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Legal Challenges and Strategies in the Regulation of Research Biobanking

  • Elisabeth Rynning

Abstract

In this chapter, some of the legal challenges of research biobanking are discussed and illustrated by examples of possible analogies as well some comparative notes on the regulatory strategies adopted in the Nordic countries. Human biological material is compared with biologicalwaste, raw materials, human beings, personal or nonidentifiable health data, and different kinds of public resources. It is concluded that the complex nature of human biobanks would seem to defy any attempt at a simplified regulatory analogy. Even so, it is clear that the application of more sophisticated analogical reasoning will still be valuable in the regulatory process and that policy makers must try to identify an appropriate combination of diverse approaches. While the international nature of biomedical research provides a strong incentive for more harmonised rules, the regulatory process is here further complicated by the plurality of religious, cultural, social and legal traditions, as well as issues of regulatory competence. Nevertheless, some degree of regional or even international consensus could certainly be reached with regard to less controversial areas and issues, and this potential must be further explored. The regulation of research biobanking should be perceived as an ongoing step-by-step process, rather than a problem that will soon be solved once and for all. In the short-term perspective especially, it must be expected that legal restrictions and administrative inconveniences may cause additional costs and delay or even prevent promising research. The long-term aim must be to serve the best interests of the public, by a careful balancing of the freedom of research against other fundamental rights and values.

Keywords

Nordic Country Human Material Legal Challenge Data Protection Directive Research Biobanking 
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.

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References

  1. Annas, G.J. (1999) Waste and Longing – The Legal Status of Placental-Blood Banking, New England Journal of Medicine 340: 1521–1524.PubMedCrossRefGoogle Scholar
  2. Annas, G.J. (1988) Whose Waste Is It Anyway? The Case of John Moore, The Hastings Center Report, Vol. 18, No. 5, pp. 37–39.CrossRefGoogle Scholar
  3. Arnardottir, O.M. et al. (1999) The Icelandic Health Sector Data Base, European Journal of Health Law 6: 307–362.PubMedCrossRefGoogle Scholar
  4. Berg, K. (1983) Ethical Problems Arising from Research Progress in Medical Genetics. In: Berg, K. & Tranøy, K.E (eds.) Research Ethics, Alan R. Liss, New York, pp. 261–275.Google Scholar
  5. Beyleveld, D. & Brownsword, R. (2001) Human Dignity in Bioethics and Biolaw, Oxford Univeristy Press, Oxford.Google Scholar
  6. Burrell, R. (2006) Assisted Reproduction in the Nordic Countries – A Comparative Study of Policies and Regulation, TemaNord 2006:505, Nordic Committee on Bioethics, www.norden.org/pub/sk/showpub.asp?pubnr=2006:505.
  7. Cambon-Thomsen, A. et al. (2007) Trends in Ethical and Legal Frameworks for the Use of Human Biobanks, Eur Respir J 30: 373–382.PubMedCrossRefGoogle Scholar
  8. Elger, B.S. & Caplan, A.L. (2006) Consent and Anonymization in Research Involving Biobanks: Differing Terms and Norms Present Serious Barriers to an International Framework. EMBO Rep 7(7): 661–666.PubMedCrossRefGoogle Scholar
  9. Eriksson, S. (2003) Mapping the Debate on Informed Consent. In: Hansson, M. & Levin, M. (eds.) Biobanks as Resources for Health, Research Program Ethics in Biomedicine, Uppsala University, Uppsala, pp. 165–196.Google Scholar
  10. Frykman, H. & Mörth, U. (2004) Soft Law and Three Notions of Democracy: The Case of the EU. In: Mörth, U. (ed.) Soft Law in Governance and Regulation: An Interdisciplinary Analysis, E. Elgar Publisher, Northampton, MA, pp. 155–179.Google Scholar
  11. Gadd, E. (2005) The Global Significance of the Convention on Human Rights and Biomedicine. In: Gevers, J.K.M., Hondius, E.H. & Hubben, J.H. (eds.) Health Law, Human Rights and the Biomedicine Convention, Martinus Nijhoff Publishers, Boston, MA.Google Scholar
  12. Gertz, R. (2004) Is it ‘Me’ or ‘We’? Genetic Relations and the Meaning of ‘Personal Data’ under the Data Protection Directive. Eur J Health Law 11: 231–244.CrossRefGoogle Scholar
  13. Gevers, S. (2005) Human Tissue Research, with Particular Reference to DNA Biobanking. In: Gevers, J.K.M., Hondius, E.H. & Hubben, J.H. (eds.) Health Law, Human Rights and the Biomedicine Convention, Martinus Nijhoff Publishers, Boston, MA, pp. 231–243.Google Scholar
  14. Greely, H.T. (2007) The Uneasy Ethical and Legal Underpinnings of Large-Scale Genomic Biobanks. Annu Rev Genomics Hum Genet 8: 343–364.PubMedCrossRefGoogle Scholar
  15. Halvorsen, M. (2006) Norsk biobankrett – Rettslig regulering av humant biologisk materiale, Fagbokforlaget, Bergen.Google Scholar
  16. Harmon, S.H.E. (2006) The Recommendation on Research on Biological Materials of Human Origin: Another Brick in the Wall, Eur J Health Law 13: 293–310.PubMedCrossRefGoogle Scholar
  17. Hartlev, M. (2005) Fortrolighed i sundhedsretten – et patientretligt perspektiv, Forlaget Thomson A/S, Copenhagen.Google Scholar
  18. Helgasson, H.H. (2004) Informed Consent for Donating Biosamples in Medical Research – Legal Requirements in Iceland. In: ´Arnason et al. (eds.) Blood and Data. Ethical, Legal and Social Aspects of Human Genetic Databases, University of Iceland Press & Center for Ethics, Reykjavik, pp. 127–134.Google Scholar
  19. Hermerén, G. (1997) Protecting Human Integrity. In: Sorsa, M. & Eyrfjörö, J. (eds.), Human biobanks – Ethical and Social Issues (Nord 1997:9), The Nordic Committee on Bioethics, Copenhagen, pp. 17–36.Google Scholar
  20. Hervey, T.K. & McHale, J.V. (2004) Health Law and the European Union, Cambridge University Press, Cambridge.CrossRefGoogle Scholar
  21. Hondius, F.W. (1997) Protecting Medical and Genetic Data, European J Health Law 4: 361–388.CrossRefGoogle Scholar
  22. Kakuk, P. (2008) Gene Concepts and Genethics: Beyond Exceptionalism, Sci Eng Ethics 14(3): 357–375.PubMedCrossRefGoogle Scholar
  23. Kaye, J. (2006) Do We Need a Uniform Regulatory System for Biobanks Across Europe? Eur J Hum Genet 14: 245–248.PubMedCrossRefGoogle Scholar
  24. Knoppers, B.M. & Laberge, C. (1989), DNA Sampling and Informed Consent, CMAJ, 140: 1023–1028.Google Scholar
  25. Knoppers B.M. & Fecteau, C. (2003), Human Genomic Databases: A Global Public Good? Eur J Health Law 10: 27–41.PubMedCrossRefGoogle Scholar
  26. Laurie, G. (2002) Genetic Privacy – A Challenge to Medico-Legal Norms, Cambridge University Press, Cambridge.CrossRefGoogle Scholar
  27. Legislation on Biotechnology in the Nordic Countries – An overview, TemaNord 2006:506, www.norden.org/pub/ovrigt/ovrigt/uk/TN2006506.pdf.
  28. McNally, E. & Cambon-Thomsen, A. et al. (2004a) 25 Recommendations on the Ethical, Legal and Social Implications of Genetic Testing, European Commission, Brussels.Google Scholar
  29. McNally, E. & Cambon-Thomsen, A. et al. (2004b) Ethical, Legal and Social Aspects of Genetic Testing: Research, Development and Clinical Applications, European Commission, Brussels.Google Scholar
  30. Milunsky, A & Annas G.J. (eds.) (1976) Genetics and the Law, Plenum Press, New York.Google Scholar
  31. Murray, T.H. (1997) Genetic Exceptionalism and ‘Future Diaries’: Is Genetic Information Different from Other Medical Information? In Rothstein, M.A. (ed.), Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era. Yale University Press, New Haven.Google Scholar
  32. Mörth, U. (2004a) Introduction; Conlusions. In: Mörth, U. (ed.) Soft Law in Governance and Regulation: An Interdisciplinary Analysis, E. Elgar Publisher, Northampton, MA.Google Scholar
  33. Nelkin, D. & Andrews, L. (1998) Homo Economicus Commercialization of Body Tissue in the Age of Biotechnology, The Hastings Center Report, Vol. 28, No. 5, pp. 30–39.PubMedCrossRefGoogle Scholar
  34. Nielsen, L. et al. (1996) Health Science Information Banks: Biobanks: Danish Central Scientific- Ethical Committee, Danish Council of Ethics, Danish Medical Research Council, Copenhagen.Google Scholar
  35. Nys, H. (2008) Research on Human Biological Materials and the Council of Europe: Some Unanswered Questions, Overlaps and Empty Boxes. European Journal of Health Law 15: 1–6.PubMedCrossRefGoogle Scholar
  36. Ossorio, P.N. (2007) The Human Genome as Common Heritage: Common Sense or Legal Nonsense? J Law, Med Ethics 35: 425–437.CrossRefGoogle Scholar
  37. Riis, P. (1997) Biobanks Yesterday, Today and Tomorrow:Purposes, Types and Controversies. Human Biobanks – Ethical and Social Issues. In: Sorsa, M. & Eyrfjörö, J. (eds.), Human Biobanks – Ethical and Social Issues (Nord 1997:9), The Nordic Committee on Bioethics, Copenhagen, pp. 37–41.Google Scholar
  38. Romeo Casabona, C.M. (2004) Anonymization and Pseudonymization: Legal Framework at a European Level. In: Beyleveld, D., Townend, D., Rouillé-Mirza, S. &Wright, J. (eds.) The Data Protection Directive and Medical Research Across Europe, Ashgate Publishing, Aldershot, pp. 34–49.Google Scholar
  39. Roucounas, E. (2005) The Biomedicine Convention in Relation to Other International Instruments. In: Gevers, J.K.M., Hondius, E.H. & Hubben, J.H. (eds.) Health Law, Human Rights and the Biomedicine Convention, Martinus Nijhoff Publishers, Boston, MA.Google Scholar
  40. Rouillé-Mirza, S. & Wright, J. Comparative Study on the Implementation and Effect of Directive 95/46/EC on Data Protection in Europe: Medical Research. In: Beyleveld, D. et al. (eds.) The Data Protection Directive and Medical Research Across Europe, Ashgate Publishing, Aldershot, pp. 189–230.Google Scholar
  41. Rynning, E. (2003a), Public Law Aspects on the Use of Biobank Samples – Privacy Versus the Interests of Research. In: Hansson, M. & Levin, M. (eds.) Biobanks as Resources for Health, Research Program Ethics in Biomedicine, Uppsala University, Uppsala, pp. 91–128.Google Scholar
  42. Rynning, E. (2003b) Offentligrä ttslig reglering av biobankerna – en utmaning för lagstiftaren. In: Wolk, S. (ed.), Biobanksrä tt, Studentlitteratur, Lund, pp. 49–175.Google Scholar
  43. Rynning, E. (2004) Processing of Personal Data in Swedish Health Care and Biomedical Research. In: Beyleveld, D. et al. (eds.) Implementation of the Data Protection Directive in Relation to Medical Research in Europe Aldershot: Ashgate Publishing, Aldershot, pp. 381–402.Google Scholar
  44. Rynning, E. (2009) Legal Tools and Strategies for the Regulation of Chimbrids. Taupitz, J. & Weschka, M. (eds.), CHIMBRIDS – Chimeras and Hybrids in Comparative European and International Research, Springer, Berlin, pp. 80–88.Google Scholar
  45. Senden, L. (2005) Soft Law, Self-Regulation and Co-regulation in European law: Where Do They Meet? Electron J Comp Law, 9.1: 23.Google Scholar
  46. Sethe, S. (2004) Cell Line Research with UK Biobank – Why the New British Biobank Is Not Just Another Population Genetic Database. In: ´Arnason, G. et al. (eds.). Blood and Data – Ethical, Legal and Social Aspects of Human Genetic Databases, University of Iceland Press & Center for Ethics, Reykjavik, pp. 313–319.Google Scholar
  47. Sheremeta, L. & Knoppers, B.M. (2007) Beyond the Rhetoric: Population Genetics and Benefit- Sharing. In: Phillips, P.W.B. & Onwuekwe, C.B. (eds.). Accessing and Sharing the Benefits of the Genomics Revolution, Springer, Berlin, pp. 157–182.CrossRefGoogle Scholar
  48. Wendel, L. (2007) Third Parties’ Interests in Population Genetic Databases: Some Comparative Notes Regarding the Law in Estonia, Iceland, Sweden and the UK. In: Häyry, M. et al. (eds.) The Ethics and Governance of Human Genetic Databases – European Perspectives, Cambridge University Press, Cambridge, pp. 108–119.CrossRefGoogle Scholar

Copyright information

© Springer Science + Business Media, LLC 2009

Authors and Affiliations

  • Elisabeth Rynning
    • 1
  1. 1.Department of LawUppsala UniversityUppsalaSweden

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