Biobank research in the age of genomics. From public health to personalized medicine

Genome sequencing has revolutionized biomedical science, providing hope for a more presise and preventative "personalized medicine". Genomics research in population-based biobanks, such as the Nord-Trøndelag HUNT biobank, provides a crucial part of this development. One of the key topics in the process of designing the fourth HUNT study, which is planned for 2017, is how to ensure a trustworthy use of the biological material and data while at the same time accommodate potential vital research based on this very rich research resource. Central questions in the ethical debate on biobanking include how to secure valid and relevant consent, how to protect participants in genomics data sharing in research collaboration, and what kind of health related results should be shared with biobank participants. The aim of the network project Biobank research in the age of genomics. From public health to personalized medicine led by the RESET research group, is to examine the development of genomics-based medicine through the case of population-based biobank research, analyzing the cultural prerequisites of biobank research as they are played out in the ethics debate. The ethical issues of consent, return of health information and the protection of privacy in international data sharing were discussed in a series of three international workshops, combined with open public meetings. The aim was to contribute to the general debate on the cultural basis for a socially robust biobank practice in general and to the ethics of genomics in biobanking in particular, and to give direct input to the setup of the HUNT4 study. The first workshop, on consent, was arranged in September 2015, and attracted a wide group of approximately 40 participants, mainly from the HUNT biobank, research ethics committee, and bioethicists. Jane Kaye, Oxford, who has led the development of dynamic consent solutions for biobank research, were among the invited speakers. Another speaker, Neil Manson, also spoke on a public meeting in Trondheim after the workshop, arranged in cooperation with NTNU?s Theory of Science Forum. Prior to the workshop, we arranged an open meeting in Levanger in order to learn how the HUNT participants and other lay people from the area consider the consent issue in biobank research, with 45 people attending. The second workshop was arranged in June 2016, and was combined with a workshop in the RCN-funded project Crossover Research 2. The topic was protecting citizens' privacy versus visions of improved medicine for the common good. The two workshops were complementary and partly drew on the same local and international expertise. There were approximately 25 participants from ethics, philosophy of science, informatics and biotechnology, and the issue was explored as a combined technical and ethical challenge. We had international and local speakers discussing the topics from their respective theoretical and practical perspectives. In conjunction with the workshop, we arranged a public lecture on the ethics of technology with the invited participant Carl Mitcham, Beijing in collaboration with the Theory of Science Forum. Other speakers were Tsjalling Swierstra, Maastricht, and Erik Fisher, Arizona. The final workshop on return of results was arranged in Trondheim, September 2017 with Timothy Caulfield, Alberta and Nina Hallowell, Oxford as main speakers together with speakers from Belgium, the Netherlands, HUNT and the RESET group. The discussion demonstrated the significance of cultural preconditions for concrete ethical and political to these issues and the value of empirical research for pricipled questions in applied ethics. There were approximately 25 participants at the workshop, which was held the week the HUNT4 study started. Prior to the workshop was an open public meeting arranged together with the Norwegian Biotechnology Advisory Board, with Caulfield and Hallowell as main speakers for an audience of approximately 80 people. The project has shown that analyzing cultural preconditions is essential for understanding techno-moral change in society, and that we need to understand them in order to find sustainable solutions to the question of how to use private information in genomics-based health research. The project has strengthened existing research collaboration and has established new ones that will be relevant for future applications for research funding within this research field.

Genomic sequencing has revolutionized biomedical science, providing hope for a more precise and preventative "personalized medicine". Genomics research in population-based biobanks, such as the Nord-Trøndelag HUNT biobank, provides a crucial part of this development. One of the key topics in the process of designing the fourth HUNT study, which is planned for 2017, is how to ensure a trustworthy use of the biological material and data while at the same time accommodate potential vital research based on this very rich research resource. Our aim in this proposal is to contribute to the exploration of the "technological environment" of the development of genomics-based medicine through the case of population-based biobank research, analyzing the cultural prerequisites of biobank research as they are played out in the ethics debate. The general assumption is that the Norwegian public health model is of significance for the public's motivation for participation and for the handling of central ethical issues in biobanking. However, we encounter several challenges when the focus shifts towards personalized medicine in general and individual access and use of genomic information in particular. We want to explore the ethical issues of consent, return of health information and the protection of privacy in international data sharing in a series of three international workshops, combined with seminars with our local researchers and open public meetings. This will not only contribute to the general debate on the cultural basis for a socially robust biobank practice in general and on the ethics of genomics in biobanking in particular, but provide direct input to the setup of the HUNT4 study. It will also provide basis for future research projects on these topics.