The Legalisation of Ethical Governance in Taiwan Biobank Development

Introduction

The term “biobank” is in fact a heterogeneous concept including a wide range of human biological samples, DNA and other genetic sample collections that can be classified according to different criteria,¹ with population-based biobanks as one of them. On the international level, important initiatives concerning the establishment of population-based biobanks are developing in several countries. Taiwan also intends to create such a biobank (Taiwan Biobank) with local features. Supporting this initiative, the corresponding legislation, Human Genetic Database Management Act (hereinafter referred to as “Taiwan Biobank Act”) was approved on 7 January 2010. In this article, we will focus narrowly on population-based biobanks, going through the major ethical issues involved that should enable a trustworthy foundation of a biobank. Then departing from these ethical issues, the current legislation in Taiwan (especially the Taiwan Biobank Act) will be introduced and analysed to explore how the corresponding regulations could respond to the ethical issues.

With the advancement in the understanding of genetics, new methods have been developed to explore genetic materials in order to identify gene variations associated with disease. However, mechanisms underlying common diseases may not only be determined by a single gene, but the combination of several genes along with environmental factors. We can therefore understand that research on these types of diseases requires a variety of resources, including genetic material, medical records and lifestyle information. To support biomedical research, biobanks were established in several countries; for instance, the deCODE genetics biobank in Iceland and the UK Biobank which both collect biospecimens containing genetic material. Due to medical advances, the population structure in Taiwan is ageing as the average life expectancy increases. In this context, health enhancement and disease prevention become increasingly important issues in the public health field. Therefore, identifying risk factors of common diseases in order to alter health-related behaviour can contribute to improve health and prevent disease. Based on the above objectives, The Taiwan Biobank intends to conduct large-scale cohort research for a long period of time, using the combination of genetic and other medical information. The establishment of the Taiwan Biobank can thus contribute to the understanding of the mechanism underlying common diseases in Taiwan, to the improvement of medical treatment or prevention strategy, and to the reduction of medical cost, all to reach the goal of improved health for the population. Taiwan’s biobank went through pilot and feasibility projects, with the underlying legislation, the Biobank Act, approved on 7 January 2010.

In this article, we intend to focus on the population-based biobank, thus the term “biobank” is here narrowly defined. It can be distinguished from other types of biobanks through its purpose and its scale: it has a generalised purpose that is the investigation of gene-environment-lifestyle interaction in multifactorial disease, and it requires a large participant population collecting large amounts of samples. However, if broadly defined, the term “biobank” also includes disease-oriented tumour banks,² collection of non-human biological samples, simple collection of DNA sequences, etc., intended for research or for other purposes such as criminal investigations.

In sum, the characteristics of a biobank could be understood from the perspective of research on multi-factorial diseases. For the results to be relevant, large-scale, population-based and long-term studies should be conducted. Biospecimens, stored in the biobank, are collected from a large sample with the collection of biospecimens repeated. We should notice that the collection of samples (for instance, blood, urine, sperm, etc) are not always necessary in the medical context: it could be the collection is intended for a cohort study of a specific disease, or it could be the collection is from healthy people for a population-based study. Samples collected for future use containing genetic information have a specific status. As stated in the International Declaration on Human Genetic Data:

Human genetic data have a special status because: (i) they can be predictive of genetic predispositions concerning individuals; (ii) they may have a significant impact on the family, including offspring, extending over generations, and in some instances on...