The Biobank Act as a Route to Responsible Research: A First Step for Taiwan?

Abstract

In recent years, biobanks have been established around the world to monitor the health status of participants over time, to assess the natural occurrence and progression of common diseases.1 Therefore, it is not surprising to learn that traditional ethical and legal issues such as informed consent, privacy protection, data security, nondiscrimination, autonomy and self-determination have occupied a central place in the regulatory debates on biobanks.2 In the midst of controversies raised by human rights organizations and aboriginal rights groups,3 Taiwan’s Human Biobank Management Act (“the Act”) was passed by the Legislative Yuan on January 7, 2010 and came into effect on February 3 in the same year. While the Act addresses the absence of biobank regulations, it could also have a marked impact upon local biomedical research communities. It is therefore necessary to address the coverage of the Act, which is one of the key issues surrounding this legislation. The Act was originally designed to regulate the establishment and management of biobanks; mainly, the collection and storage of human biological samples and associated data. According to Article 3(4), a regulated biobank that contains biological specimens from human subjects, along with related information and data, should also have the following two characteristics: (1) it should provide for biometrics-related research, which is populationor specific-group-based; and (2) it should be maintained with linkable data. In other words, in addition to the regulation of biobanking, the Act also regulates biomedical research activities that originate from the use of biological specimens and data from biobanks. Biomedical research that does not use biological specimens or data from biobanks is not covered by the Act. Any specific research in which biological specimens and associated data are collected and then destroyed or delinked upon completion of the research is not deemed to be a biobanking project. On the contrary, archive collections without a defined research purpose are targets of the Act. This includes collections that have biological specimens and data collected for a general, undefined purpose other than immediate research use, as well as those maintained by many university laboratories from earlier studies. Among other things, it is worthwhile to note that Article 29 does give rise to a question regarding