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.

I.In English

A.Articles
Anne Cambon-Thomsen, The social and ethical issues of post-genomic human biobanks, 5 Nature Review Genetics 866 (2004).
A. Cambon-Thomsen, E. Rial-Sebbag and B.M. Knoppers, Trends in ethical and legal frameworks for the use of human biobanks, 30 Eur Respir J 373 (2007).
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Chien-Te Fan, Jui-Chu Lin, Chung-His Lee, Taiwan Biobank: a project aiming to aid Taiwan’s transition into a biomedical island, 9 Pharmacogenomics (2008).
Cutter AM, Chadwick R, Wilson S, Balancing Powers: examining models of biobank governance, 1 J Int Biotechnol Law 187 (2004).
Dany Doiron, Parminder Raina, Vincent Ferretti, Francois L’Heureux & Isabel Fortier, Facilitating collaborative research: Implementing a platform supporting data harmonization and pooling, 21 Norsk Epidemiologi 221 (2012).
Donna M. Gitter, The application of data access policies designed for genome-wide association studies to smaller scale databases, 10 J Marshall Rev. Intell. Prop. L 476 (2011).
Henry T. Greely, Population participation and other factors that impact the compilation and the utility of the resulting databases, 66 La. L. Rev. 79 (2005).
Herbert Gottweis & Georg Lauss, Biobank Governance: heterogeneous mode of ordering and democratization, 3 J Community Genet 61 (2012).
H. Gottweis and K. Zatloukal, Biobank Governance: Trends and Perspectives, 74 Pathobiology 206 (2007).
Henry T. Greely, Population participation and other factors that impact the compilation and the utility of resulting databases, 66 La. L. Rev. 79 (2005).
Henry T. Greely, Breaking the stalemate: a prospective regulatory framework for unforeseen research uses of human tissue samples and health information, 34 Wake Forest L. Rev. 737 (1999).
Jane Kaye, From single biobanks to international networks: developing e-governance, 130 Hum Genet 377 (2011).
John M. Conley, Adam K. Doerr & Daniel B. Vorhaus, Enabling responsible public genomics, 20 Health Matrix 325 (2010).
Kieran C. O’Doherty, Michael M. Burgess, Kelly Edwards, Richard P. Gallagher, Alice K. Hawkins, Jane Kaye, Veronica McCaffrey & David E. Winickoff, From consent to institutions: Designing adaptative governance for genomic biobanks, 73 Social Science & Medicine 367 (2011).
Mylène Deschênes, Clémentine Sallée, Accountability in Population Biobanking: Comparative Approaches, 33 J.L. Med. & Ethics 40 (2005).
O O’Neill, Some limits of informed consent, 29 J Med Ethics 4 (2003).
Peter H.J. Riegman, Manuel M. Morente, Fay Betsou, Pasquale de Blasio, Peter Geary, the Marble Arch International Working Group on Biobanking for Biomedical Research, Biobanking for better healthcare, 2 Molecular Oncology 213 (2008).
Susan M.C. Gibbons, Regulating Biobanks: a Twelve-Point Typological Tool, 17 Med. L. Rev. 313 (2009).
Susan M. C. Gibbons and Jane Kaye, Governing genetic database: collection, storage and use, 18 Kings Law J 201 (2007).
Susan M.C. Gibbons, Jane Kaye, Andrew Smart, Catherine Heeney, Michael Parker, Governing Genetic Databases: Challenges Facing Research Regulation and Practice, 34 Journal of Law and Society 163 (2007).

B.Books
Aleksander Peczenik, Legal Doctrine as Knowledge of Law and as a Source of Law (Volume 4: Scienta Juris), in A TREATISE OF LEGAL PHILOSOPHY AND GENERAL JURISPRUDENCE ( Pattaro E. ed., 2005).
Barry R. Furrow et al., BIOETHICS: HEALTH CARE LAW AND ETHICS (6th ed. 2008).
Herbert Gottweis & Alan Peterson, Biobank and governance－an introduction, in BIOBANKS－GOVERNANCE IN COMPARATIVE PERSPECTIVES 8 (Herbert Gottweis and Alan Peterson ed., 2008).
Jane Kaye, Regulating human genetic databases in Europe, in THE ETHICS AND GOVERNANCE OF HUMAN GENETIC DATABASES 91 (Matti Hayry, Ruth Chadwick, Vilhjalmur Arnason and Gardar Arnason ed., 2007).
Julia Black, Regulation as Facilitation: Negotiating the Genetic Revolution, in LAW AND HUMAN GENETICS 29 (Roger Brownsword, W. R. Cornish, Margaret Llewelyn ed., 1998).
Karine Bedard, Susan Wallace, Stephanie Lazor & Bartha Maria Knoppers, Potential Conflicts in Governance Mechanisms used in Population Biobanks, in PRINCIPLES AND PRACTICE IN BIOBANK GOVERNANCE 217 (Jane Kaye and Mark Stranger ed., 2009).
Margaret Otlowski, Developing an Appropriate Consent Model for Biobanks: In Defense of ‘Broad’ Consent, in PRINCIPLES AND PRACTICE IN BIOBANK GOVERNANCE 79 (Jane Kaye and Mark Stranger ed., 2009).
Mark Henaghan, Bioethics and Law in Action－Miming the Gaps: The human Genome Research Project, in LAW AND BIOETHICS 225 (Michael Freeman ed., 2008).
Martin Richards, Adrienne Hunt and Graeme Laurie, UK Biobank Ethics and Governance Council: An Exercise in Added Value, in PRINCIPLES AND PRACTICE IN BIOBANK GOVERNANCE 229 (Jane Kaye and Mark Stranger ed., 2009).
Matti Hayry & Tuija Takala, American principles, European values and the mezzanine rules of ethical genetic databanking, in THE ETHICS AND GOVERNANCE OF HUMAN GENETIC DATABASES 14 ( Matti Hayry, Ruth Chadwick, Vihjalmur Arnason, Gardar Arnason ed., 2007).
OECD, Chapter 5: Data Management and Governance, in CREATION AND GOVERNANCE OF HUMAN GENETIC RESEARCH DATABASES 106 (OECD 2006)
Rainer Kattel, Genetic databases and governance, in THE ETHICS AND GOVERNANCE OF HUMAN GENETIC DATABASES 236 (Matti Hayry, Ruth Chadwick, Vihjalmur Arnason, Gardar Arnason ed., 2007).
Roger Brownsword, Bioethics: Bridging from Morality to Law?, in LAW AND BIOETHICS 17 (Michael Freeman ed., 2008).
Susan M. C. Gibbons, Governance of population genetic databases: a comparative analysis of legal regulation in Estonia, Iceland, Sweden and in the UK, in THE ETHICS AND GOVERNANCE OF HUMAN GENETIC DATABASES 132 ( Matti Hayry, Ruth Chadwick, Vihjalmur Arnason, Gardar Arnason ed., 2007).

C.Electronic Sources
European authority for supervision of pharmaceutical research (EMEA), Position paper on terminology in pharmacogenetics, Committee for Proprietary Medicinal Products (CPMP), EMEA/CPMP/3070/01 (2002), available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003889.pdf (last visited on 2012/07/25).
The National Bioethics Advisory Commission (NBAC), Ethical and Policy Issues in Research Involving Human Participants Volume I: Report and Recommendations of the National Bioethics Advisory Commission (2001), available at http://bioethics.georgetown.edu/nbac/pubs.html (last visited on 2012/07/25).
S Wallace, K Bédard and BM Knoppers, Ethics and Policymaking Core, Centre de recherche en droit public (CRDP), Université de Montréal, Building a model framework for the governance of biobanks (2008), available at P3G Observatory http://www.p3gobservatory.org/repository/ethics.htm;jsessionid=2EF7726C2AD602389AEDF187E6C1FED1 (last visited on 2012/07/25).
UK Biobank Ethics and Governance Framework, Version 3.0 (2007), available at http://www.ukbiobank.ac.uk/resources/ (last visited on 2012/07/25).

D.Websites
Website of Public Population Project in Genomics (P3G): http://www.p3g.org/secretariat/index.shtml (last visited on 2012/07/25).
Website of UK Biobank: http://www.ukbiobank.ac.uk/about-biobank-uk/ (last visited on 2012/07/25).

II.In Chinese

A.Articles
Chien-Te Fan & Chia-Cheng Liao, Commentary on the Human Biobank Management Act, 180 The Taiwan Law Review 207 (2010) (范建得、廖嘉成，人體生物資料庫管理條例評釋，月旦法學雜誌，第180期，2010年5月，頁207-219。)
Chien-Te Fan & Chia-Cheng Liao, Study on the legal and ethical framework of population-based biobank in Taiwan, 68 Taipei University Law Review 95 (2008) (范建得、廖嘉成，論建置台灣族群基因資料庫應有之法律與倫理規劃，台北大學法學論叢，第68期，2008年12月，95-149。)
Chien-Te Fan & Ju-Yin Chen, Commentary on the Taiwan Biobank Ethics and Governance Framework, 5 Taiwan Journal of Law and Technology Policy 15 (2008) (范建得、陳汝吟，台灣生物資料庫倫理治理規範評註，台灣科技法律與政策論叢，第5卷第1期，2008年6 月，頁15-45。)
Chien-Te Fan & Tsung-Hsien Liang, Addressing controversies raised on Taiwan Biobank, 91 Taiwan Law Journal 48 (2007) (范建得、梁宗憲，台灣生物資料庫爭議釋疑，台灣本土法學雜誌，第91期，2007年2月，頁48-59。)
Ching-Yi Liu, Privacy Protection in Bio-medical Technology Era, 60 Taiwan Jurist 30, 38-39 (2007) (劉靜怡，隱私權保障與生醫科技時代，月旦法學教室，2007年10月，第60期，頁30-41。)
Chung-His Lee, Study on Ethical Norms of Human Genetic Research, 141 The Taiwan Law Review47, 50-51 (2007) (李崇僖，人體基因研究之倫理規範問題初探，月旦法學雜誌，第141期，2007年2月，頁47-61。)
Chung-Lin Chen, Legal implication of informed-consent in research involving human tissue and commentary on the scope of regulation of Human Biobank Management Act, 3 Biomedicine 496, 500-501 (2010) (陳仲嶙，人體組織研究中告知後同意的法律意涵－兼論人體生物資料庫管理條例之適用範圍問題，生物醫學研究，第三卷第四期，2010年，頁496-502。)
Jui-Chu Lin & Chia-Cheng Liao, Comparative Study on Biobank Governance Framework, 27 Chung Yuan Christian University Financial and Economic Law Review 39 (2011) (林瑞珠、廖嘉成，生物資料庫治理架構之比較研究，中原財經法學，第27期，2011年12月，頁39-62。)
Jui-Chu Lin & Chia-Cheng Liao, Introduction on Taiwan Biobank important legal issues, 140 The Taiwan Law Review 169 (2007) (林瑞珠、廖嘉成，導覽Taiwan Biobank重要法律議題，月旦法學雜誌，第140期，2007年1月，頁169-179。)
Jui-Chu Lin & Tsung-Hsien Liang, Study on the Mechanism of Group Consent of Genetic Research involving Aboriginal People, 5 Taiwan Journal of Law and Technology Policy 87 (2008) (林瑞珠，梁宗憲，論我國原住民族群基因研究之群體同意機制，台灣科技法律與政策論叢，第五卷第一期，2008年6月，頁87-118。)
Shang-Yung Yen, Commentary on the draft version of Human Biobank Management Act, 168 The Taiwan Law Review 155, 168-169 (2009) (顏上詠，台灣人體生物料庫管理條例草案評析，月旦法學雜誌，第168期，2009年5月，頁155-171。)
Ting-Feng Wu, Yu-Feng Wong, Chia-Hsin Chen, Public trust of Biobank: learning from Taiwan Biobank experience, Paper presented at the National Kaoshiung Marine University Annual STS conference (2010) (吳挺鋒、翁裕峯、陳佳欣，人體生物資料庫的公眾溝通：台灣經驗的初探，發表於國立高雄海洋科技大學STS年會（2010年5月15-16日）。

B.Book
Chien-Te Fan, Jui-Chu Lin, Chung-His Lee, Ju-Yin Chen, Chung-Lin Chen et al., COMMENTARIES ON THE HUMAN BIOBANK MANAGEMENT ACT 13 (1st ed. 2010) (范建得、林瑞珠、李崇僖、陳汝吟、陳仲嶙等合著，人體生物資料庫管理條例逐條釋義，清華大學生物倫理與法律中心，2010年12月初版。)

C.Electronic Sources
Legislative Yuan, Explanatory Note on the draft version of Human Biobank Management Act, Legislative material from the 7th Legislative Yuan 4th Session 12th Meeting (2009) (人體生物資料庫管理條例草案總說明，立法院第7屆第4會期第12次會議議案關係文書，98年12月2日), available at http://lis.ly.gov.tw/lghtml/lawstat/prochtml/0253899010700.htm (last visited on 2012/07/25).
Taiwan Biobank, Report on ELSI Training of Taiwan Biobank Pilot Research Project (2008) (建置台灣生物資料庫先期規劃－ELSI教育訓練討論摘記，2008年3月10日), available at www.twbiobank.org.tw/Doc/03Event/11-23-M.pdf (last visited on 2012/07/25).

D.Websites
Website of Taiwan Biobank: http://www.twbiobank.org.tw/ (last visited on 2012/ 07/25).