Minssen Timo, Schovsbo Jens
Centre for Information & Innovation Law (CIIR), University of Copenhagen, Faculty of Law, Studiegården, Studiestræde 6, 1455 Copenhagen, Denmark.
Per Med. 2014 Jul;11(5):497-508. doi: 10.2217/pme.14.29.
This perspective article provides an overview on selected legal aspects of biobanking. It discusses these issues with a focus on public biobanks in a university setting and the specific challenges posed by personalized medicine. We conclude that any decisions as to the design of the regulatory environment should follow a process that takes account of the values, hopes and concerns of all stakeholders involved. In particular, we stress the importance of a careful planning of consent obligations combining traditional legal methods with an adequate institutional setup. In order to enhance the translational exploitation of biobanks, we further emphasize the pressing need to carefully consider a great variety of strategies and policy choices relating to intellectual property rights.
这篇观点文章概述了生物样本库在特定法律方面的情况。文章讨论这些问题时，重点关注大学环境中的公共生物样本库以及个性化医疗带来的特殊挑战。我们得出结论，关于监管环境设计的任何决策都应遵循一个考虑到所有相关利益攸关方的价值观、希望和关切的过程。特别是，我们强调精心规划同意义务的重要性，将传统法律方法与适当的机构设置相结合。为了加强生物样本库的转化利用，我们进一步强调迫切需要仔细考虑与知识产权相关的各种策略和政策选择。
