title: Taiwan Regulation of Biobanks.
abstract: This paper introduces legal framework and governance structure in relation to the management and development of biobanks in Taiwan. At first, we briefly describe Taiwan's population, political system and health care system. Secondly, this research introduces biobanking framework of Taiwan including 25 biobanks established with the approval of the Ministry of Health and Welfare. In those biobanks, "Taiwan Biobank" is the first and the largest government-supported biobank which comprises population-based cohort study and disease- oriented study. Since the collection of information, data, and biological specimen of biobanks often involve highly sensitive personal information, in the legal framework of Taiwan, there is a specific regulation, "Human Biobank Management Act" (HBMA), which plays an important role in regulating biobanks in Taiwan. HBMA, the Personal Information Act and other regulations constitute a comprehensive legal and regulatory privacy framework of biobanks. Through the introduction and analysis of the current legal framework applicable to biobanks, we found that there are several challenges that need to be solved appropriately that involve duplicate review systems, the obstacles in the international collaboration, and data sharing between biobanks in Taiwan.
authors.affiliation: Received his LL.B. degree from Soochow University, LL.M. degree from University of Washington and J.D. Degree from Puget Sound University. He is is a Professor and Director at the Institute of Law for Science & Technology at National Tsing Hua University in Taiwan.
authors.forename: Chien-Te
authors.initials: CT
authors.lastname: Fan
authors.affiliation: Received a B.S. degree from National Tsing-Hua University, M.S. degree from National Tsing-Hua University and LL.M. degree from National Tsing-Hua Universtiy. He is an Attorney-at-Law and a Research Assistant at the Institute of Law for Science & Technology at National Tsing Hua University in Taiwan.
authors.forename: Tzu-Hsun
authors.initials: TH
authors.lastname: Hung
authors.affiliation: Received a B.S. degree from National Taiwan University. He is a Research Assistant at the Institute of Law for Science & Technology at National Tsing Hua University in Taiwan.
authors.forename: Chan-Kun
authors.initials: CK
authors.lastname: Yeh
mesh_terms: D022126:Access to Information / Q000331:legislation & jurisprudence; D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D035843:Biomedical Research / Q000331:legislation & jurisprudence; D003219:Confidentiality / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D013624:Taiwan