人類基因資料庫建置與管控之法律問題分析

Abstract

本文旨在探討「人類基因資料庫」（Biobank）在建置與管控過程中所可能面對的法律問題。 隨著生物化學、分子生物學與資訊處理等領域中各種技術的研發創新，世界各國在「人類基因體計畫」（Human Genome Project）完成後，無一不對建立人類基因資料庫展現出濃厚興趣。但是在此同時，人類基因資料庫的建置與管控也連帶地在社會、倫理、法律、醫療、生物研究等層面，帶來了許多新的衝擊與爭議。以過往的諸多歷史發展來看，若放任新興議題自行發展，勢必對人類生活帶來相當大的威脅，並付出更多額外的社會成本。因此，實有必要在著手建置「台灣生物資料庫」（Taiwan Biobank）之同時，就對與之相關的新興議題加以解決與釐清。 由於生物醫學資訊的收集，在生醫領域的研究上扮演著不可或缺的重要地位，是以，第2章透過介紹既往與「人體試驗」有關的重大歷史爭議事件，探討生物醫學資訊收集之必要性，並藉由檢視現行世界各國對人體試驗的相關規範，以瞭解相關規範在建置台灣生物資料庫中所可能產生的影響。 本文第3章先介紹過往已嘗試建置與目前正在進行建置的冰島、愛沙尼亞與英國等3個人類基因資料庫的歷史發展做為基礎，探討與比較目前欲建置台灣生物資料庫的國內發展狀態；第4章則是由3個資料庫在建置與發展過程中曾經出現的爭議與目前現況出發，分析樣本提供者是否可得主張的各項基本權利，如：資訊隱私權（自決權）、財產權與健康權…等。 而過往所發生的各項人體試驗醜聞，已使得社會大眾對於科學的中立性與解決問題的有效性產生質疑，如何適當且有效地管理與監控自「建置台灣生物資料庫」所產生的各項爭議就成為首先需要加以考量的重要課題之一。故第5章乃藉由介紹美、英、德等3國之倫理委員會的設置沿革與台灣現行制度下對人體試驗的監控機制，做為研究台灣是否需要建置國家層級之倫理委員會的基礎，並探討設置台灣國家倫理委員會的必要性。 第6章為省思與建議。本文認為在目前社會整體對於「台灣生物資料庫的設置、使用與管理」等議題尚未達成一定共識的狀況下，實應先設立一個國家層級的獨立倫理委員會，負責統籌來自各界的意見與研究報告等相關資訊後，加以公開給所有民眾參考閱覽，並且針對因創新技術所引發的新興議題適時且有效率地提出建議報告。

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. Due 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.