| Summary: | 碩士 === 國立清華大學 === 科技法律研究所 === 100 === 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.
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