title: Impact of development of population-based study in biomedical field on laws and regulations: a cross-strait experience on biobank development.
abstract: Together with the completion of the Human Genome Project, biomedical research has marched into the "Post-Genomic Era." In order to take advantage of these extracted gene related information extensively and precisely so as to realize the human being's biological phenomena as well as the mechanism of pathogenesis, consequentially, large scale sample collection of different geological areas and/or ethic group becomes necessary for the future population based genetic research of a country and, in turn, the construction of population-based genetic database (Biobank). In recent years, both mainland China & Taiwan have not only made great progress in information & computation technologies but have also gradually taken a close look into the quality of medicine delivery. Thus, it becomes unavoidable for both sides to create each one's population-based genetic databases (Biobank). Theoretically speaking, the Biobank development shall benefit the study on the correlation between genes and disease and, also, the solution for disease treatment. At the same time, medical diagnosis technology has also been significantly improved. It is believable that the population-based genetic database might be utilized to promote medical quality and to reduce the cost of public health delivery. Furthermore, in the near future, it might become the "raw materials" for medical research application. However, when taking the public welfare promotion as the premises for a Biobank development, severe and multi challenges occurred against traditional legal rules in terms of the privacy protection, public trust development, the compliance of informed consent principle, the implementation of a benefit-sharing doctrine and the possible discrimination concern on the population/participants selection and some other ELSI issues. In this paper, the major legal issues encountered by the Biobank development will be firstly reviewed accompanied with the background information concerning the Biobank development scenario crossing the Taiwan Strait. Also, mainly following the realm of comparative policy or legal approaches, the paper, learning from the fruits of this comparative study, tries to propose some recommendations for future legislative consideration by both mainland China & Taiwan. It's been this author's wish that, when establishing a large scale population based Biobank, the promotion of public trust shall be placed as the primary goal together with the emphasis on the supporting publicity and transparency on the administrative practices, so as to encourage the public participation in observing the principle of altruism and, in turns, benefit the future biomedicine development.
authors.affiliation: Institute of Science and Technology Law, National Tsing-hua University, China. fanct@ms31.hinet.net
authors.forename: Chien Te
authors.initials: CT
authors.lastname: Fan
authors.forename: Chunyan
authors.initials: C
authors.lastname: Wu
authors.forename: Zhiyuan
authors.initials: Z
authors.lastname: Shi
mesh_terms: D000533:Altruism; D002681:China; D030541:Databases, Genetic / Q000331:legislation & jurisprudence*; D030561:Databases, Nucleic Acid; D005544:Forecasting; D030661:Genetic Privacy; D005828:Genetics, Population / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent; D011641:Public Relations; D013624:Taiwan