《欧洲通用数据保护条例》：诱导多能干细胞研究人员和生物样本库面临的挑战与考量
The European General Data Protection Regulation: challenges and considerations for iPSC researchers and biobanks.
作者信息
Morrison Michael, Bell Jessica, George Carol, Harmon Shawn, Munsie Megan, Kaye Jane
机构信息
Nuffield Department of Population Health, HeLEX - Center for Health, Law & Emerging Technologies, University of Oxford, Ewert House, Ewert Place, Banbury Road, Oxford OX2 7DD, UK.
Melbourne Law School, University of Melbourne, Parkville, VIC 3010, Australia.
出版信息
Regen Med. 2017 Sep;12(6):693-703. doi: 10.2217/rme-2017-0068. Epub 2017 Oct 4.
Abstract
Increasingly, human induced pluripotent stem cells (iPSC) and their associated genetic and clinical information are being used in a wide range of applications, with large biobanks being established to support and increase their scientific use. The new European General Data Protection Regulations, which comes into effect in 2018, will have implications for biobanks that generate, store and allow research access to iPSC. This paper describes some of the challenges that iPSC biobanks face and suggests some points for the development of appropriate governance structures to address these new requirements. These suggestions also have implications for iPSC research in general.
摘要
人类诱导多能干细胞（iPSC）及其相关的基因和临床信息越来越多地被用于广泛的应用中，大型生物样本库也在不断建立，以支持并增加其科学应用。2018年生效的新的欧洲通用数据保护条例，将对生成、存储并允许研究人员获取iPSC的生物样本库产生影响。本文描述了iPSC生物样本库面临的一些挑战，并就如何建立适当的治理结构以满足这些新要求提出了一些建议。这些建议对一般的iPSC研究也具有启示意义。
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