為建立全國性的本土生物資料庫,「台灣人體生物資料庫(Taiwan Biobank」歷經可行性計畫、先期規劃與延續計畫等計畫之評估與規劃,即將邁入正式成立的階段。「台灣人體生物資料庫」建置目的,係為採集與儲存參與者之生物檢體、個人資料與其他相關資料、資訊,供生物醫學研究使用,以達到促進國民健康與發展個人化醫療之長期目標。然而,生物資料庫建置的過程亦涉及倫理、法律與社會意涵,因此生物資料庫應建立適當的倫理治理機制,以確保生物資料庫的管理與運作係符合法律與倫理規範。「人體生物資料庫管理條例」於民國99年制定,就生物資料庫之倫理治理進行規範。值得注意者為,「台灣人體生物資料庫」之治理並非上述專法制定後始成形,而是該議題於資料庫建置初期即受關注,並已進行相關研究與規劃。此時,「人體生物資料庫管理條例」將治理機制予以法制化,究竟對「台灣人體生物資料庫」,有何影響?本文首先探討生物資料庫治理原則與治理機制,並釐清人體生物資料庫之法律框架與倫理規範。再分析「台灣人體生物資料庫」,於立法前與立法後,所採取之不同治理機制,據以探討「人體生物資料庫管理條例」之制定,對「台灣人體生物資料庫」倫理治理之影響。
Taiwan Biobank is a national population-based biobank initiative that went through several assessment projects and now reaches its final review for official establishment. By collecting biological samples, health data and life style data from participants, Taiwan Biobank aims to provide valuable resources for bio-medical research and thus contributes to promote better health care and to develop personalized medicine. However, development of biobank involves ethical, legal and social implications (ELSI) and sometimes even raised controversies. To ensure that biobank operation and management are conformed to ethical and legal requirements, adequate governance needs to be established. The Human Biobank Management Act (Biobank Act), enacted in 2010, provides legal foundation for Taiwan Biobank ethical governance. Notice that, before the legislation, biobank governance is already a major concern during assessment projects of Taiwan Biobank. We therefore understand that governance is an evolving issue that requires continuous consideration. Then, what is the role of legislation in promoting adequate biobank governance? In this thesis, I will first clarify the definition of biobank governance and its mechanisms. Then, the current legal framework and ethical principles of Taiwan Biobank governance will be presented. Finally, different governance mechanisms adopted to solve the evolving ELSIs, before and after the enactment of Biobank Act, will be analyzed. Through the Taiwan Biobank experience in a timeline, the role of legislation in biobank governance will be explored.