「臺灣人體生物資料庫」發展歷程與ELSI困境

Development of Taiwan Biobank: Ethical, Legal, and Social Implications (ELSI)

臺灣生醫科技島計畫為政府所擬定並啟動之國家重大研發及產業政策，其計畫之主要的內容，乃在於利用現代化資訊科技之資料建置，以實證為基礎，探索生命現象中遺傳資訊、疾病及環境的交互作用，並整合政府重要生醫資訊相關計畫。其中建置「臺灣人體生物資料庫（簡稱Taiwan Biobank）」執行迄今已多年，但仍發生倫理適切性疑慮，造成「臺灣人體生物資料庫」時常必須停擺之困窘。本文首先回顧人體生物資料庫發展歷程，第二部分，探討目前Taiwan Biobank對倫理、法律及社會風險（Ethical, legal and social implications, ELSI）之因應策略，特別針對「參與者之直接利益」、「參與分配研究成果所生利益」以及「族群基因汙名化的風險」議題進行分析。第三部分探討Taiwan Biobank倫理委員會有關倫理治理機制與倫理審查機制之交錯監管議題。

In April 2005, the Taiwanese government launched a Biomedical Technology Island Plan. The plan is comprised of three main projects: the National Health Information Infrastructure, Taiwan Biobank, and Clinical Trials Service. The creation of Taiwan Biobank has been included as a part of Biomedical Technology Island Plan and is proposed to build a large scale population biobank to support biotech development and medical research in Taiwan. Criticisms from a range of stakeholders, including the Taiwan Association of Human Rights, has led to postponements in the establishment and created complications in the operation of Taiwan Biobank. The first part of the study reviews the history of the Taiwan Biobank establishment, while the second part explores the current strategies of Taiwan Biobank on ethical, legal, and social risks; specifically, for the issues of “the interests of participants", "the benefits of participating in the distribution of Taiwan Biobank" and “the risk of population genetic discrimination”. The third part explores the intertwined regulatory issues of the Ethical Committee of Taiwan Biobank on ethical governance mechanisms and ethical review mechanisms.