Linkages: Translational Medicine, Repository & Inter-CEER Activities

链接核心将被安置在杜克大学基因组伦理，法律和政策IGSP中心，并由博士指导。劳拉·贝斯科和杰夫·金斯伯格，备受尊敬的国家专家，与其他核心和项目的研究人员合作。我们在过去五年CpG 1.0的经验表明，临床转化科学奖（CTSA）网站、其他ceer和基因组学研究的主要国家（NIH和其他）计划正在努力解决与CpG 2.0的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相关的基本ELSI问题-例如，适当收集生物标本，基因组信息共享的知情同意以及与研究人群的利益共享-虽然不是CpG的中心焦点，但却是其许多项目的基础，并且这些领域的专业知识至关重要。因此，该核心将为跨ceer活动、CTSAs和其他主要基因组计划提供关键联系，将为基础的ELSI问题提供专业知识，并将使博士能够。Beskow和Ginsburg，以及其他CpG研究者，参加国家ELSI活动。

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.