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.

Agency
National Institute of Health (NIH)
Institute
National Human Genome Research Institute (NHGRI)
Type
Specialized Center (P50)
Project #
2P50HG003391-06
Application #
8125708
Study Section
Special Emphasis Panel (ZHG1-HGR-P (J1))
Project Start
Project End
Budget Start
2011-04-15
Budget End
2012-03-31
Support Year
6
Fiscal Year
2011
Total Cost
$27,100
Indirect Cost
Name
Duke University
Department
Type
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Cook-Deegan, Robert; Ankeny, Rachel A; Maxson Jones, Kathryn (2017) Sharing Data to Build a Medical Information Commons: From Bermuda to the Global Alliance. Annu Rev Genomics Hum Genet 18:389-415
Cook-Deegan, Robert; McGuire, Amy L (2017) Moving beyond Bermuda: sharing data to build a medical information commons. Genome Res 27:897-901
Thorogood, Adrian; Cook-Deegan, Robert; Knoppers, Bartha Maria (2017) Public variant databases: liability? Genet Med 19:838-841
Cook-Deegan, Robert; Vishnubhakat, Saurabh; Bubela, Tania (2016) The mouse that trolled (again). J Law Biosci 3:185-191
Michie, Marsha; Kraft, Stephanie A; Minear, Mollie A et al. (2016) Informed decision-making about prenatal cfDNA screening: An assessment of written materials. Ethics Med Public Health 2:362-371
Meredith, Stephanie; Kaposy, Christopher; Miller, Victoria J et al. (2016) Impact of the increased adoption of prenatal cfDNA screening on non-profit patient advocacy organizations in the United States. Prenat Diagn 36:714-9
Bubela, Tania; Vishnubhakat, Saurabh; Cook-Deegan, Robert (2015) The Mouse That Trolled: The Long and Tortuous History of a Gene Mutation Patent That Became an Expensive Impediment to Alzheimer's Research. J Law Biosci 2:213-262
Angrist, M; Jamal, L (2015) Living laboratory: whole-genome sequencing as a learning healthcare enterprise. Clin Genet 87:311-8
Contreras, Jorge L; Rai, Arti K; Torrance, Andrew W (2015) Intellectual property issues and synthetic biology standards. Nat Biotechnol 33:24-5
Fernandez, Conrad V; O'Rourke, P Pearl; Beskow, Laura M (2015) Canadian Research Ethics Board Leadership Attitudes to the Return of Genetic Research Results to Individuals and Their Families. J Law Med Ethics 43:514-22

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