出版社：AHRC Research Centre for Studies in Intellectual Property and Technology Law
摘要：Biobanks are essential tools for genetic research, particularly genome-wide association studies (GWAS) and for the pharmaceutical industry for the translation of research findings into new products. Biobanks will also serve in the development of personalised medicine (The Royal Society, Personalised Medicine: Hopes and Realities (2005)). Jeroboams of printing ink have been devoted to the ethical, regulatory and social challenges associated with biobanks, particularly in relation to consent and privacy. Some scholars argue that the traditional consent model is simply too outdated for the genome era of high throughput genetic profiling and analysis, where entire populations can be genotyped in a matter of days and, future undefined research may be undertaken. There has been a focus shift to “governance” approaches to the administration, management, custodianship and security of biobanks. The establishment of increasing numbers of biobanks around the world has led to a rush of policy statements (NCI, First-Generation Guidelines for NCI-Supported BioRepositories (Washington DCL National Cancer Institute, National Institutes of Health, US Department of Health and Human Services, 2006) and academic commentary debating the nature, form and content of the instruments needed to regulate this activity. In addition, some large-scale biobanks have developed their own governance frameworks (for example, UK Biobank. Ethics and Governance Framework, Version 2).
