The Legalisation of Ethical Governance in Taiwan Biobank Development

Abstract

"After more than 6 years in effort, Taiwan Biobank development has found its first morning light. In the early 2010, the critical legislation of Human Genetic Data Protection Act (HGDPA) was passed in Legislative Yuan of Taiwan. It’s been the major break-through since Taiwan government started her daring move to pursue a large scale population-based genetic data based development in 2004. The project was part of Taiwan’s national research program to promote Taiwan as “An Island of Biomedicine.” In past 6 years, the project was firstly kicked off by a Feasibility Study, next by a four-year term Pilot Study. Now, the year 2010 will be the end of said Pilot Study. Hopefully, the real Biobank development will be initiated soon subject to the provisions of HGDPA. Learning from this long period of research efforts, variable ethical concerns are in issues. Now, Taiwan has turned all her experiences into the legislation. In other words, the future Taiwan Biobank development shall be governed by the HGDPA & Ethics Governance Rules promulgated according to the Act. In this article, the main ethical concerns regarding informed consent, ethical governance & utilization of the database are highlighted so as to exemplify Taiwan’s policy in consolidating the ethical foundation of biobanking through the legislative efforts. Hopefully, the legal rules may lay down a solid platform of public trust to facilitate the further development of Taiwan Biobank"