The Legal Problems in Construction and Management of Biobank
Date Issued
2009
Date
2009
Author(s)
Lee, Tai-Hsiuan
Abstract
This research is about the legal problems in establishment and construction of biobank. Following the innovative techniques in biochemistry, molecular biology and data processing, various countries are devoted to the current trend of biobank estabalishment after the completion of Human Genome Project. Meanwhile, new impact and issues have arised from social, ethical, legal, medical and biological research in setting up biobank. The former cases have proven that if emerging issues unrestrictly develop, it will pose a greater threat to modern human life and consume more social cost. Therefore, it is necessary to regulate and sovle the emerging issues in the beginning of biobank estabashiment.ue to the requisite status of data collection in medical treatment procedure, the historical dispute event, the related convention and international guidelines of human experiment are introduced to study the necessity of biomedical information gathering in biomedical research field and to analysis the possible effect on biobank estabalishment project. After reviewing the founding history of three biobanks, Island, Estonia and United Kingdom, and the emerging issues during the biobank construction process, this article examines the sample doner’s fundamental right, such as privacy, property right and health right, in the fisrt place. Therefore, how to effectively control and monitor the emerging issues of social, ethical, legal, medical and biological research in biobank establishment process must be taken into consideration above all. Following a comparison of the national ethics committee of United States, United Kingdom and Germany, the significance of independent national ethic committee of Taiwan biobank seems needed. Complications may arise when individual and community interests confiicts. In this paper, the point of view is the government had better protect the benefit and interests of both the biomedical research community and the public equally by thoughtful regulations and well performed assessment strategies. The concern for confidentiality, respect of every individual opinion, transparency, and the donor''s right to access to their own result must be bring into effect as basic principles. For this reason, a national ethics committee must be set up to be responsible for the discussionof all emerging issues in Taiwan biobank construction program.
Subjects
biobank
privacy
property right
health right
human experiment
ethic committee
SDGs
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