Skip to main content
SpringerLink
Log in
Book cover

Ethics, Law and Governance of Biobanking pp 101–120Cite as

The Tension Between Data Sharing and the Protection of Privacy in Genomics Research

  • Chapter
  • First Online:

Part of the book series: The International Library of Ethics, Law and Technology ((ELTE,volume 14))

Abstract

With the costs of sequencing technology falling rapidly, we are moving to a position where whole-genome scanning of individual DNA samples will start to become routine in medical research and clinical medicine. This is also a critical point in time for the building of infrastructure and the linkage of existing biobanks and bioclinical projects. These plans are starting to be operationalized to enable the sharing of data and samples in a systematic way on a large scale. However, the meta-level governance mechanisms that are needed to support this are still in development. The move to global data sharing has been facilitated by funding bodies on both sides of the Atlantic, which have supported large international collaborative projects and developed open access policies to encourage wide-scale data sharing.

This chapter has been already published as: Kaye (2012b). The Tension Between Data Sharing and the Protection of Privacy in Genomics Research. Annual Review of Genomics and Human Genetics 13:415–31. We kindly thank the publisher for allowing the reprint.

This is a preview of subscription content, log in via an institution.

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD   109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Learn about institutional subscriptions

References

  • Aldhous P. 2009. Genome sequencing falls to $5000. New Scientist, (February 6), http://www.newscientist.com/article/dn16552-genome-sequencing-falls-to-5000.html.

  • Arnason, V. 2004. Coding and consent: Moral challenges of the database project in Iceland. Bioethics 18: 27–49.

    Article  PubMed  Google Scholar 

  • Anderson N, and Edwards K. 2010. Building a chain of trust: using policy and practice to enhance trustworthy clinical data discovery and sharing. In Proceedings of the workshop on governance of technology, information and policies, 15–20. Austin, TX, December 7, New York: Association of Computing Machinery.

    Google Scholar 

  • Beskow, L.M., W. Burke, J.F. Merz, P.A. Barr, S. Terry, et al. 2001. Informed consent for population-based research involving genetics. JAMA 286: 2315–2321.

    Article  CAS  PubMed  Google Scholar 

  • Birney, E., T.J. Hudson, E.D. Green, C. Gunter, S. Eddy, et al. 2009. Prepublication data sharing. Nature 461: 168–170.

    Article  PubMed  Google Scholar 

  • Boddington, P., L. Curren, J. Kaye, N. Kanellopoulou, K. Melham, et al. 2011. Consent forms in genomics: The difference between law and practice. European Journal of Health Law 18: 491–519.

    Article  PubMed  Google Scholar 

  • Burton, P.R., A.L. Hansell, I. Fortier, and T.A. Manolio. 2009. Size matters: Just how Big is BIG? Quantifying realistic sample size requirements for human genome epidemiology. International Journal of Epidemiology 38: 263–273.

    Article  PubMed Central  PubMed  Google Scholar 

  • Busby, H. 2004. Blood donation for genetic research: What can we learn from donors’ narratives? In Genetic databases: Socio-Ethical issues in the collection and use of DNA, ed. R. Tutton, and O. Corrigan, 39–56. London: Routledge.

    Google Scholar 

  • Butler, D. 2010. Human genome at ten: Science after the sequence. Nature 465: 1000–1001.

    Article  CAS  PubMed  Google Scholar 

  • Cambon-Thomsen, A. 2004. The social and ethical issues of post-genomic biobanks. Nature Reviews Genetics 5: 866–873.

    Article  CAS  PubMed  Google Scholar 

  • Caulfield, T., and J. Kaye. 2009. Broad consent in biobanking: Reflections on seemingly insurmountable dilemmas. Medical Law International 10: 85–100.

    Article  Google Scholar 

  • Colins, F.S., M. Morgan, and A. Patrinos. 2003. The human genome project: Lessons from large-scale biology. Science 300: 286–290.

    Article  Google Scholar 

  • Dalton, R. 2004. When two tribes go to war. Nature 430: 500–502.

    Article  CAS  PubMed  Google Scholar 

  • Day, N. 2009. Commentary: How small is small? International Journal of Epidemiology 38: 274–275.

    Article  PubMed  Google Scholar 

  • Genetic Association Information Network (GAIN). 2007. New models of collaboration in genome-wide association studies: The genetic association information network. Nature Genetics 39: 1045–1051.

    Article  Google Scholar 

  • Gertz, R. 2008. Withdrawing from participating in a biobank—A comparative study. European Journal of Health Law 15: 381–389.

    Article  PubMed  Google Scholar 

  • Gibbs, R. 2005. Deeper into the genome. Nature 437: 1233–1234.

    Article  CAS  PubMed  Google Scholar 

  • Gitschier, J. 2009. Inferential genotyping of Y chromosomes in latter-day saints founders and comparison to Utah samples in the HapMap project. American Journal of Human Genetics 84: 251–258.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  • Gitter, D.M. 2011. The challenges of achieving open-source sharing of biobank data. Biotechnology Law Report 29: 623–635.

    Article  Google Scholar 

  • Greenbaum, D., A. Sboner, X.J. Mu, and M. Gerstein. 2011. Genomics and privacy: Implications of the new reality of closed data for the field. PLoS Computational Biology 7: e1002278.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  • Haga, S.B., and L.M. Beskow. 2008. Ethical, legal, and social implications of biobanks for genetics research. Advances in Genetics 60: 505–544.

    Article  PubMed  Google Scholar 

  • Hallowell, N., S. Cooke, G. Crawford, A. Lucassen, M. Parker, and C. Snowdon. 2010. An investigation of patients’ motivations for their participation in genetics-related research. Journal of Medical Ethics 36: 37–45.

    Article  CAS  PubMed  Google Scholar 

  • Hattersley, A.T., and M.I. McCarthy. 2005. What makes a good genetic association study? Lancet 366: 1315–1323.

    Article  PubMed  Google Scholar 

  • Heeney, C., N. Hawkins, J. de Vries, P. Boddington, and J. Kaye. 2011. Assessing the privacy risks of data sharing in genomics. Public Health Genomics 14: 17–25.

    Article  CAS  PubMed  Google Scholar 

  • Holm, S. 2011. Withdrawing from research: A rethink in the context of research biobanks. Health Care Analysis 19: 269–281.

    Article  PubMed  Google Scholar 

  • Homer, N., S. Szelinger, M. Redman, D. Duggan, W. Tembe, et al. 2008. Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping micro arrays. PLoS Genetics 4: e1000167.

    Article  PubMed Central  PubMed  Google Scholar 

  • Human Genome Organisation (HUGO). 1996. Summary of principles agreed at the first international strategy meeting on human genome sequencing. Bermuda, (February 25–28), http://www.ornl.gov/sci/techresources/Human_Genome/research/bermuda.shtml#1.

  • Hudson, K.L. 2011. Genomics, health care, and society. New England Journal of Medicine 365: 1033–1041.

    Article  CAS  PubMed  Google Scholar 

  • Ioannidis, J.P., P. Boffetta, J. Little, T.R. O’Brien, A.G. Uitterlinden, et al. 2008. Assessment of cumulative evidence on genetic associations: Interim guidelines. International Journal of Epidemiology 37: 120–132.

    Article  PubMed  Google Scholar 

  • Johnson, A.D., R. Leslie, and C.J. O’Donnell. 2011. Temporal trends in results availability from genome-wide association studies. PLoS Genetics 7: e1002269.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  • Kahn, J.P., A.C. Mastroianni, and J. Sugarman (eds.). 1998. Beyond consent: Seeking justice in research. Oxford, UK: Oxford University Press.

    Google Scholar 

  • Kaye, J. 2009. Biobanking networks: What are the governance challenges? In Principles and practice in biobank governance, ed. J. Kaye, and M. Stranger, 201–213. Farnham, UK: Ashgate.

    Google Scholar 

  • Kaye, J. 2011. From single biobanks to international networks: Developing e-governance. Human Genetics 130: 377–382.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  • Kaye, J., L. Curren, N. Anderson, K. Edwards, S.M. Fullerton, et al. 2012a. User-centric initiatives in health and biomedical research. Nature Reviews Genetics 13(5): 371–376.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  • Kaye, J., S.M.C. Gibbons, C. Heeney, M. Parker, and A. Smart. 2012b. Governing biobanks: Understanding the interplay between law and practice. Oxford, UK: Hart.

    Google Scholar 

  • Kaye, J., C. Heeney, N. Hawkins, J. de Vries, and P. Boddington. 2009. Data sharing in genomics—Re-shaping scientific practice. Nature Reviews Genetics 5: 331–335.

    Article  Google Scholar 

  • Knoppers, B.M., and Y. Joly. 2007. Our social genome? Trends in Biotechnology 25: 284–288.

    Article  CAS  PubMed  Google Scholar 

  • Kohane, I.S., and R.B. Altman. 2005. Health-information altruists—A potentially critical resource. New England Journal of Medicine 353: 2074–2077.

    Article  CAS  PubMed  Google Scholar 

  • Laurie, G., P. Mallia, D.A. Frenkel, A. Krajewska, H. Moniz, et al. 2010. Managing access to biobanks: How can we reconcile individual privacy and public interests in genetic research? Medical and Law International 10: 315–337.

    Article  Google Scholar 

  • Little, J., J.P. Higgins, J.P. Ioannidis, D. Moher, F. Gagnon, et al. 2009. Strengthening the reporting of genetic association studies (STREGA): An extension of the STROBE statement. PLoS Medicine 6: e22.

    Article  PubMed  Google Scholar 

  • Ludman, E.J., S.M. Fullerton, L. Spangler, S.B. Trinidad, M.M. Fujii, et al. 2010. Glad you asked: participants’ opinions of re-consent for dbGap data submission. Journal of Empirical Research on Human Research Ethics 5: 9–16.

    Article  PubMed Central  PubMed  Google Scholar 

  • Lumley, T., and K. Rice. 2010. Potential for revealing individual-level information in genome-wide association studies. JAMA 303: 659–660.

    Article  CAS  PubMed  Google Scholar 

  • Lunshof, J.E., R. Chadwick, D.B. Vorhaus, and G.M. Church. 2008. From genetic privacy to open consent. Nature Reviews Genetics 9: 406–411.

    Article  CAS  PubMed  Google Scholar 

  • Malin, B., D. Karp, and R.H. Scheuermann. 2010. Technical and policy approaches to balancing patient privacy and data sharing in clinical and translational research. Journal of Investigative Medicine 58: 11–18.

    PubMed Central  PubMed  Google Scholar 

  • Mardis, E.R. 2011. A decade’s perspective on DNA sequencing technology. Nature 470: 198–203.

    Article  CAS  PubMed  Google Scholar 

  • Mardis, E.R., and J.E. Lunshof. 2009. A focus on personal genomics. Personalized Medicine 6: 603–606.

    Article  Google Scholar 

  • Marris, E. 2005. Free genome databases finally defeat Celera. Nature 435: 6.

    Article  CAS  PubMed  Google Scholar 

  • McCarty, C.A., R.L. Chisholm, C.G. Chute, I.J. Kullo, G.P. Jarvik, et al. 2011. The eMERGE network: A consortium of biorepositories linked to electronic medical records data for conducting genomic studies. BMC Medical Genetics 4: 13.

    Article  Google Scholar 

  • McGuire, A.L., M. Basford, L.G. Dressler, S.M. Fullerton, B.A. Koenig, et al. 2011. Ethical and practical challenges of sharing data from genome-wide association studies: The eMERGE consortium experience. Genome Research 21: 1001–1007.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  • McGuire, A.L., T. Caulfield, and M.K. Cho. 2008a. Research ethics and the challenge of whole-genome sequencing. Nature Reviews Genetics 9: 152–156.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  • McGuire, A.L., J.A. Hamilton, R. Lunstroth, L.B. McCullough, and A. Goldman. 2008b. DNA data sharing: Research participants’ perspectives. Genetics in Medicine 10: 46–53.

    Article  PubMed Central  PubMed  Google Scholar 

  • Motluk, A. 2005. Anonymous sperm donor traced on internet. New Scientist 3: 6.

    Google Scholar 

  • National Human Genome Research Institute (NHGRI). 2010. The human genome project completion: Frequently asked questions. US Department of Energy Office Science. http://www.genome.gov/11006943.

  • National Institute of Health (NIH). 2007. Policy for sharing of data obtained in NIH supported or conducted genome-wide association studies (GWAS). Not. NOT-OD-07-088, NIH, Bethesda, MD. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html.

  • Nature. 2001. Human genomes, public and private. Nature 409: 745.

    Google Scholar 

  • Nyholt, D.R., C.E. Yu, and P.M. Visscher. 2009. On Jim Watson’s APOE status: Genetic information is hard to hide. European Journal of Human Genetics 17: 147–149.

    Article  PubMed Central  PubMed  Google Scholar 

  • O’Doherty, K.C., M.M. Burgess, K. Edwards, R.P. Gallagher, A.K. Hawkins, et al. 2011. From consent to institutions: designing adaptive governance for genomic biobanks. Social Science and Medicine 73: 367–374.

    Article  PubMed  Google Scholar 

  • Organisation for Economic Co-operation and Development (OECD). 2007. OECD principles and guidelines for access to research data from public funding. Paris: OECD. http://www.oecd.org/dataoecd/9/61/38500813.pdf.

  • P3G Consortium, G. Church, C. Heeney, N. Hawkins, J. de Vries, et al. 2009. Public access to genome-wide data: five views on balancing research with privacy and protection. PLoS Genetics 5: e1000665.

    Article  PubMed Central  PubMed  Google Scholar 

  • Pearce, N., and A.H. Smith. 2011. Data sharing: not as simple as it seems. Environmental Health 10: 107.

    Article  PubMed Central  PubMed  Google Scholar 

  • Piwowar, H.A. 2011. Who shares? Who doesn’t? Factors associated with openly archiving raw research data. PLoS ONE 7: e18657.

    Article  Google Scholar 

  • Pop, M., and S.L. Salzberg. 2008. Bioinformatics challenges of sequencing technology. Trends in Genetics 24: 142–149.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  • Rodriguez H., M. Snyder, M. Uhl´en, P. Andrews, R. Beavis, et al. 2009. Recommendations from the 2008 international summit on proteomics data release and sharing policy: The Amsterdam principles. Journal of Proteome Research. 8: 3689–3692.

    Google Scholar 

  • Skloot, R. 2010. The immortal life of Henrietta Lacks. London: Macmillan.

    Google Scholar 

  • Tabor, H.K., B.E. Berkman, S.C. Hull, and M.J. Bamshad. 2011. Genomics really gets personal: how exome and whole genome sequencing challenge the ethical framework of human genetics research. American Journal of Medical Genetics Part A 155A: 2916–2924.

    Article  PubMed  Google Scholar 

  • United States Government Printing Office. 1946–1949. Trials of war criminals before the Nuremberg Military Tribunals under Control Council Law No. 10 (NMT). Washington, DC: United States Government Printing Office.

    Google Scholar 

  • Trinidad, S.B., S.M. Fullerton, E.J. Ludman, G.P. Jarvik, E.B. Larson, et al. 2011. Research practice and participant preferences: the growing gulf. Science 331: 287–288.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  • Tutton, R. 2002. Gift relationships in genetics research. Science and Culture 11: 523–542.

    Article  Google Scholar 

  • Van Ness, B. 2008. Genomic research and incidental findings. The Journal of Law, Medicine and Ethics 36: 292–297.

    Article  PubMed Central  PubMed  Google Scholar 

  • Viertler, C., and K. Zatloukal. 2008. Biobanking and biomolecular resources research infrastructure (BBMRI). Implications for pathology. Pathologe 29(Suppl. 2): 210–213.

    Article  PubMed  Google Scholar 

  • Watson, J.D. 1990. The human genome project: past, present, and future. Science 248: 44–49.

    Article  CAS  PubMed  Google Scholar 

  • Wellcome Trust. 2003. Sharing data from large-scale biological research projects: A system of tripartite responsibility. Rep., Wellcome Trust Meet., Fort Lauderdale, (14–15 January 2003), http://www.genome.gov/Pages/Research/WellcomeReport0303.pdf.

  • Wellcome Trust. 2010. Sharing research data to improve public health: Full joint statement by funders of health research. http://www.wellcome.ac.uk/About-us/Policy/Spotlight-issues/Data-sharing/Public-health-and-epidemiology/WTDV030690.htm.

  • Wellcome Trust Case Control Consort. 2007. Genome-wide association study of 14,000 cases of seven common diseases and 3,000 shared controls. Nature 447: 661–678.

    Article  Google Scholar 

  • Winickoff, D.E. 2007. Partnership in UK biobank: A third way for genomic property? The Journal of Law, Medicine and Ethics 35: 440–456.

    Article  PubMed  Google Scholar 

  • Winickoff, D.E., and M.D. Winickoff. 2003. The charitable trust as a model for genomic biobanks. New England Journal of Medicine 349: 1180–1184.

    Article  CAS  PubMed  Google Scholar 

  • Wolf, L.E., and B. Lo. 2004. Untapped potential: IRB guidance for the ethical research use of stored biological materials. IRB 26: 1–8.

    Article  PubMed  Google Scholar 

  • Wolf, S.M., et al. 2008. Managing incidental findings in human subjects research: analysis and recommendations. The Journal of Law Medicine and Ethics 36: 219–248.

    Article  Google Scholar 

  • Wood v. Commissioner of Police for the Metropolis. 2009. EWCA Civ. 414.

    Google Scholar 

  • World Medical Association (WMA). 2008. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, amended in 1975, 1983, 1989, 1996, 2000, 2002, 2004, and 2008. http://www.wma.net/en/30publications/10policies/b3.

  • Zika E., T. Schulte in den Bäumen, J. Kaye, A. Brand, D. Ibarreta. 2008. Sample and data use and protection in biobanking in Europe: legal issues. Pharmacogenomics 9: 773–81.

    Google Scholar 

Download references

Acknowledgments

J.K. is funded under Wellcome Trust Award 096599/2/11/Z. My thanks also go to Jim Duncan for editing the manuscript and to the anonymous reviewer for comments.

Author information

Authors and Affiliations

  1. University of Oxford, Oxford, UK

    Jane Kaye

Authors
  1. Jane Kaye
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Jane Kaye .

Editor information

Editors and Affiliations

  1. Centre for Biomedicine, European Academy Bolzano, Bolzano, Italy

    Deborah Mascalzoni

Rights and permissions

Reprints and permissions

Copyright information

© 2015 Springer Science+Business Media Dordrecht

About this chapter

Cite this chapter

Kaye, J. (2015). The Tension Between Data Sharing and the Protection of Privacy in Genomics Research. In: Mascalzoni, D. (eds) Ethics, Law and Governance of Biobanking. The International Library of Ethics, Law and Technology, vol 14. Springer, Dordrecht. https://doi.org/10.1007/978-94-017-9573-9_8

Download citation

  • DOI: https://doi.org/10.1007/978-94-017-9573-9_8

  • Published:

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-017-9572-2

  • Online ISBN: 978-94-017-9573-9

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation