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Comparative Issues in the Governance of Research Biobanks pp 105–130Cite as

Should Privacy Be Abolished in Genetics and Biobanking?

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Abstract

In this paper, after a short outline of current main features of biobanking, first the disenchantment on privacy and informed consent in the field is presented and discussed as a reaction to the recognition of full (individual) rights even to each piece of biological materials and/or genetic information. Secondly, the real interests at stake (when biological materials and genetic information are involved) are clarified: is human genome really/exclusively human? What are the boundaries of human family and those of biological group? What does biological group encompass in scientific terms and legal terms? Under what conditions and to what extent does the individual compass interact with those of other family members and with the biological group as a whole? Finally, both the human individual and the biological group compass are conceptualized as legal artefacts, whose definitions are the responsibility of lawmakers and individuals and not of scientists, even if lawmakers and individuals should act being fully aware of the latest scientific findings and views.

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Notes

  1. 1.

    See Study on the Economic Benefits of Privacy Enhancing Technologies (PETs). Final Report to the European Commission (2010) and also UNESCO International Bioethics Committee. DRAFT International Declaration on human genetic data, Addendum 2, 8.10. 2003: “Human genetic data have a special status. Due consideration should be given and where appropriate special protection should be afforded to human genetic data and to biological samples”.

  2. 2.

    Among many others, a list of definitions is available at http://www.privileged.group.shef.ac.uk/. See also Article 29 Data Protection Working Party (2009).

  3. 3.

    European Commission, Brussels, 4.11.2010, com(2010) 609 final, Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions, A comprehensive approach on personal data protection in the European Union.

  4. 4.

    “Human biobanks and genetic research databases, which bring together and allow the sharing of human biological material and information derived from its analysis, are a key element of the scientific infrastructure underpinning such research” (OECD 2009).

  5. 5.

    Elger and Caplan (2006).

  6. 6.

    The Project (2007–2009) was coordinated by Mark Taylor (Sheffield Institute of Biotechnological Law and Ethics, School of Law, University of Sheffield) and David Townend (Faculty of Health, Medicine and Life Sciences, Department of Health, Ethics & Society, Maastricht University) and was looking to determine the ethical and legal interests in privacy and data protection for research involving the use of genetic databases and biobanks. Please find the list at http://www.privileged.group.shef.ac.uk/. Accessed 30 October 2010.

  7. 7.

    According to the Estonian Human Genes Research Act, 2000, as reported at http://www.privileged.group.shef.ac.uk/. Accessed 30 October 2010.

  8. 8.

    Cambon-Thomsen et al. (2007).

  9. 9.

    Elger and Caplan (2006).

  10. 10.

    Nationaler Ethikrat defines biobanks as collections of samples of human body substances (e.g. tissue, blood, DNA), which are electronically linked to personal data and in particular to health information on the donors (Nationaler Ethikrat 2004).

  11. 11.

    “In response to a critical and growing shortage of high-quality, well-documented human biospecimens for cancer research, the National Cancer Institute is developing a national, standardized human biospecimen resource called the cancer Human Biobank (caHUB). Currently, no centralized, standardized infrastructure of this type exists in the United States. caHUB will serve as a continuous and reliable source of high-quality human biospecimens and associated data for the broader cancer community, including basic and clinical researchers and the biotechnology and pharmaceutical industries that rely on human biospecimens for cancer diagnostics and drug development”. http://biospecimens.cancer.gov/cahub/default.asp. Accessed 30 October 2010.

  12. 12.

    Zika et al. (2010).

  13. 13.

    The Institute for Prospective Technological Studies (IPTS) of the European Commission’s Joint Research Centre, in collaboration with the European Science and Technology Observatory (ESTO), launched the following study: Zika et al. (2010). See also Scaffardi (2008).

  14. 14.

    See, e.g., Guidelines for human biobanks, genetic research databases and associated data, prepared by the Office of Population Health Genomics Public Health Division, Government of West Australia, February 2010.

  15. 15.

    UK Biobank (2005). The drafters take some precautions on this very crucial point and say: “It is likely that UK Biobank will take steps to resist access for police or forensic use, in particular by seeking to be represented in all court applications for access in order to defend participants’ trust and public confidence in UK Biobank” (p. 5). The problem is if sample givers are informed about this possibility. In its latest version, the policy seems to be less restrictive “Access to the resource by the police or other law enforcement agencies will be acceded to only under court order, and UK Biobank will resist such access vigorously in all circumstances”, UK Biobank (2007).

  16. 16.

    The opinion Biobanks for research was published in 2004 by the German National Ethics Council (chair: Prof. Spiros Simitis), www.ethikrat.org, pp. 98–99.

  17. 17.

    Such as International Declaration on Human Genetic Data (16 October 2003) and Recommendation of the Council of Europe Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin (adopted 15 March 2006).

  18. 18.

    See Italian National Bioethics Committee (2006). Opinion of the NBC on a Recommendation of the Council of Europe and on a document of the National Committee for Biosecurity and Biotechnology (2006).

  19. 19.

    Office of Population Health Genomics, Public Health Division, Guidelines for human biobanks, genetic research databases and associated data (February 2010), p. iii, at http://www.genomics.health.wa.gov.au/publications/docs/guidelines_for_human_biobanks.pdf.

  20. 20.

    German Ethics Council (2010).

  21. 21.

    There are discussions at present as to whether the Swedish Biobank Act should be amended and the possibilities of access for criminal investigations by the police should be extended. Swedish Kommittédirektiv (2008).

  22. 22.

    Singer (2010).

  23. 23.

    Europeans and biotechnology in 2010. Winds of change? A report to the European Commission’s Directorate-General for Research by Gaskell et al. (October 2010), available at http://ec.europa.eu/research/science-society/document_library/pdf_06/europeans-biotechnology-in-2010_en.pdf. Special attention is reserved to Biobanks. However, the results seem to be not so significant given that only 17 % of interviewed people had a minimum idea of what biobanks are (p. 60).

  24. 24.

    Council of Europe. Committee of Ministers, Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin (Adopted by the Committee of Ministers on 15 March 2006), at https://wcd.coe.int/ViewDoc.jsp?id=977859 (last visited 22 November 2010). Recently, the Italian legislator introduced a new restrictive regulation that forbids any use of any “human material” without a previous specific authorisation (Art. 170 ter, D.Lgs. n. 131/2010, containing integrations to the Codice della Proprietà Industriale, C.P.I., Gazzetta Ufficiale n. 192, 18 August 2010).

  25. 25.

    Lunshof et al. (2008).

  26. 26.

    Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes. Strasbourg, 27 November 2008, at http://conventions.coe.int/Treaty/EN/Treaties/html/203.htm. Accessed 24 October 2010.

  27. 27.

    Harris (2009). See also Saniotis (2007).

  28. 28.

    De et al. (2009). I have the pleasure to thank Prof. Carlo Alberto Redi (University of Pavia, I) for helping me in giving an accurate description of this point.

  29. 29.

    The American Heritage Dictionary of the English Language, Fourth Edition copyright 2000.

  30. 30.

    In the Preamble, Articles 7, 8 and 18, and the all Chapter VI (articles 13–15) are dedicated to “Tests for the benefit of family members”.

  31. 31.

    Article 29 Data Protection Working Party (2004).

  32. 32.

    Knoppers and Saginur (2005).

  33. 33.

    Working Group, cit., p. 8.

  34. 34.

    I am deeply in debt to Prof. Francesco Cucca (University of Sassari, I) who generously and kindly provided me accurate and precious information on the scientific grounds of the issues this paragraph deals with.

  35. 35.

    Società Italiana di Genetica Umana (2010).

  36. 36.

    http://www.hugo-international.org/img/dna_1998.pdf. Accessed 22 November 2010.

  37. 37.

    http://conventions.coe.int/Treaty/EN/Reports/Html/203.htm. Accessed 22 November 2010.

  38. 38.

    http://portal.unesco.org/en/ev.php-URL_ID=13177&URL_DO=DO_TOPIC&URL_SECTION=201.html. Accessed 22 November 2010.

  39. 39.

    Galton (1869), p. 373.

  40. 40.

    See Lunshof et al. (2008).

  41. 41.

    Working Group, op. cit., p.8.

  42. 42.

    See above the conclusions of paragraph 4.6.

  43. 43.

    Macilotti (2008).

  44. 44.

    Black’s Law Dictionary (6th ed. 1990).

  45. 45.

    United States v. Causby, 328 U.S. 256 (1946).

  46. 46.

    Among many, see http://www.oyez.org/cases/1940-1949/1945/1945_630.

  47. 47.

    Nuremberg Code: “… [information on] the effects upon his health or person which may possibly come from his participation in the experiment. […] The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury”.

  48. 48.

    Art. 3 Charter of Fundamental Rights of the European Union: http://www.europarl.europa.eu/charter/pdf/text_en.pdf.

  49. 49.

    Santosuosso et al. (2007) and Santosuosso and Bottalico (2009).

  50. 50.

    See at http://www.europarl.europa.eu/charter/default_en.htm.

  51. 51.

    Lunshof et al. (2008).

  52. 52.

    Kelsen (1945), Part One, Chapter IX, A-B, pp. 93–95.

  53. 53.

    Mill (1859), Chapter I.

  54. 54.

    Of course, this does not solve all the problems, because the condition of full age, and not forced or deceived person is not always possible and we have to decide how to deal with incompetent people. However, this is a not new problem and it is well known in all patient autonomy literature.

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  1. Interdepartmental Research Centre, European Centre for Law, Science and New Technologies (ECLT), University of Pavia, Pavia, Italy

    Amedeo Santosuosso

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  1. University of Trento, via Verdi 73, Trento, 38122, Italy

    Giovanni Pascuzzi

  2. , Faculty of Law, University of Trento, Via Verdi 53, Trento, 38122, Italy

    Umberto Izzo

  3. University of Trento, Via Verdi 53, Trento, 38122, Italy

    Matteo Macilotti

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Santosuosso, A. (2013). Should Privacy Be Abolished in Genetics and Biobanking?. In: Pascuzzi, G., Izzo, U., Macilotti, M. (eds) Comparative Issues in the Governance of Research Biobanks. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-33116-9_7

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