Suchergebnisse

The post-genomic era is witnessing a proliferation of large-scale and population based genetic and genomic research projects. Many countries have or are establishing research biobanks and, as with GenomEUtwin, there is great interest in building multinational projects that link genotypic and phenotypic information from different centers. Clearly, the conduct of these projects raises multiple ethical issues, and the knowledge generated will continually recast the ethical, legal and social implications (ELSI) of such research. Maximising the scientific profit from this work while minimizing the risks to the participants requires full integration of ethics components into the structure and functioning of these projects. GenomEUtwin is organized around five intellectual cores, including an Ethics Core which operates across the entire project. This paper describes the role of the Ethics Core and presents an overview of the guidelines on which the principles followed in GenomEUtwin are based. We outline the major ethical concerns of our project and highlight complexities arising from diverse national legislations. Finally, the role of empirically based ethics research is discussed for understanding the ethical, legal, social and economic implications of human genetics and genomics research.

Bioscience has recently undergone a series of knowledge-based and technological revolutions. A critical consequence has been increasing recognition of the need to invest in infrastructure. Good access to data (and samples) from multiple studies is axiomatic to the value of this infrastructure. Access must be streamlined, secure, and based upon transparent and 'fair' decision making. It must be clear who has created and who has used which data. Ethico-legal policies and guidelines, which reflect dominant local cultural and societal norms, must take account of the increasingly global nature of bioscience research. A robust data infrastructure must also be attentive to the translational aims and social impact of its knowledge generation. In order to maintain the trust of its constituency – the general public as well as professional, political, commercial stakeholders – it must develop mechanisms to take account of all of these perspectives. These considerations form the basis of an emerging data economy. Building on extant achievements and pursuing the ideas outlined here could revolutionise the way we use and manage large-scale data. They have critical implications for biomedical and public health research communities and will be of central relevance for healthcare managers and policy makers, governments and industry. However, if the major challenges are to be met we must continue to invest,both nationally and internationally, in developing the cooperative infrastructures that provide a complementary foil to competitive resourcing mechanisms that drive hypothesis-driven science.