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.

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