論建置台灣族群基因資料庫應有之法律及倫理規劃

A Study on the Legal & Ethical Planning of a Population-based Genetic Database Establishment in Taiwan

范建得(Chien-Tel Fan) ； 廖嘉成(Chia-Cheng Lao)

《臺北大學法學論叢》 68期 (2008/12) Pp. 95-149

https://doi.org/10.6774/TULR.200812.0095

摘要

近年來，國際間相繼投入可觀的人力與物力資源，利用資訊科技的資料建置管理及運算解析能力，來解釋及探討各種生命現象，例如冰島、日本、英國與其他許多國家的生物銀行或基因資料庫。
而今台灣本著深厚之基因體醫學、臨床研究基礎，亦開始推動「生醫科技島計劃」，其中「台灣族群基因資料庫(Taiwan Biobank)」被認爲是最基礎性的一個計劃。台灣族群基因資料庫計劃的主要效用在於探索生命現象中基因、疾病及環境的交互作用，其成效將能在未來被應用到個人疾病診斷、治療及預防。然因該案牽涉眾多人類基因隱私的揭露，其建置及相關法令規劃已然發展成爲法界觀注的重要課題。
爲充分了解族群基因資料庫建置所生之社會、倫理、法律(ELSI)議題，我國已於2005年8月展開可行性研究計畫，且配合可行性計畫的初步研究成果，於同年年底開始進行台灣族群基因資料庫的先期規劃，對於資料庫之建置所可能衍伸之問題，定當能有更進一步之體認。然而不可否認者，目前國內之法令架構是否已作好完善的準備，亦啟人疑竇，畢竟現有的許多規定皆係以過去之價值觀爲基礎，而隨著越來越多的專家學者投入 ELSI 研究，不少傳統價值觀已遭到挑戰。故此，我國欲建置符合我國國情的法令、監理架構，勢必須對一些既有規範加以檢討。
本文擬先以當前規劃最完善的英國發展經驗爲基礎，先與我國現行相關制度作比較；第二部份則就本文所討論的族群資料庫(population-based Biobank)作一解析，以釐清其與一般的公衛計畫之不同；第三部分係進一步對英國Biobank之生成背景作一簡單之整理介紹；第四部分則係從五個較爲重要的ELSI議題檢視英國之具體因應措施，並相對指出我國之不足所在，且在最後就所指出問題嘗試提出因應策略。

關鍵字

基因資料庫 ； 族群基因資料庫 ； 台灣生物銀行 ； 倫理法律與社會意涵 ； 知情同意 ； 群體同意 ； 利益分享 ； 公眾溝通 ； 公眾參與 ； 人體組織 ； 基因隱私

並列摘要

Recently, taking the advantage of electronic data management and analytical computation capacity development, tremendous amount of human and material resources have been channeled into the biobanking efforts so as to translate and interpret variety types of the life phenomenon, for instances, there have been several biobanks are developed and/or under construction in Iceland, Japan, UK and some other countries.
With the substantial achievement in genomic medical research and basing on a well developed clinical trial infrastructure, Taiwan has initiated a so called ”Island of Biomedical Technology Project.” Among three programs consisted of the project, Taiwan Biobank program was taken as the most fundamental one to the project. The main function of the program has been placed on the exploration of the interaction among gene, disease and environment. In turns, the research can be applied on the personal medical diagnosis, cure and prevention. However, the possible gene privacy disclosure in large scale attracts legal community's attention and the biobanking efforts and related legal/ethical issues become the major concerns as well.
In Taiwan, in the feasibility study started from Aug. 2005, ELSI issues were included as the major topics to be included. At the end of the same year, the pilot study concerning the development of Taiwan Biobank was initiated to cover the extensive ELSI issues of Biobank database development. Certainly, it's deniable that the maturity of contemporary legal system to fit the needs is still in issues. In anyway, the contemporary legal rules are evolved in conjunction with the traditional social value per se. However, its rationality has been highly questioned by the recent ELSI researchers. In turns, a review on the legal and management infrastructure and related rules/norms become necessary, so as to fit the future needs.
In this article, the UK experience will be taken as the most mature example to the initial comparison between UK and Taiwan conditions. In the second part, the significance of a population-based Biobank will be articulated so as to distinguish it from a general cohort study. Thirdly, the article will look into the formulation background of UK Biobank and highlight on the significance of the project. Fourthly, five major ELSI issues will be examined, mainly, in terms of UK Biobank's responsive strategies, so as to find out the shortage of our situation. Finally, several recommendations are proposed for further consideration.

並列關鍵字

Genetic Database ； Population-based Genetic Database ； Taiwan Biobank ； ELSI ； Informed Consent ； Group Consent ； Benefit Sharing ； Public Communication ； Public Engagement ； Human Tissue ； Genetic Privacy

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