UID:
edoccha_9960982377402883
Format:
1 online resource (232 pages)
ISBN:
0-12-819804-4
Note:
Front cover -- Half title -- Title -- Copyright -- Contents -- Contributors -- 1 Introduction to the volume -- Acknowledgments -- References -- 2 From public resources to improving health: How genomic data sharing empowers science and medicine -- 2.1 Introduction -- 2.2 The Human Genome Project set the paradigm for genomic data sharing -- 2.3 Genomic data sharing enables multiple areas of research -- Ethical/moral -- Scientific/practical -- 2.3.1 Research using model organisms -- 2.3.2 Research using human data -- 2.3.3 Technical analysis development -- 2.4 Putting data sharing into practice -- 2.5 Data sharing will propel precision medicine -- 2.6 Learning healthcare systems and data sharing -- 2.7 Need for responsible data stewardship -- 2.8 Barriers to genomic data sharing -- 2.9 Conclusion -- References -- 3 Biobank case example: Marshfield clinic -- 3.1 Stakeholder engagement -- 3.1.1 External stakeholders -- 3.1.2 Internal stakeholders -- 3.2 Technical procedures to facilitate genomic data sharing with collaborators -- 3.3 Phase 1-Sample identification, phenotyping, and quality controls -- 3.3.1 Phenotype data quality controls -- 3.3.2 Sample data quality controls -- 3.4 Phase 2-Data integration and sample return -- 3.5 Phase 3-Finalizing datasets -- 3.6 Phase 4-Data access -- 3.6.1 Pilot genomic data sharing projects with participants -- 3.7 Summary -- References -- 4 Multidirectional genetic and genomic data sharing in the All of Us research program -- 4.1 Introduction -- 4.2 Sharing data with researchers -- 4.2.1 Relevant considerations -- 4.2.2 Guiding concepts for sharing data with researchers -- 4.2.3 Implementation -- 4.2.4 Lessons learned and future directions -- 4.3 Returning genetic and genomic results to participants -- 4.3.1 Relevant considerations -- 4.3.2 Guiding concepts for the return of genetic and genomic results.
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4.3.3 Implementation -- 4.3.4 Lessons learned and future directions -- 4.4 Concluding remarks -- References -- 5 A community approach to standards development: The Global Alliance for Genomics and Health (GA4GH) -- 5.1 Introduction -- 5.2 The rationale for and promise of an international alliance (2012-2014) -- 5.3 Convening the community (2014-2017) -- 5.4 GA4GH connect (2017-2019) -- 5.5 Gap analysis (2019-2021) -- 5.5.1 Technical alignment -- 5.5.2 Implementation support -- 5.5.3 Clinical engagement -- 5.6 Beyond GA4GH connect (2021 and beyond) -- 5.7 A novel approach to funding and support -- 5.8 Three recommendations -- 5.8.1 Community needs should drive development -- 5.8.2 Create global equity and opportunity to ensure fit-for-purpose development -- 5.8.3 Strive for consensus and intentional decision-making -- 5.9 Conclusion -- Acknowledgments -- References -- 6 Clinical genomic data on FHIR®: Case studies in the development and adoption of the Genomics Reporting Implementation Guide -- 6.1 Background -- 6.1.1 Health Level 7 (HL7) -- 6.1.2 HL7 Clinical Genomics -- 6.2 Case studies: implementation of HL7 FHIR -- 6.2.1 Exchanging HLA data for histocompatibility and immunogenetics -- 6.2.2 Electronic medical records and genomics (eMERGE) network -- 6.2.3 Minimum common oncology data elements (mCODE) -- 6.3 Conclusion -- Acknowledgments -- References -- 7 Genomics data sharing -- 7.1 Introduction -- 7.2 Current practices -- 7.3 Case study: H3Africa model -- 7.3.1 Data archive -- 7.3.2 Data sharing, access and release policy -- 7.3.3 Data access committee -- 7.3.4 H3Africa catalog -- 7.4 Beacons -- 7.5 Data commons model -- 7.5.1 Data commons in Africa -- 7.6 Common challenges in genomic data sharing and managing risks -- 7.6.1 ELSI -- 7.6.2 Motivational challenges -- 7.6.3 Technical challenges -- 7.6.4 Infrastructure challenges.
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7.6.5 Economic and political challenges -- 7.6.6 Intellectual property rights -- 7.7 Executive summary -- References -- 8 Data standardization in the omics field -- 8.1 Introduction -- 8.1.1 Defining standardization -- 8.2 Omics data standardization -- 8.2.1 Existing standards and resources -- 8.2.2 Data standardization and FAIR data -- 8.3 Challenges to data standardization -- 8.3.1 Adoption challenges -- 8.3.2 Policy challenges -- 8.4 Executive summary -- Acknowledgments -- Conflict of Interest -- References -- 9 Data sharing: The public's perspective -- 9.1 Public willing to participate? -- 9.2 Concerns unique to genomic data? -- 9.2.1 Data concerns -- 9.2.2 Matters of trust -- 9.3 Support for broad data sharing -- 9.4 A question of context -- 9.5 Policy for the people -- 9.6 Further research -- References -- 10 Genetic data sharing in the view of the EU general data protection regulation (GDPR) -- 10.1 Introduction -- 10.2 The special status of genetic/genomic data -- 10.3 The GDPR framework for scientific research -- 10.4 Consent for genetic data sharing under EU law -- 10.4.1 (Informed) consent for genetic data sharing: two distinct requirements arising from regulatory and ethics frameworks -- 10.4.2 What type of consent is considered valid under the GDPR? -- 10.5 Alternative legal bases for genetic data sharing: shifting attention away from consent -- 10.6 Concluding remarks -- References -- 11 Genomic data sharing and intellectual property -- 11.1 Forms of intellectual property protection for genomic data -- 11.1.1 Copyright -- 11.2 Databases, data protection, and terms of use -- 11.3 Patents -- 11.3.1 Early biotech patents -- 11.3.2 Genetic patents and utility -- 11.3.3 Bermuda and official patent deterrence -- 11.3.4 The Ft. Lauderdale principles -- 11.3.5 NIH's evolving policy toward patenting.
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11.3.6 Patent deterrence outside the United States -- 11.3.7 Nongovernmental limitations on patenting genomic data -- 11.3.8 The SNP consortium and defensive patenting -- 11.3.9 Genetic sequence patents under Myriad11Detailed accounts of the gene patenting litigation involving Myriad Genetics can be found in Refs. [50] and [54]. -- 11.3.10 Diagnostic patents under Mayo -- 11.3.11 Licensing of genomic inventions -- 11.4 Conclusion -- References -- 12 Data governance -- 12.1 Background: precision medicine genomics and governance -- 12.2 How data governance shapes precision medicine -- 12.2.1 Retrospective data integration -- 12.2.2 Prospective data collection -- 12.2.3 Data access -- 12.3 The road ahead: how data governance should shape the future of precision medicine -- References -- Index -- Back cover.
Additional Edition:
Print version: Mccormick, Jennifer B. Genomic Data Sharing San Diego : Elsevier Science & Technology,c2022 ISBN 9780128198032
Language:
English
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