Creating a data resource: what will it take to build a medical information commons?

Springer Science and Business Media LLC - Tập 9 - Trang 1-5 - 2017
Patricia A. Deverka1, Mary A. Majumder2, Angela G. Villanueva2, Margaret Anderson3, Annette C. Bakker4, Jessica Bardill5, Eric Boerwinkle6, Tania Bubela7, Barbara J. Evans8, Nanibaa’ A. Garrison9, Richard A. Gibbs10, Robert Gentleman11, David Glazer12, Melissa M. Goldstein13, Hank Greely14, Crane Harris15, Bartha M. Knoppers16, Barbara A. Koenig17, Isaac S. Kohane18, Salvatore La Rosa4, John Mattison19, Christopher J. O’Donnell20, Arti K. Rai21, Heidi L. Rehm22, Laura L. Rodriguez23, Robert Shelton24, Tania Simoncelli25, Sharon F. Terry26, Michael S. Watson27, John Wilbanks28, Robert Cook-Deegan29, Amy L. McGuire2
1American Institutes for Research, Health Care Group, Chapel Hill, USA
2Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, USA
3Deloitte, 1919 N Lynn, Arlington, USA
4Children’s Tumor Foundation, New York, USA
5Department of English, Concordia University, Montreal, Canada
6Human Genetics Center, School of Public Health, The University of Texas Health Science Center at Houston and Human Genome Sequencing Center, Baylor College of Medicine, Houston, USA
7Faculty of Health Sciences, Simon Fraser University, Burnaby, Canada
8Law Center and Department of Electrical and Computer Engineering, University of Houston, Houston, USA
9Treuman Katz Center for Pediatric Bioethics, Seattle Children’s Research Institutes, Seattle, USA
10Human Genome Sequencing Center, Baylor College of Medicine, Houston, USA
1123andMe, Mountain View, USA
12Verily Life Sciences LLC, South San Francisco, USA
13Milken Institute School of Public Health, The Georgetown Washington University, Washington, DC, USA
14Center for Law and the Biosciences, Stanford University, Stanford, USA
15Illumina, Inc., 5200 Research Pl, San Diego, USA
16Centre of Genomics and Policy, McGill University, Montreal, Canada
17Institute for Health and Aging, and Department of Anthropology, History, and Social Medicine, University of California San Francisco, San Francisco, USA
18Department of Biomedical Informatics, Harvard Medical School, Boston, USA
19Kaiser Permanente, University of California San Diego and Singularity University, San Diego, USA
20Center for Population Genomics, Boston Veterans Administration Healthcare, Framingham, USA
21Duke University School of Law; Duke Innovation and Entrepreneurship Initiative, Durham, USA
22Harvard Medical School, Brigham and Women’s Hospital and The Broad Institute of MIT and Harvard, Cambridge, USA
23Division of Policy, Communications, and Education, National Human Genome Research Institute 31 Center Drive, Bethesda, USA
24Private Access, Inc, Irvine, USA
25Broad Institute of Harvard and MIT, Cambridge, USA
26Genetic Alliance, Washington, DC, USA;
27American College of Medical Genetics and Genomics, Bethesda, USA
28Sage Bionetworks, Seattle, USA
29School for the Future of Innovation in Society and Consortium for Science, Policy and Outcomes, Arizona State University, and Senior Fellow, FasterCures, a Center of the Milken Institute, Washington, DC, USA

Tóm tắt

National and international public–private partnerships, consortia, and government initiatives are underway to collect and share genomic, personal, and healthcare data on a massive scale. Ideally, these efforts will contribute to the creation of a medical information commons (MIC), a comprehensive data resource that is widely available for both research and clinical uses. Stakeholder participation is essential in clarifying goals, deepening understanding of areas of complexity, and addressing long-standing policy concerns such as privacy and security and data ownership. This article describes eight core principles proposed by a diverse group of expert stakeholders to guide the formation of a successful, sustainable MIC. These principles promote formation of an ethically sound, inclusive, participant-centric MIC and provide a framework for advancing the policy response to data-sharing opportunities and challenges.

Tài liệu tham khảo

The NationalAcademies Press. Toward precision medicine: building a knowledge network for biomedical research and a new taxonomy of disease. 2011. https://www.nap.edu/catalog/13284/toward-precision-medicine-building-a-knowledge-network-for-biomedical-research. Accessed 8 September 2017. Cook-Deegan R, Ankeny RA, Jones KM. Sharing data to build a medical information commons: from Bermuda to the Global Alliance. Annu Rev Genomics Hum Genet. 2017;18:389–415. Ostrom E. Analyzing long-enduring, self-organized, and self-governed CPRs. In: Governing the commons: the evolution of institutions for collective action. 1st ed. Cambridge; New York: Cambridge University Press; 1990. p. 58–102. Hess C, Ostrom E, editors. Understanding knowledge as a commons: from theory to practice. Cambridge: MIT Press; 2007. Schofield PN, Bubela T, Weaver T, Portilla L, Brown SD, Hancock JM, et al. Post-publication sharing of data and tools. Nature. 2009;461:171–3. Evans BJ. Barbarians at the gate: consumer-driven health data commons and the transformation of citizen science. SSRN Scholarly Paper. Rochester: Social Science Research Network; 2016. https://papers.ssrn.com/abstract = 2750347. Accessed 8 September 2017. Evans BJ. Power to the people: data citizens in the age of precision medicine. Vanderbilt Entertainment and Technology Law. 2016;19:243–65. Erlich Y, Williams JB, Glazer D, Yocum K, Farahany N, Olson M, et al. Redefining genomic privacy: trust and empowerment. PLoS Biol. 2014;12:e1001983. National Congress of American Indians. American Indian and Alaska Native Genetics Resource Center. http://genetics.ncai.org/. Accessed 8 Sept 2017. Joosten YA, Israel TL, Williams NA, Boone LR, Schlundt DG, Mouton CP, et al. Community engagement studios: a structured approach to obtaining meaningful input from stakeholders to inform research. Acad Med. 2015;90:1646–50. Evans BJ, Dorschner MO, Burke W, Jarvik GP. Regulatory changes raise troubling questions for genomic testing. Genet Med. 2014;16:799–803. Mattison J. Secondary use of protected health information. In: Information privacy in the evolving healthcare environment. HIMSS; 2013. p. 149–70. Stead WW. Recommendations on de-identification of protected health information under HIPAA. 2017. https://www.ncvhs.hhs.gov/wp-content/uploads/2013/12/2017-Ltr-Privacy-DeIdentification-Feb-23-Final-w-sig.pdf. Accessed 8 Sept 2017 McGuire AL, Oliver JM, Slashinski MJ, Graves JL, Wang T, Kelly PA, et al. To share or not to share: a randomized trial of consent for data sharing in genome research. Genet Med. 2011;13:948–55. Burstein MD, Robinson JO, Hilsenbeck SG, McGuire AL, Lau CC. Pediatric data sharing in genomic research: attitudes and preferences of parents. Pediatrics. 2014;133:690–7. Shelton RH. Electronic consent channels: preserving patient privacy without handcuffing researchers. Sci Transl Med. 2011;3:69cm4. Kaye J, Whitley EA, Lund D, Morrison M, Teare H, Melham K. Dynamic consent: a patient interface for twenty-first century research networks. Eur J Hum Genet. 2015;23:141–6. Horn EJ, Edwards K, Terry SF. Engaging research participants and building trust. Genet Test Mol Biomarkers. 2011;15:839–40. Moore v. Regents of the University of California, 51 Cal. 3d 120 (1990); 271 Cal. Rptr. 146; 793 P.2d 479 [https://www.courtlistener.com/opinion/2608931/moore-v-regents-of-university-of-california/] Greenberg v. Miami Children’s Hospital Res. Inst., Inc., 264 F. Supp. 2d 1064 (S.D. Fl. 2003) [https://www.courtlistener.com/opinion/2507167/greenberg-v-miami-childrens-hospital-res-inst-inc/] Washington University v. Catalona, 437 F. Supp. 2d 985 (E.D.Mo. 2006) [https://www.courtlistener.com/opinion/2492481/washington-university-v-catalona/]
Thông tin
Thông tin xuất bản

Springer Science and Business Media LLC

Tập 9

1-5

Thông tin tác giả