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Biobanks, Data Sharing, and the Drive for a Global Privacy Governance Framework

Published online by Cambridge University Press:  01 January 2021

Edward S. Dove
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Spurred by a confluence of factors, most notably the decreasing cost of high-throughput technologies and advances in information technologies, a number of population research initiatives have emerged in recent years. These include large-scale, internationally collaborative genomic projects (Table 1) and biobanks (Table 2), the latter of which can be defined as an organized collection of human biological material and associated data stored for one or more research purposes. Biobanks are a key emerging research infrastructure, and those established as prospective research resources comprising biospecimens and data from many participants are viewed as particularly promising drivers of biomedical progress. Such biobanks, particularly those publicly funded and set up to promote the public interest, have expanded across the globe in recent years.

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Symposium
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Journal of Law, Medicine & Ethics , Volume 43 , Issue 4 , Winter 2015 , pp. 675 - 689
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Copyright © American Society of Law, Medicine and Ethics 2015

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References

Vaught, J. Bledsoe, M. Watson, P., “Biobanking on Multiple Continents: Will International Coordination Follow?” Biopreservation and Biobanking 12, no. 1 (2014): 1–2.Google Scholar
Biobank Lexicon, Public Population Project in Genomics and Society (P3G), available at <http://www.p3g.org/biobank-lexicon> (last visited October 12, 2015). See also Shaw, D. M. Elger, B. S. Colledge, F., “What Is a Biobank? Differing Definitions among Biobank Stakeholders,” Clinical Genetics 85, no. 3 (2014): 223–227, at 227. Shaw, et al. define a biobank as “any collection of human biological samples and linked data that is to be used for research.”Google Scholar
Vaught, et al. , supra note 1.Google Scholar
Collins, F. S., “Reengineering Translational Science: The Time is Right,” Science Translational Medicine 3 no. 90 (2011): 90cm17; Knoppers, B. M. et al. , “From Genomic Databases to Translation: A Call to Action,” Journal of Medical Ethics 37, no. 8 (2011): 515–516; Harris, J. R. et al. , “Toward a Roadmap in Global Biobanking for Health,” European Journal of Human Genetics 20, no. 11 (2012): 1105–1101.CrossRefGoogle Scholar
Stranger, M. Kaye, J., “Governing Biobanks: An Introduction,” in Kaye, J. Stranger, M., eds., Principles and Practice in Biobank Governance (Surrey, UK: Ashgate, 2009): 1–16; Tracy, R.P., “‘Deep Phenotyping’: Characterizing Populations in the Era of Genomics and Systems Biology,” Current Opinion in Lipidology 19, no. 2 (2008): 151–157.Google Scholar
Rezeli, M. et al. , “Biomarker Discovery Utilizing Biobanking Archives and the Diagnostic Market,” in Marko-Varga, G., ed., Genomics and Proteomics for Clinical Discovery and Development (Dordrecht: Springer, 2014): At 137–146; Olson, J. E. et al. , “Biobanks and Personalized Medicine,” Clinical Genetics 86, no. 1 (2014): 50–55.Google Scholar
Zika, E. et al. , “A European Survey on Biobanks: Trends and Issues,” Public Health Genomics 14, no. 2 (2011): 96–103.CrossRefGoogle Scholar
Recommendation Rec(2006)4 of the Committee of Ministers to Member States on Research on Biological Materials of Human Origin, Council of Europe, (Council of Europe: Strasbourg, 2006), available at <https://wcd.coe.int/wcd/ViewDoc.jsp?id=977859> (last visited October 12, 2015).+(last+visited+October+12,+2015).>Google Scholar
I consider data sharing to include the use, viewing, transfer, linkage, or exchange of data between at least two parties, either openly or under specified access conditions. Data sharing may occur without having the data move from one place to another.Google Scholar
Global Alliance for Genomics and Health, available at <www.genomicsandhealth.org> (last visited October 12, 2015).+(last+visited+October+12,+2015).>Google Scholar
Huang, K. G. Murray, F. E., “Entrepreneurial Experiments in Science Policy: Analyzing the Human Genome Project,” Research Policy 39, no. 5 (2010): 567–582.Google Scholar
Lander, E. S., “Initial Impact of the Sequencing of the Human Genome,” Nature 470, no. 7333 (2011): 187–197; Cooke Bailey, J. N. Pericak-Vance, M. A. Haines, J. L., “The Impact of the Human Genome Project on Complex Disease,” Genes 5, no. 3 (2014): 518–535.Google Scholar
Gisler, M. D. Sornette, D. Woodard, R., “Innovation as a Social Bubble: The Example of the Human Genome Project,” Research Policy 40, no. 10 (2011): 1412–1425.CrossRefGoogle Scholar
Hyman, S. E., “The Meaning of the Human Genome Project for Neuropsychiatric Disorders,” Science 331, no. 6020 (2011): 1026.CrossRefGoogle Scholar
Joly, Y. et al. , “Data Sharing in the Post-Genomic World: The Experience of the International Cancer Genome Consortium (ICGC) Data Access Compliance Office (DACO),” PLOS Computational Biology 8, no. 7 (2012): e1002549.Google Scholar
International Cancer Genome Consortium, available at <www.icgc.org> (last visited October 12, 2015).+(last+visited+October+12,+2015).>Google Scholar
International Cancer Genome Consortium, “International Network of Cancer Genome Projects,” Nature 464, no. 7291X (2010): 993–998; Nik-Zainal, S. et al. , “Mutational Processes Molding the Genomes of 21 Breast Cancers,” Cell 149, no. 5 (2012): 979–993; Hudson, T. J., “Genome Variation and Personalized Cancer Medicine,” Journal of Internal Medicine 274, no. 5 (2013): 440–450.CrossRefGoogle ScholarPubMed
Hu, X. et al. , “The Cancer Genomics and Global Cancer Genome Collaboration,” Science Bulletin 60, no. 1 (2015): 65–70; Stratton, M. R. Campbell, P. J. Futreal, P. A., “The Cancer Genome,” Nature 458, no. 7239 (2009): 719–724; Vaught, J. B. Caboux, E. Hainaut, P., “International Efforts to Develop Biospecimen Best Practices,” Cancer Epidemiology Biomarkers & Prevention 19, no. 4 (2010): 912–915.CrossRefGoogle Scholar
Chalmers, D. R. C. Nicol, D. Otlowski, M. F., “To Share or Not To Share Is the Question,” Applied & Translational Genomics 3, no. 4 (2014): 116–119; Ohno-Machado, L., “To Share or Not to Share: That Is Not the Question,” Science Translational Medicine 4 (2012): 165cm15; Knoppers, B. M. et al. , “Towards a Data Sharing Code of Conduct for International Genomic Research,” Genome Medicine 3, no. 46 (2011): 46. See also Framework for Responsible Sharing of Genomic and Health-Related Data, Global Alliance for Genomics and Health, available at <http://genomicsandhealth.org/about-the-global-alliance/key-documents/framework-responsible-sharing-genomic-and-health-related-data> (last visited October 12, 2015).Google Scholar
Dove, E. S. Laurie, G. T. Knoppers, B. M., “Data Sharing and Privacy,” in Willard, H. F. Ginsburg, G. S., eds., Genomic and Personalized Medicine, 3d ed., Vol. II, Translation and Implementation (Waltham: Elsevier, in press).Google Scholar
The Cancer Genome Atlas Research Network et al., “The Cancer Genome Atlas Pan-Cancer Analysis Project,” Nature Genetics 45, no. 10 (2013): 1113–1120; Fortier, I. et al. , “Is Rigorous Retrospective Harmonization Possible? Application of the DataSHaPER Approach across 53 Large Studies,” International Journal of Epidemiology 40, no. 5 (2011): 1314–1328; Hansson, M. G., “Biobanking within the European Regulatory Framework: Opportunities and Obstacles,” Biopreservation and Biobanking 9, no. 2 (2011): 165–167.Google ScholarPubMed
Chem, R. T. M. et al. , “RD-Connect: An Integrated Platform Connecting Databases, Registries, Biobanks and Clinical Bioinformatics for Rare Disease Research,” Journal of General Internal Medicine 29, no. 3 (2014): 780–787; Horn, E. J. Moore, H. M., “Overcoming Challenges in the Acquisition of Biospecimens for Rare Diseases,” Expert Opinion on Orphan Drugs 2, no. 1 (2014): 1–4; Kohane, I. S. Eran, A., “Can We Measure Autism?” Science Translational Medicine 5, no. 209 (2013): 209ed18; Terry, S. F. et al. , “Advocacy Groups as Research Organizations: The PXE International Example,” Nature Reviews Genetics 8, no. 2 (2007): 157–164.Google Scholar
Hansson, , supra note 21.Google Scholar
Colledge, F. Elger, B. Howard, H. C., “A Review of the Barriers to Sharing in Biobanking,” Biopreservation and Biobanking 11, no. 6 (2013): 339–346; Kaye, J. Hawkins, N., “Data Sharing Policy Design for Consortia: Challenges for Sustainability,” Genome Medicine 6, no. 1 (2014): 4; Foster, M. W. Sharp, R. R., “Share and Share Alike: Deciding How to Distribute the Scientific and Social Benefits of Genomic Data,” Nature Reviews Genetics 8, no. 8 (2007): 633–639.Google Scholar
Human Genome Organization (HUGO), “Summary of Principles Agreed Upon at the First International Strategy Meeting on Human Genome Sequencing (Bermuda, 25–28 February 1996) as reported by HUGOPrinciples Agreed at the First International Strategy Meeting on Human Genome Sequencing: 25–28 February 1996 (Bermuda, 1996),” available at <http://web.ornl.gov/sci/techresources/Human_Genome/research/bermuda.shtml#1> (last visited October 12, 2015); Wellcome Trust, Sharing Data from Large-Scale Biological Research Projects: A System of Tripartite Responsibility (2003), available at <http://www.genome.gov/pages/research/wellcomereport0303.pdf> (last visited October 12, 2015); Toronto International Data Release Workshop Authors et al., “Prepublication Data Sharing,” Nature 461, no. 7261 (2009): 168–170; Wellcome Trust, Sharing Research Data to Improve Public Health: Full Joint Statement by Funders of Health Research (2011), available at http://www.wellcome.ac.uk/About-us/Policy/Spotlight-issues/Data-sharing/Public-health-and-epidemiology/WTDV030690.htm> (last visited October 12, 2015).+(last+visited+October+12,+2015);+Wellcome+Trust,+Sharing+Data+from+Large-Scale+Biological+Research+Projects:+A+System+of+Tripartite+Responsibility+(2003),+available+at++(last+visited+October+12,+2015);+Toronto+International+Data+Release+Workshop+Authors+et+al.,+“Prepublication+Data+Sharing,”+Nature+461,+no.+7261+(2009):+168–170;+Wellcome+Trust,+Sharing+Research+Data+to+Improve+Public+Health:+Full+Joint+Statement+by+Funders+of+Health+Research+(2011),+available+at+http://www.wellcome.ac.uk/About-us/Policy/Spotlight-issues/Data-sharing/Public-health-and-epidemiology/WTDV030690.htm>+(last+visited+October+12,+2015).>Google Scholar
The White House (Office of the Press Secretary), “Fact Sheet: President Obama's Precision Medicine Initiative,” January 30, 2015, available at <http://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative> (last visited October 12, 2015); The White House (Office of the Press Secretary), Remarks made by the President, Prime Minister Tony Blair of England (via satellite), Dr.Collins, Francis, Director of the National Human Genome Research Institute, and Dr. Craig Venter, President and Chief Scientific Officer, Celera Genomics Corporation, on the Completion of the First Survey of the Entire Human Genome Project, Press Release, June 26, 2000, available at <http://www.genome.gov/10001356> (last visited October 12, 2015).Google Scholar
Nuffield Council on Bioethics, The Collection, Linking and Use of Data in Biomedical Research and Health Care: Ethical Issues (London: Nuffield Council on Bioethics, 2015), available at <http://nuffieldbioethics.org/wp-content/uploads/Biological_and_health_data_web.pdf> (last visited October 23, 2015).+(last+visited+October+23,+2015).>Google Scholar
In this article, I presume that biospecimens should be treated as personal data for the purposes of data privacy regulation. Consider, for example, that the European Court of Human Rights has suggested that tissues containing DNA should be subject to the EU data protection regime: S. and Marper v United Kingdom [2008] ECHR 1581.Google Scholar
Warren, S. Brandeis, L., “The Right to Privacy,” Harvard Law Review 4, no. 5 (1890): 193–220; Whitman, J. Q., “The Two Western Cultures of Privacy: Dignity Versus Liberty,” Yale Law Journal 113, no. 1151 (2004): 1151–1221; World Medical Association, Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (2013), available at <http://www.wma.net/en/30publications/10policies/b3/> (last visited October 13, 2015).CrossRefGoogle Scholar
The right to privacy and the right to respect for private life may be seen as overlapping but distinct rights. Generally, the latter right is seen as more expansive than the former. See Bygrave, L. A., “Data Protection Pursuant to the Right to Privacy in Human Rights Treaties,” International Journal of Law and Information Technology 6, no. 3 (1998): 247–284; Moreham, N. A., “The Right to Respect for Private Life in the European Convention on Human Rights: A Re-examination,” European Human Rights Law Review 1, no. 44 (2008): 44–79.Google Scholar
European Union, Charter of Fundamental Rights of the European Union (2010), at Art. 8(1), available at <http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2010:083:0389:0403:en:PDF> (last visited October 13, 2015).+(last+visited+October+13,+2015).>Google Scholar
Laurie, G. et al. , “Managing Access to Biobanks: How Can We Reconcile Individual Privacy and Public Interests in Genetic Research?” Medical Law International 10 (2010): 315–337, at 317. See also Allen, A. L., “Genetic Privacy: Emerging Concepts and Values,” in Rothstein, M. A., ed., Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era (New Haven: Yale University Press, 1997): At 31–59.CrossRefGoogle Scholar
Wang, Y., Human Population Genetic Research in Developing Countries: The Issue of Group Protection (Oxford: Routledge, 2014): At 121; McGregor, J. L., “Population Genomics and Research Ethics with Socially Identifiable Groups,” Journal of Law Medicine & Ethics 35, no. 3 (2007): 356–370.Google Scholar
Joly, Y. Feze, I. N. Simard, J., “Genetic Discrimination and Life Insurance: A Systematic Review of the Evidence,” BMC Medicine, 11, no. 25 (2013): 25; Rothstein, M. A. Joly, Y., “Genetic Information and Insurance Underwriting: Contemporary Issues and Approaches in the Global Economy,” in Atkinson, P. Glasner, P. Lock, M., eds., The Handbook of Genetics & Society: Mapping the New Genomic Era (New York: Routledge, 2009): At 127–144.CrossRefGoogle Scholar
Kaye, J., “The Tension Between Data Sharing and the Protection of Privacy in Genomics Research,” in Mascalzoni, D., ed., Ethics, Law and Governance of Biobanking: National, European and International Approaches (Dordrecht: Springer, 2015): 101–120; Heeney, C. et al. , “Assessing the Privacy Risks of Data Sharing in Genomics,” Public Health Genomics 14, no. 1 (2011): 17–25.CrossRefGoogle Scholar
Laurie, G. et al. , A Review of Evidence Relating to Harm Resulting from Uses of Health and Biomedical Data, June 30, 2014, report prepared for the Nuffield Council on Bioethics Working Party on Biological and Health Data and the Expert Advisory Group on Data Access, available at <http://nuffieldbioethics.org/wp-content/uploads/A-Review-of-Evidence-Relating-to-Harms-Resulting-from-Uses-of-Health-and-Biomedical-Data-FINAL.pdf> (last visited October 13, 2015).+(last+visited+October+13,+2015).>Google Scholar
Otlowski, M. Taylor, S. Bombard, Y., “Genetic Discrimination: International Perspectives,” Annual Review of Genomics and Human Genetics 13 (2012): 433–454; Quinn, G. de Paor, A. Blanck, P., eds., Genetic Discrimination: Transatlantic Perspectives on the Case for a European-level Legal Response (Milton Park: Routledge, 2015). See also S.B. 559, Reg. Sess. (Cal. 2010–2011), available at <http://www.leginfo.ca.gov/pub/1112/bill/sen/sb_0551–0600/sb_559_bill_20110906_chaptered.html> (last visited October 13, 2015); Genetic Information Nondiscrimination Act of 2008, Pub. L. 110–233, 122 Stat. 881 (2008).Google Scholar
Nuffield Council on Bioethics, supra note 27; Knoppers, B. M. Chadwick, R., “Human Genetic Research: Emerging Trends in Ethics,” Nature Reviews Genetics 6, no. 1 (2005): 75–79; Chadwick, R., “The Communitarian Turn: Myth or Reality?” Cambridge Quarterly of Healthcare Ethics 20, no. 4 (2011): 546–553.CrossRefGoogle Scholar
A report from the Council of Canadian Academies suggests that “stewards” are distinct from “custodians”, who in turn might be different to “controllers”. Stewards are seen as using a resource as well as protecting it, and adopting good governance practices, specifically in privacy governance, research governance, information governance, and network governance. See Council of Canadian Academies, Accessing Health and Health-Related Data in Canada (Ottawa: Council of Canadian Academies, 2015), available at <http://www.scienceadvice.ca/en/assessments/completed/health-data.aspx> (last visited October 23, 2015).+(last+visited+October+23,+2015).>Google Scholar
McEwen, J. E. Boyer, J. T. Sun, K. Y., “Evolving Approaches to the Ethical Management of Genomic Data,” Trends in Genetics 29, no. 6 (2013): 375–382; Erlich, Y. et al. , “Redefining Genomic Privacy: Trust and Empowerment,” PLOS Biology 12 (2014): e1001983. See also Lowrance, W. W., Learning from Experience Privacy and the Secondary Use of Data in Health Research (London: Nuffield Trust, 2002): At 34; Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories, ICH (April 2008), available at <http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073162.pdf> (last visited October 13, 2015); Article 29 Data Protection Working Party, Opinion 05/2014 on Anonymization Techniques (April 10, 2014), available at <http://ec.europa.eu/justice/data-protection/article-29/documentation/opinion-recommendation/files/2014/wp216_en.pdf> (last visited October 13, 2015).CrossRefGoogle Scholar
See Laurie, et al. , supra note 2632, at 318.Google Scholar
Knoppers, B. M. Zawati, M. H. Kirby, E. S., “Sampling Populations of Humans across the World: ELSI Issues,” Annual Review of Genomics and Human Genetics 13 (2012): 395–413, at 400.CrossRefGoogle Scholar
Kaye, J. et al. , “Dynamic Consent: A Patient Interface for Twenty-First Century Research Networks,” European Journal of Human Genetics 23, no. 2 (2015): 141–146; Steinsbekk, K. S. Myskja, B. K. Solberg, B., “Broad Consent versus Dynamic Consent in Biobank Research: Is Passive Participation an Ethical Problem?” European Journal of Human Genetics 21, no. 9 (2013): 897–902.CrossRefGoogle Scholar
Broad consent can be defined as consent for an unspecified range of future research subject to a few content and/or process restrictions. See Grady, Christine et al. , “Broad Consent for Research With Biological Samples: Workshop Conclusions,” American Journal of Bioethics 15, no. 9 (2015): 34–42.CrossRefGoogle Scholar
Melham, K. et al. , “The Evolution of Withdrawal: Negotiating Research Relationships in Biobanking,” Life Sciences, Society and Policy 10, no. 16 (2014): 1–13.Google Scholar
Nuffield Council on Bioethics, supra note 27, at 76; Sándor, J. Bárd, P., “Anonymity and Privacy in Biobanking,” in Lenk, C. Sándor, J. Gordijn, B., eds., Biobanks and Tissue Research: The Public, the Patient and the Regulation (Dordrecht: Springer, 2011): 213–230.CrossRefGoogle Scholar
Kaye, J. et al. , “Can I Access My Personal Genome? The Current Legal Position in the UK,” Medical Law Review 22, no. 1 (2014): 64–86.Google Scholar
See Sándor, Bárd, , supra note 46.Google Scholar
Erlich, Y. Narayanan, A., “Routes for Breaching and Protecting Genetic Privacy,” Nature Reviews Genetics 15, no. 6 (2014): 409–421; Lowrance, W. W. Collins, F. S., “Identifiability in Genomic Research,” Science 317, no. 5838 (2007): 600–602; Greenbaum, D. et al. , “Genomics and Privacy: Implications of the New Reality of Closed Data for the Field,” PLOS Computational Biology 7, no. 12 (2011): e1002278.CrossRefGoogle Scholar
Gan, R. et al. , “Chinese Biobanking Initiatives,” Biopreservation and Biobanking 13, no. 1 (2015): 4–7, at 6, noting that the China National Gene-Bank (CNGB) in Shenzhen has collected more than 1.5 million traceable biospecimens and has stored 20 petabytes of data.CrossRefGoogle Scholar
See Erlich, et al. , supra note 40.Google Scholar
Lin, Z. Owen, A. B. Altman, R. B., “Genomic Research and Human Subject Privacy,” Science 305, no. 5681 (2004): 183; Malin, B. Sweeney, L., “How (Not) to Protect Genomic Data Privacy in a Distributed Network: Using Trail Re-identification to Evaluate and Design Anonymity Protection Systems,” Journal of Biomedical Informatics 37, no. 3 (2004): 179; Homer, N. et al. , “Resolving Individuals Contributing Trace Amounts of DNA to Highly Complex Mixtures Using High-Density SNP Genotyping Microarrays,” PLOS Genetics, 4, no. 8 (2008): e1000167; Nyholt, D. R. Yu, C.-E. Visscher, P. M., “On Jim Watson's APOE Status: Genetic Information Is Hard to Hide,” European Journal of Human Genetics 17, no. 2 (2009): 147–149; Im, H. K. et al. , “On Sharing Quantitative Trait GWAS Results in an Era of Multiple-Omics Data and the Limits of Genomic Privacy,” American Journal of Human Genetics 90, no. 4 (2012): 591–598; Schadt, E. E. Woo, S. Hao, K., “Bayesian Method to Predict Individual SNP Genotypes from Gene Expression Data,” Nature Genetics 44, no. 5 (2012): 603–660; Erlich, Narayanan, , supra note 49.CrossRefGoogle Scholar
Kaufman, D. J. et al. , “Public Opinion about the Importance of Privacy in Biobank Research,” American Journal of Human Genetics 85, no. 5 (2009): 643–654; Ursin, L. Ø. Steinsbekk, K. S., “Peeking into the Black Box of Privacy – Biobank Participants on the Importance of Recognition,” Norsk Epidemiologi 21, no. 2 (2012): 269–276; Igbe, M. A. Adebamowo, C. A., “Qualitative Study of Knowledge and Attitudes to Biobanking among Lay Persons in Nigeria,” BMC Medical Ethics 13, no. 27 (2012); Rahm, A. K. et al. , “Biobanking for Research: A Survey of Patient Population Attitudes and Understanding,” Journal of Community Genetics 4, no. 4 (2013): 445–450; Starkbaum, J. et al. , “Public Perceptions of Cohort Studies and Biobanks in Germany,” Biopreservation and Biobanking 12, no. 2 (2014): 121–130. But see Ahram, M. et al. , “Factors Influencing Public Participation in Biobanking,” European Journal of Human Genetics 22, no. 4 (2014): 445–451.Google Scholar
Franc, M. A. et al. , “Coding of DNA Samples and Data in the Pharmaceutical Industry: Current Practices and Future Directions – Perspective of the I-PWG,” Clinical Pharmacology & Therapeutics 89, no. 4 (2011): 537–545.CrossRefGoogle Scholar
Rothstein, M. A., “Is Deidentification Sufficient to Protect Health Privacy in Research?” American Journal of Bioethics 10, no. 9 (2010): 3–11; Erlich, et al. , supra note 40.CrossRefGoogle Scholar
Nuffield Council on Bioethics, supra note 27, at 72; Franc, et al. , supra note 54.Google Scholar
Heeney, et al. , supra note 35.Google Scholar
Greenbaum, et al. , supra note 2949.Google Scholar
Dove, E. S. et al. , “Genomic Cloud Computing: Legal and Ethical Points to Consider,” European Journal of Human Genetics 23, no. 10 (2015): 1271–1278.CrossRefGoogle Scholar
Heeney, et al. , supra note 35; Wjst, M., “Caught You: Threats to Confidentiality Due to the Public Release of Large-Scale Genetic Data Sets,” BMC Medical Ethics 11, no. 21 (2010).Google Scholar
Nuffield Council on Bioethics, supra note 27; Dove, E. S., “The Genetic Privacy Carousel: A Discourse on Proposed Genetic Privacy Bills and the Co-Evolution of Law and Science,” Current Pharmacogenomics and Personalized Medicine 9, no. 4 (2011): 252–263; Budin-Ljøsne, I. et al. , “ELSI Challenges and Strategies of National Biobank Infrastructures,” Norsk Epidemiologi 21, no. 2 (2012): 155–160; Rial-Sebbag, E. Cambon-Thomsen, A., “The Emergence of Biobanks in the Legal Landscape: Towards a New Model of Governance,” Journal of Law and Society 39, no. 1 (2012): 113–130; Dove, E. S. et al. , “Charting the Privacy Landscape in Canadian Paediatric Biobanks,” Health Law Journal 20 (2013): 1–46; Forsberg, J. S. Soini, S., “A Big Step for Finnish Biobanking,” Nature Reviews Genetics 15, no. 6 (2014); Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada (Ottawa: Interagency Secretariat on Research Ethics, 2014), available at <http://www.pre.ethics.gc.ca/pdf/eng/tcps2–2014/TCPS_2_FINAL_Web.pdf> (last visited October 13, 2015); NIH Genomic Data Sharing Policy, National Institutes of Health, available at <http://gds.nih.gov/PDF/NIH_GDS_Policy.pdf> (last visited October 13, 2015).Google Scholar
Knoppers, B. M. et al. , “A Human Rights Approach to an International Code of Conduct for Genomic and Clinical Data Sharing,” Human Genetics 133, no. 7 (2014): 895–903; Knoppers, et al. , “Towards a Data Sharing Code of Conduct,” supra note 19; Budin-Ljøsne, I. et al. , “Data Sharing in Large Research Consortia: Experiences and Recommendations from ENGAGE,” European Journal of Human Genetics 22 (2014): 317–321; Schulte, T. In den Bäumen, et al. , “Data Protection and Sample Management in Biobanking – A Legal Dichotomy,” Genomics, Society and Policy 6, no. 1 (2010): 33–46; Zika, et al. , supra note 7; Kaye, J., “From Single Biobanks to International Networks: Developing e-Governance,” Human Genetics 130, no. 3 (2011): 377–382; Chalmers, D., “Genetic Research and Biobanks,” Methods in Molecular Biology 675 (2011): 1–37; Elger, B. S. Caplan, A. L., “Consent and Anonymization in Research Involving Biobanks: Differing Terms and Norms Present Serious Barriers to an International Framework,” EMBO Reports 7, no. 7 (2006): 661–666; Sándor and Bárd, supra note 46; Knoppers, B. M. Saginur, M., “The Babel of Genetic Data Terminology,” Nature Biotechonlogy 23, no. 8 (2005): 925–927; Burton, P. Fortier, I. Knoppers, B. M., “The Global Emergence of Epidemiological Biobanks: Opportunities and Challenges,” in Khoury, M. et al. , eds., Human Genome Epidemiology: Building the Evidence for Using Genetic Information to Improve Health and Prevent Disease, 2d ed. (New York: Oxford University Press, 2009): 77–100.CrossRefGoogle Scholar
OECD Guidelines on the Protection of Privacy and Transborder Flows of Personal Data, Organisation for Economic Cooperation and Development (OECD) (1980), at Preamble (‘[T] here is a danger that disparities in national legislations could hamper the free flow of personal data across frontiers’), available at <http://www.oecd.org/sti/ieconomy/oecdguidelinesontheprotectionofprivacyandtransborderflowsofpersonaldata.htm> (last visited October 13, 2015).+(last+visited+October+13,+2015).>Google Scholar
Proposal for a Regulation of the European Parliament and of the Council on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data (General Data Protection Regulation), European Commission, January 25, 2012, available at <http://ec.europa.eu/justice/data-protection/document/review2012/com_2012_11_en.pdf> (last visited October 13, 2015); Knoppers, et al. , supra note 62; Zika, et al. , supra note 7.Google Scholar
Kosseim, P. et al. , “Building a Data Sharing Model for Global Genomic Research,” Genome Biology 15, no. 430 (2014); Vaught, Caboux, Hainaut, supra note 18; Kiehntopf, M. Krawczak, M., “Biobanking and International Interoperability: Samples,” Human Genetics 130, no. 3 (2011): 369–376.Google Scholar
Weber, R. H., “Transborder Data Transfers: Concepts, Regulatory Approaches and New Legislative Initiatives,” International Data Privacy Law 3, no. 2 (2013): 117–130, at 118–119.CrossRefGoogle Scholar
Briceño Moraia, L. et al. , “A Comparative Analysis of the Requirements for the Use of Data in Biobanks based in Finland, Germany, the Netherlands, Norway and the United Kingdom,” Medical Law International 14, no. 4 (2014): 187–212. See also Burton, Fortier, Knoppers, supra note 62.CrossRefGoogle Scholar
Zika, et al. , supra note 7.Google Scholar
Dove, E. S. Knoppers, B. M. Zawati, M. H., “Towards an Ethics Safe Harbor for Global Biomedical Research,” Journal of Law and the Biosciences 1, no. 1 (2014): 3–51, at 16–17.Google Scholar
Lemmens, T. Austin, L. M., “The End of Individual Control over Health Information: Governing Biobanks and Promoting Fair Information Practices,” in Kaye, Stranger, , supra note 5, at 243–266.Google Scholar
Austin, L. M. Lemmens, T., “Privacy, Consent, and Governance,” in Dierickx, K. Borry, P., eds., New Challenges for Biobanks: Ethics, Law and Governance (Antwerpen: Intersentia, 2009): At 111–122.Google Scholar
Yeo, M., Looking Out from Inside the Panopticon: A Privacy Perspective on Biobanking, analytic paper commissioned by the Office of the Privacy Commissioner of Canada for 29th International Conference of Data Protection and Privacy Commissioners (2007), at 33, available at <http://www.laurentian.ca/NR/rdonlyres/B012500E-1491-4BCE-9C22–8AD0A77A3F64/0/PrivacyandBiobankingPrivacyCommissionofCanada.pdf>..>Google Scholar
Dove, Knoppers, Zawati, , supra note 69; Dove, et al. , supra note 61.Google Scholar
Government Accountability Office, Medical Records Privacy: Uses and Oversight of Patient Information in Research (Washington, DC: GAO, 1999), available at <http://www.gao.gov/archive/1999/he99070t.pdf> (last visited October 13, 2015); Government Accountability Office, Medical Records Privacy: Access Needed for Health Research, but Oversight of Privacy Protections Is Limited (Washington, D.C.: GAO, 1999), available at <http://www.gao.gov/archive/1999/he99055.pdf> (last visited October 13, 2015).+(last+visited+October+13,+2015);+Government+Accountability+Office,+Medical+Records+Privacy:+Access+Needed+for+Health+Research,+but+Oversight+of+Privacy+Protections+Is+Limited+(Washington,+D.C.:+GAO,+1999),+available+at++(last+visited+October+13,+2015).>Google Scholar
Knoppers, Saginur, , supra note 62; Elger, Caplan, , supra note 62; Gassner, U. M., “Legal Aspects of Tissue Banking,” Pathobiology 74, no. 4 (2007): 270–274.Google Scholar
Fransson, M. N. et al. , “Toward a Common Language for Biobanking,” European Journal of Human Genetics 23, no. 1 (2015): 22–28; Verlinden, M. et al. , “Access to Biobanks: Harmonization Across Biobank Initiatives,” Biopreservation and Biobanking 12, no. 6 (2014): 415–422; Gunasekara, G., “Paddling in Unison or Just Paddling? International Trends in Reforming Information Privacy Law,” International Journal of Law and Information Technology 22, no. 2 (2014): 141–177; Tassé, A.-M., “From ICH to IBH in Biobanking? A Legal Perspective on Harmonization, Standardization and Unification,” Studies in Ethics, Law, and Technology 7, no. 1 (2013): 1–15; Doiron, D. et al. , “Data Harmonization and Federated Analysis of Population-Based Studies: The BioSHaRE Project,” Emerging Themes in Epidemiology 10, no. 1 (2013): 12; Greenleaf, G., “The Influence of European Data Privacy Standards outside Europe: Implications for Globalization of Convention 108,” International Data Privacy Law 2, no. 2 (2012): 68–92; Cécile de Terwangne, , “Is a Global Data Protection Regulatory Model Possible?” in Gutwirth, S. et al. , eds., Reinventing Data Protection? (Dordrecht: Springer, 2009): 175–189. See also E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories, International Conference on Harmonization (ICH) (2007), available at <http://www.fda.gov/RegulatoryInformation/Guidances/ucm129286.htm> (last visited October 13, 2015).Google Scholar
Knoppers, B. M. Abdul-Rahman, M. H. Bédard, K., “Genomic Databases and International Collaboration,” King's Law Journal 18, no. 2 (2007): 291–312. The Global Alliance for Genomics and Health has developed a table of concordance of data privacy mechanisms. See Global Alliance for Genomics and Health, Privacy and Security Policy, available at <http://genomicsandhealth.org/work-products-demonstration-projects/privacy-and-security-policy> (last visited October 23, 2015).CrossRefGoogle Scholar
Moraia, Briceño et al. , supra note 67.Google Scholar
European Commission, supra note 64.Google Scholar
De Hert, P. Papakonstantinou, V., “The Proposed Data Protection Regulation Replacing Directive 95/46/EC: A Sound System for the Protection of Individuals,” Computer Law & Security Review 28, no. 2 (2012): 130–142; Costa, L. Poullet, Y., “Privacy and the Regulation of 2012,” Computer Law & Security Review 28, no. 3 (2012): 254–262. But see Blume, P., “The Myths Pertaining to the Proposed General Data Protection Regulation,” International Data Privacy Law 4, no. 4 (2014): 269–273, at 271–272.Google Scholar
European Commission, supra note 64, at 4, 19.Google Scholar
Fears, R. et al. , “Data Protection Regulation and the Promotion of Health Research: Getting the Balance Right,” QJM: An International Journal of Medicine 107, no. 1 (2014): 3–5; Sethi, N., “The Promotion of Data Sharing in Pharmacoepidemiology,” European Journal of Health Law 21, no. 3 (2014): 271–296; Dove, E. S. Townend, D. Knoppers, B. M., “Data Protection and Consent to Biomedical Research: A Step Forward?” The Lancet 384, no. 9946 (2014): 855; Di Iorio, C. T. Carinci, F. Oderkirk, J., “Health Research and Systems' Governance are at Risk: Should the Right to Data Protection Override Health?” Journal of Medical Ethics 40, no. 7 (2014): 488–492; Casali, P.G. et al. , “Risks of the New EU Data Protection Regulation: An ESMO Position Paper Endorsed by the European Oncology Community,” Annals of Oncology 25, no. 8 (2014): 1458–1461; Ploem, M. C. Essink-Bot, M. L. Stronks, K., “Proposed EU data Protection Regulation Is a Threat to Medical Research,” BMJ 346, no. f3534 (2013): f3534.CrossRefGoogle Scholar
Greenleaf, , supra note 76.Google Scholar
International Standards on the Protection of Personal Data and Privacy: The Madrid Resolution, International Conference of Data Protection and Privacy Commissioners (2009), available at <http://www.privacycommission.be/sites/privacycommission/files/documents/international_standards_madrid_2009.pdf> (last visited October 13, 2015).+(last+visited+October+13,+2015).>Google Scholar
Kaye, , supra note 62; Gibbons, M. C. et al. , “Governing Genetic Databases: Challenges Facing Research Regulation and Practice,” Journal of Law and Society 34, no. 2 (2007): 163–189; Kaye, J., “Do We Need a Uniform Regulatory System for Biobanks across Europe?” European Journal of Human Genetics 14, no. 2 (2006): 245–248.Google Scholar
Public Population Project in Genomics and Society (P3G), available at <www.p3g.org> (last visited October 13, 2015).+(last+visited+October+13,+2015).>Google Scholar
Biobanking and BioMolecular resources Research Infrastructure-European Resources Research Infrastructure Consortium (BBMRI-ERIC), available at <http://bbmri-eric.eu/> (last visited October 13, 2015).+(last+visited+October+13,+2015).>Google Scholar
Biobank Standardization and Harmonization for Research Excellence in the European Union (BioSHaRE), available at <https://www.bioshare.eu/> (last visited October 13, 2015).+(last+visited+October+13,+2015).>Google Scholar
International Society for Biological and Environmental Repositories (ISBER), available at <http://www.isber.org/> (last visited October 13, 2015).+(last+visited+October+13,+2015).>Google Scholar
Laurie, et al. , supra note 32, at 318.Google Scholar
Dove, E. S. Phillips, M., “Privacy Law, Data Sharing Policies, and Medical Data: A Comparative Perspective,” in Loukides, G. Gkoulalas-Divanis, A., eds., Medical Data Privacy Handbook (Dordrecht: Springer, in press).Google Scholar