The Challenges of Achieving Open Source Sharing of Biobank Data

  • Donna M. GitterEmail author


Several recent biomedical research initiatives have sought to make their data freely accessible to others to stimulate innovation. Many of these initiatives have adopted the “open source” model that has achieved prominence in the computing industry. With respect to genomics research, open access models of data release have become common and most large funding bodies now require researchers to deposit their data in centralized repositories. In particular, biobanks, which are organised collections of biological samples and corresponding data, benefit from the implementation of open source principles. Several obstacles loom, however, as barriers to widespread implementation of open source principles in the field of biomedical research. These include the reluctance among researchers to share their data; the challenge of crafting appropriate publication and intellectual property policies; the difficulties in affording informed consent, privacy, and confidentiality to research participants when data is shared so widely; controversy surrounding the issues of commercialization and benefit-sharing; and the complexity of establishing a suitable infrastructure. This article examines each of these and considers an alternative approach, “fair access” biobanks.


Research Participant Supra Note International HapMap Project Fair Access Data Obtain 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



I wish to thank my host Professor Umberto Izzo and the entire Law and Technology Research Group, Department of Legal Sciences at the University of Trento in Italy for inviting me to contribute this work to their May 2010 conference on “Comparative Issues in the Governance of Research Biobanks: Property, Privacy, Intellectual Property, and the Role of Technology.” This work also benefited from the comments of participants at the 2010 International Data Sharing Conference at the University of Oxford, Centre for Health, Law and Emerging Technologies, as well as the 2010 Intellectual Property Scholars Roundtable at the Intellectual Property Law Center, Drake University Law School in Des Moines, Iowa. Professor Robert Bohrer of California Western School of Law in particular contributed valuable suggestions. Thanks are also due to Professor Jason Mazzone of Brooklyn Law School, who invited me to present this work to his intellectual property law seminar. This work originally appeared in Biotechnology Law Report, December 2010, Vol. 29, No. 6:623–635.


  1. UK Biobank (2007) Ethics and governance framework 12–13. Accessed 16 Mar 2010
  2. Boggio A (2008) Transfer of samples and sharing of results: requirements imposed on researchers. In: Elger B et al (eds) Ethical issues in governing biobanks: global perspectives. Ashgate, London, pp 231–236Google Scholar
  3. Bregman-Eschet Y (2006) Genetic databases and biobanks: who controls our genetic privacy? Santa Clara Comput High Technol Law J 23:17–18Google Scholar
  4. Burger J (2009) Symposium. What is owed participants in biotechnology research? Chi-Kent Law Rev 84:5556Google Scholar
  5. Cambon-Thomsen A (2003) Assessing the impact of biobanks. Nat Genet 34:25–26CrossRefGoogle Scholar
  6. Cambon-Thomsen A (2004) The social and ethical issues of post-genomic biobanks. Nat Rev Genet 5:866–873CrossRefGoogle Scholar
  7. Cambon-Thomsen A et al (2003) Biobanks for genomics and genomics for biobanks. Comp Funct Genomics 4:628–629CrossRefGoogle Scholar
  8. Cambon-Thomsen A et al (2007) Trends in ethical and legal frameworks for the use of human biobanks. Eur Respir J 30:373–382CrossRefGoogle Scholar
  9. Caulfield T et al (2008) Research ethics recommendations for whole-genome research: consensus statement. Public Library Sci Biol. Accessed 16 Mar 2010
  10. Coriell Personalized Medicine Collaborative (2008) Consent to participate in a research study 7. Accessed 21Apr 2010
  11. Coriell Personalized Medicine Collaborative (2009) Technical paper. Accessed 21 Apr 2010
  12. Dennis C (2004) Biologists launch open source movement. Nature 431:494CrossRefGoogle Scholar
  13. Elger B, Caplan A (2006) Consent and anonymization in research involving biobanks. Eur Mol Biol Org Rep 7:661–666Google Scholar
  14. Endy D (2005) Foundations for engineering biology. Nature 438:449–453CrossRefGoogle Scholar
  15. European Life Science Infrastructure for Biological Information (2010) ELIXIR: data for life. Accessed 22 Mar 2010
  16. Felch J (2008) DNA profiles blocked from public access. Los Angels Times, August 29, p 31Google Scholar
  17. Feldman R, Nelson K (2008) Open source, open access, and open transfer: market approaches to research bottlenecks. Accessed 16 Mar 2010
  18. Foster M, Sharp R (2007) Share and share slike. Nat Rev Gen 8:633–635CrossRefGoogle Scholar
  19. Gibbons S (2009) Regulating biobanks: a twelve-point typological tool. Med Law Rev 17:313–346CrossRefGoogle Scholar
  20. Gitter D (2004) Ownership of human tissue: a proposal for federal recognition of human research participants’ property rights in their biological material. Wash & Lee Law Rev 61:257–298Google Scholar
  21. Gitter D (2007) Resolving the open source paradox in biotechnology: a proposal for a revised open source policy for publicly funded genomic databases. Hous Law Rev 43:1475–1521Google Scholar
  22. Haddow G et al (2007) Tackling community concerns about commercialization and genetic research: a modest interdisciplinary proposal. Soc Sci Med 64:272–274CrossRefGoogle Scholar
  23. Hernán M, Wilcox A (2009) Epidemiology, data sharing, and the challenge of scientific replication. Epidemiology 20:167–168CrossRefGoogle Scholar
  24. Homer N et al (2008) Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays. Public Library Sci Genet e1000167. Accessed 16 Mar 2010
  25. Hope J (2004) Open source biotechnology. Accessed 16 Mar 2010
  26. Hope J (2008) Biobazaar: the open source revolution and biotechnology. Harvard University Press, CambridgeGoogle Scholar
  27. Human Genome Project, US Department of Energy Office of Science (1996) Summary of principles agreed at the first international strategy meeting on human genome sequencing. Accessed 16 Mar 2010
  28. Workshop on Ethics and Governance in Biobanking (2009) Accessed 21 Mar 2010
  29. Lerner J, Tirole J (2005) The economics of technology sharing: open source and beyond. J Econ Perspect 19:99–120CrossRefGoogle Scholar
  30. Lin Z et al (2004) Genomic research and human subject privacy. Science 305:183CrossRefGoogle Scholar
  31. Lowrance W (2006) Access to collections of data and materials for health research. Accessed 16 Mar 2010
  32. Lowrance W, Collins F (2007) Identifiability in genomic research. Science 317:600–602CrossRefGoogle Scholar
  33. Lunshof J et al (2008) From genetic privacy to open consent. Nat Rev Genet 9:406–408CrossRefGoogle Scholar
  34. Malin B et al (2010) Technical and policy approaches to balancing patient privacy and data sharing in clinical and translational research. J Invest Med 58:11–17Google Scholar
  35. Maurer S et al (2004) Finding cures for tropical disease: is open source an answer? PLoS Med 1:e56CrossRefGoogle Scholar
  36. National Human Genome Research Institute, National Institutes of Health (2003) Reaffirmation and extension of NHGRI rapid data release policies: large-scale sequencing and other community resource projects. Accessed 16 Mar 2010
  37. National Institutes of Health (2003) Final NIH statement on sharing research data. Accessed 16 Mar 2010
  38. National Institutes of Health (2007) Policy for sharing of data obtained in NIH supported or conducted genome-wide association studies. Accessed 21 Mar 2010
  39. National Institutes of Health (2007) NIH points to consider for IRBs and institutions in their review of data submission plans for institutional certifications under NIH’s policy for sharing of data obtained in NIH supported or conducted genome-wide association studies (GWAS) 4–7. Accessed 10 Mar 2010
  40. National Institutes of Health (2008) Modifications to genome-wide association studies (GWAS). Data Access 1. Accessed 16 Mar 2010
  41. National Institutes of Health (2008) Policy for sharing of data obtained in NIH supported or conducted genome-wide association studies (GWAS). Accessed 16 Mar 2010
  42. Nature Opinion Forum (2009) Prepublication data sharing: the Toronto statement. Accessed 21 Mar 2010
  43. Nelson B (2009) Empty archives. Nature 461:160–163CrossRefGoogle Scholar
  44. Post W (2007) Challenges of an epidemiologist working in genomics. In: Seminar on genome-wide association studies for the rest of us: adding genome-wide association to population studies. Accessed 16 Mar 2010
  45. Rai A (1999) Regulating scientific research: intellectual property rights and the norms of science. Northwestern Univ Law Rev 77:95–96Google Scholar
  46. Raymond E (2002) The cathedral and the Bazaar, at release early, release often. Accessed 16 Mar 2010
  47. Reichman H, Uhlir P (2003) The public domain: a contractually reconstructed research commons for scientific data in a highly protectionist intellectual property environment. Law Contemp Prob 66:315–322Google Scholar
  48. Samet J (2009) Data: to share or not to share? Epidemiology 20:172–174CrossRefGoogle Scholar
  49. Schofield P et al (2009) Post-publication sharing of data and tools. Nature 461:171–173CrossRefGoogle Scholar
  50. Simon B (2009) How to get a fair share: IP policies for publicly supported biobanks. Stanford J Law Sci Policy 65–79Google Scholar
  51. Singleton A (2007) Professional challenges and rewards of open data sharing. In: Seminar on genome-wide association studies for the rest of us: adding genome-wide association to population studies. Accessed 16 Mar 2010
  52. Swede H et al (2007) National population-based biobanks for genetic research. Genet Med 9:141–145CrossRefGoogle Scholar
  53. Terry S et al (2007) Advocacy groups as research organizations: the PXE international example. Nat Rev Genet 8:157–164CrossRefGoogle Scholar
  54. The GAIN Collaborative Research Group (2007) New models of collaboration in genome-wide association studies: the genetic association information network. Nat Genet 39:1045–1050CrossRefGoogle Scholar
  55. The International HapMap Consortium (2003) The International HapMap Project. Nature 426:789, 793CrossRefGoogle Scholar
  56. The National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research (1979) The Belmont report: ethical principles and guidelines for the protection of human subjects of research. Accessed 16 Mar 2010
  57. Tomasson M (2009) Legal, ethical, and conceptual bottlenecks to the development of useful genomic tests. Ann Health Law 18:231–247Google Scholar
  58. Wade N (2009) A genetics company fails, its research too complex. New York Times, November 18, p B2Google Scholar
  59. World Medical Association (1997) Declaration of Helsinki: recommendations guiding physicians in biomedical research involving human subjects. J Am Med Assoc 277:925–926CrossRefGoogle Scholar
  60. Yuille M et al (2009) The UK DNA banking network: a “fair access” biobank. Cell Tissue Bank. Accessed 16 Mar 2010

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.Faculty of LawBaruch CollegeNew YorkUSA

Personalised recommendations