Linkages: Translational Medicine, Repository & Inter-CEER Activities

Linkage Core将设在杜克大学IGSP基因组伦理、法律和政策中心，由备受尊敬的国家专家Laura Beskow博士和Geoff Ginsburg博士指导，并与其他核心和项目的研究人员合作。我们在过去五年中使用CpG 1.0的经验表明，临床翻译科学奖(CTSA)网站、其他CEER以及基因组学研究中的国家(NIH和其他)重大倡议正在努力解决与CpG 2.0重点相关的许多问题，如数据和材料的共享、知识产权(IP)、作者身份、出版物访问等。此外，我们发现，与基因组研究有关的基本ELSI问题，例如适当收集生物标本、对基因组信息共享的知情同意以及与研究人群的利益分享，虽然不是CpG的中心重点，但仍是其许多项目的基础，这些领域的专门知识至关重要。因此，这个核心将为跨CEER活动、CTSA和其他主要基因组计划提供关键的联系，将提供有关ELSI相关问题的专业知识，并将使Beskow博士和Ginsburg博士以及CpG的其他研究人员能够参与国家ELSI活动。 在CpG的头五年里，研究人员多次被邀请参与将该CEER与其他CEER联系起来的项目，以及其他主要倡议，例如努力为全基因组关联研究(GWAS)、生物库讨论和电子医疗记录和基因组学网络(Emerge)制定适当的数据共享政策。其他例子包括研究中的保密问题和个性化医学：一名杜克大学的研究人员联系我们中心，因为她为一个大型、多机构、长期项目获得的保密证书 在法庭上受到质疑。她想知道基因分型对未来研究的影响，这导致Beskow和Dame进行了研究，并在《科学》上发表了一篇政策论坛文章。金斯伯格博士参加了2008年10月的个性化医学峰会，该峰会主要关注翻译基因组学，并发表了一篇关于学术中心在个性化医学中的作用的论文--这是金斯伯格、库克-迪根和IGSP常驻企业家贾德·斯台普斯合作的结果。 CPG需要一种机制来参与与其他CEER、CTSA中心以及重大的多机构倡议的国家讨论；CPG 1.0最初的一个缺陷就是缺乏这样的机制。这一核心是对我们的经验的回应，即我们将多次被邀请参加不以知识产权为中心的讨论，但确实涉及法律、数据共享和其他与CpG的专业知识相关的问题。

The Linkage Core will be housed in Duke's IGSP Center for Genome Ethics, Law & Policy, and directed by Drs. Laura Beskow and Geoff Ginsburg, highly respected national experts, in collaboration with investigators in other cores and Projects. Our experience during the past five years with CpG 1.0 suggests that Clinical Translational Science Award (CTSA) sites, other CEERs, and major national (NIH and other) initiatives in genomics research are grappling with many issues that are related to the focus of CpG 2.0, such as sharing of data and materials, intellectual property (IP), authorship, publication access, and others. In addition, we found that fundamental ELSI concerns related to genomic research¿for example, the appropriate collecting of biospecimens, informed consent for genomic information-sharing, and benefits-sharing with research populations¿while not the central focus of the CpG, nevertheless underlie many of its projects, and expertise in these areas is vital. Thus, this Core will provide a crucial link to trans-CEER activities, CTSAs, and other major genomic initiatives, will provide expertise on underling ELSI issues, and will enable Drs. Beskow and Ginsburg, as well as other CpG investigators, to participate in national ELSI activities. During the CpG's first five years, investigators were repeatedly invited to participate in projects that would link this CEER to other CEERs, as well as to other major initiatives, such as the effort to develop appropriate data-sharing policies for genome-wide association studies (GWAS), biorepository discussions, and the Electronic Medical Records & Genomics Network (eMERGE). Other examples include issues of confidentiality in research, and personalized medicine: one Duke researcher contacted our Center because the Certificate of Confidentiality she had obtained for a large, multi-institutional, long-term project had been challenged in court. She wondered about the implications for future research related to genotyping, and that led Beskow and Dame to do research and publish a Policy Forum article in Science.[143] As another example. Dr. Ginsburg attended a Personalized Medicine Summit in October 2008 that focused mainly on translational genomics, and presented a paper on the role of academic centers in personalized medicine¿the result of a collaboration between Ginsburg, Cook-Deegan, and Judd Staples, IGSP's entrepreneur-in-residence.[144] CpG needs a mechanism to participate in national discussions with other CEERs, CTSA centers, and major, multi-institution initiatives; the lack of such a mechanism was an initial flaw in CpG 1.0. This core is a response to our experience that we will be repeatedly invited into discussions that are not centered on intellectual property, but do bear on law, data-sharing, and other matters where CpG expertise is relevant.