protection law. Such consideration was also applied for the survey of atomic bomb survivors.