restricted access An Empirical Survey on Ethical Governance Practices in the Pilot Study of Taiwan Biobank
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An Empirical Survey on Ethical Governance Practices in the Pilot Study of Taiwan Biobank

Introduction

Benefiting from the advance of biomedical technology, researchers nowadays can access a wider range of medical knowledge, and have a deeper insight into the cause of disease. Moreover, it is commonly held that there is complicated interplay among genes, environment and diseases, and that if we can have better understanding about these connections, we will be able to have a better grip in preventing the occurrence of diseases. 1 However, biomedical research relies on human tissues as research materials, and have brought about not only technological advances, but also ethical, legal, and social issues (ELSIs) to the research community and beyond.

As noted in the literature on ethics and governance of biobanks, the most debated question is whether existing ethical and legal frameworks are sufficient to mediate between competing interests involved in biobank initiatives. 2 In order to develop more appropriate protection of research participants, bio-ethicists have articulated respect for human dignity, justice and beneficence as the fundamental ethical principles, with informed consent and the institutional review board as the mechanism to implement them. 3 As concerns over biobank governance grow, public attention that ELSIs attract has been more significant than ever. 4 These questions and issues have also been addressed during the Pilot Study of Taiwan Biobank.

To decipher the connection between environment, genes and disease, establishing large-scale biobanks becomes an appealing approach. Because researchers [End Page 216] will be able to access large amounts of disease records, medical information and human tissues, and through cross-examination of these data, researchers can understand the cause of disease more accurately than before. As a result, more and more countries made great efforts in establishing their population-based biobanks. In the race for technological and industrial advantages, the biobank is a country's key to the success of biomedical technology policies.

With its unique population structure and well-developed household registration system, together with National Health Insurance that covers almost all of its citizens and permanent residents, Taiwan has the potential of becoming the centre of biomedical technology in the Chinese-speaking world. In order to facilitate its plan for a "biomedical island", Taiwan initiated its plan to establish a national biobank, 5 and has successfully completed the Feasibility Study in 2007. 6 Following the completion of the Feasibility Study, a Pilot Study was launched in 2007, wherein about 15,000 participants were expected to join the pilot project. By launching the Pilot Study, the Taiwanese Government aimed at clarifying the potential issues in building a national biobank, and at establishing a platform to communicate with the general public. 7 To date, approximately 7,000 participants have joined the Pilot Study.

However, the establishment of a biobank may involve legal as well as ethical issues including the right to self-determination, the right to privacy, the right to equality, access to the data and information, benefit-sharing, and aboriginal rights. Appropriate handling of these ELSIs is essential to win public support for the continuation of the taxpayer-funded project, which is at the heart of Taiwan's future in the biomedical industry. In this article, the authors, summarising from a report conducted by an independent review task in late 2009, intend to discuss issues that the Pilot Study has encountered and to address questions regarding the governance of the Taiwan Biobank project. In short, ELSI-related issues concerning the Pilot Study of Taiwan Biobank and the governance framework of the project will be reviewed in this article so as to present the authors' opinions and recommendations in these regards.

The Pilot Study of Taiwan Biobank

An Overview of the Pilot Study

With its ageing population, Taiwan has marked chronic diseases as the greatest threat to human health, letting behind epidemic diseases. Since chronic diseases are largely connected with the genetic features of a certain population, population-based research is believed to be useful in finding solutions for chronic diseases. The idea of establishing a national human biological database, [End Page 217] therefore, was adopted by the Taiwanese government in a bid...


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