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

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Vaught , supra note 1.

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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.

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Hansson , supra note 21.

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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.

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).

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.

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).

Laurie G. , “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.

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.

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.

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. , “Assessing the Privacy Risks of Data Sharing in Genomics,” Public Health Genomics 14, no. 1 (2011): 17–25.

Laurie G. , 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).

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).

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.

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).

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. , “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).

See Laurie , supra note 2632, at 318.

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.

Kaye J. , “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.

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 , “Broad Consent for Research With Biological Samples: Workshop Conclusions,” American Journal of Bioethics 15, no. 9 (2015): 34–42.

Melham K. , “The Evolution of Withdrawal: Negotiating Research Relationships in Biobanking,” Life Sciences, Society and Policy 10, no. 16 (2014): 1–13.

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.

Kaye J. , “Can I Access My Personal Genome? The Current Legal Position in the UK,” Medical Law Review 22, no. 1 (2014): 64–86.

See Sándor Bárd , supra note 46.

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. , “Genomics and Privacy: Implications of the New Reality of Closed Data for the Field,” PLOS Computational Biology 7, no. 12 (2011): e1002278.

Gan R. , “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.

See Erlich , supra note 40.

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. , “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. , “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.

Kaufman D. J. , “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. , “Biobanking for Research: A Survey of Patient Population Attitudes and Understanding,” Journal of Community Genetics 4, no. 4 (2013): 445–450; Starkbaum J. , “Public Perceptions of Cohort Studies and Biobanks in Germany,” Biopreservation and Biobanking 12, no. 2 (2014): 121–130. But see Ahram M. , “Factors Influencing Public Participation in Biobanking,” European Journal of Human Genetics 22, no. 4 (2014): 445–451.

Franc M. A. , “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.

Rothstein M. A. , “Is Deidentification Sufficient to Protect Health Privacy in Research?” American Journal of Bioethics 10, no. 9 (2010): 3–11; Erlich , supra note 40.

Nuffield Council on Bioethics, supra note 27, at 72; Franc , supra note 54.

Heeney , supra note 35.

Greenbaum , supra note 2949.

Dove E. S. , “Genomic Cloud Computing: Legal and Ethical Points to Consider,” European Journal of Human Genetics 23, no. 10 (2015): 1271–1278.

Heeney , 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).

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. , “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. , “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).

Knoppers B. M. , “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 , “Towards a Data Sharing Code of Conduct,” supra note 19; Budin-Ljøsne I. , “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 , “Data Protection and Sample Management in Biobanking – A Legal Dichotomy,” Genomics, Society and Policy 6, no. 1 (2010): 33–46; Zika , 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. , 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.

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).

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 , supra note 62; Zika , supra note 7.

Kosseim P. , “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.

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.

Briceño Moraia L. , “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.

Zika , supra note 7.

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.

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.

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.

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>.

Dove Knoppers Zawati , supra note 69; Dove , supra note 61.

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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.

Fransson M. N. , “Toward a Common Language for Biobanking,” European Journal of Human Genetics 23, no. 1 (2015): 22–28; Verlinden M. , “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. , “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. , 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).

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).

Moraia Briceño , supra note 67.

European Commission, supra note 64.

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.

European Commission, supra note 64, at 4, 19.

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Greenleaf , supra note 76.

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Kaye , supra note 62; Gibbons M. C. , “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.

Public Population Project in Genomics and Society (P3G), available at <www.p3g.org> (last visited October 13, 2015).

Biobanking and BioMolecular resources Research Infrastructure-European Resources Research Infrastructure Consortium (BBMRI-ERIC), available at <http://bbmri-eric.eu/> (last visited October 13, 2015).

Biobank Standardization and Harmonization for Research Excellence in the European Union (BioSHaRE), available at <https://www.bioshare.eu/> (last visited October 13, 2015).

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