Managing access to biobanks: How can we reconcile individual privacy and public interests in genetic research?

Medical Law International

Volumn 10, Issue 4, 2010, Pages 315-337

  Laurie, Graeme ^a   Mallia, Pierre ^b   Frenkel, David A ^c   Krajewska, Atina ^d   Moniz, Helena ^e   Nordal, Salvor ^f   Pitz, Claudia ^g   Sandor, Judit ^h  

^a UNIVERSITY OF EDINBURGH   (United Kingdom)

^b Joe Louis Grech Centre for Bioethics Organisation   (Malta)

^c BEN GURION UNIVERSITY OF THE NEGEV   (Israel)

^d UNIVERSITY OF EXETER   (United Kingdom)

^e UNIVERSITY OF COIMBRA   (Portugal)

^f UNIVERSITY OF ICELAND   (Iceland)

^g MAASTRICHT UNIVERSITY   (Netherlands)

^h CENTRAL EUROPEAN UNIVERSITY   (Hungary)

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; BIOBANK; EXPECTATION; GENETIC PRIVACY; GENETICS; HEALTH CARE FACILITY; HUMAN; INDIVIDUALIZATION; MEDICAL RESEARCH; PUBLISHING; REVIEW; TRUST;

EID: 79951802866     PISSN: 09685332     EISSN: None     Source Type: Journal    
DOI: 10.1177/096853321001000404     Document Type: Review

References (69)

1. http://www.privileged.group.shef.ac.uk/ [Last accessed 23 July 2010]
2. See also D Townend, MJ Taylor, J Wright and D Wickins-Drazilova, 'Privacy and Access: Privacy Interests in Biobanking: A Preliminary View on a European Perspective,' in J Kaye and M Stranger (eds), Principles and Practice in Biobank Governance (Ashgate, 2009), pp. 137-160.
3. Anita Allen identifies these four dimensions of genetic privacy in her paper 'Genetic Privacy: Emerging Concepts and Values' in MA Rothstein (ed), Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era, (Yale University Press, 1997) There are many more accounts of privacy and recently several privacy scholars have argued that privacy is a cluster concept.
4. See for instance and Judith Wagner de Cew In Pursuit of Privacy, (Ithaca and London: Cornell University Press, 1997).
5. Beate Rössler, The Value of Privacy, (Cambridge, Polity Press 2005).
6. See, for example, R Hardcastle, Law and the Human Body: Property rights, Ownership and Control (Oxford, Hart Publishing, 2007)
7. and D Dickenson, Property in the Body: Feminist Perspectives (Cambridge, Cambridge University Press, 2007).
8. HT Tavani, 'Genomic research and data-mining technology: Implications for personal privacy and informed consent' (2004) 6 Ethics and Informational Technology 15-28.
9. Pretty v United Kingdom (2002) 35 EHRR 1.
10. Organization for Economic Cooperation and Development, OECD Guidelines on Human Biobanks and Genetic Research Databases (2009), Annotations, para 63.
11. AL Caplan, 'What No One Knows Cannot Hurt You: The Limits of Informed Consent in the Emerging World of Biobanking' in JH Solbakk, S Holm and B Hofmann (eds) The Ethics of Research Biobanking (Springer, 2009).
12. The Dutch Code for Proper Secondary Use of Human Tissue of the Dutch Federation of Biomedical Scientific Societies allows secondary use of coded biological material if there is no objection from the donor, provided that the system of no objection is based on sufficient information and a low threshold of objection. Such use of tissue without consent must also serve the general interest of obtaining new scientific results, thus cannot have purely commercial purpose.
13. BS Elger and AL Caplan, 'Consent and anonymization in research involving biobanks: Differing terms and norms present serious barriers to an international framework' (2006) 7(7) EMBO Reports 661-666. (Pubitemid 43986258)
14. On the difficulties of being clear about what 'anonymisation' might mean it its various forms, see BM Knoppers and M Saginur, 'The Babel of genetic data terminology' (2005) 23(8) Nature Biotechnology 925-7.
15. A Boggio, 'Informing participants about research results' in B Elger, N Biller-Andorno, A Mauron, and A Capron (eds.), Ethical and Regulatory Aspects of Human Genetic Databases (Ashgate 2008),
16. C Johnston and J Kaye, 'Does the UK Biobank have a legal obligation to feedback individual findings to participants?' (2004) 12(3) Medical Law Review 239-267,
17. BM Knoppers and L Kharaboyan, '"Deconstructing" biobank communication of results' (2009) 6(3) SCRlPTed 677-684,
18. and compare F Miller et al, 'Duty to disclose what? Querying the putative obligation to return research results to participants' (2008) 34 Journal of Medical Ethics 210-213.
19. The European Court of Human Rights has confirmed that genetic samples as also 'personal data' for the purposes of the ECHR and its interpretation of the European Data Protection Directive, see S and Marper v United Kingdom (2009) 48 EHRR 50.
20. M Häyry and T Takala, 'American principles, European values and the mezzanine rules of ethical genetic databanking', in M Häyry, R Chadwick, V Árnason and G Arnason (eds.) The Ethics and Governance of Human Genetic Databases (Cambridge University Press, 2007), p. 21.
21. The public interest is different from the interests of the public or communities or groups, large or small, which are part of the public. The interests of such groups are more likely to infringe individual rights to privacy, confidentiality, and dignity.
22. M Powers, 'Privacy and the Control of Genetic Information' in MS Frankel and AS Teich (eds.), The Genetic Frontier: Ethics, Law and Policy (1994), American Association for the Advancement of Science, Washington, DC, p. 82
23. and G Laurie, Genetic Privacy, A Challenge to Medico-Legal Norms (Cambridge University Press, 2002), p. 279.
24. RE Ashcroft, Ethical, Legal and Social Issues Facing the West London Database Project: A Review of the Literature (2001) NHS Executive London Regular Office Research and Development Office, London, p. 5.
25. S. and Marper v The United Kingdom (2009), n 12 above.
26. B Godard, J Marshall, C Laberge and BM Knoppers, 'Strategies for consulting with the community: The cases of four large-scale genetic databases' (2004) 10 Science and Engineering Ethics 457-477, p. 461.
27. We acknowledge the very wide diversity of biobanks that exists and in particular the important distinction between banks concerned with particular diseases and those which are established as a general research resource.
28. See generally this Special Issue, P O'Leary and RL Zimmern, 'Genes for Health' (2010) Public Health Genomics, Issue 13(4).
29. G Laurie, Genetic Privacy, supra note 15, at p. 279.
30. Nevertheless, we should be very careful when we speak of collective interests. Such interests may lead us to interests of the public or groups in society, especially in non-liberal communities, who are willing to stigmatise groups, either because of their origin, race and ethnicity, or because of their culture, behavioural preferences and views. Hence we should try to limit the meaning of Public Interest in order to safeguard the individual rights to privacy and confidentiality. It is important to guarantee that people will not be discriminated on the basis of their genetic profile and one's right to full medical insurance will not be lessened.
31. S Harmon, 'A (New) Ethic for Global Health Policy' (2006) 14(4) Health Care Analysis 215-236. (Pubitemid 44944787)
32. Cf. J Schwarze, European Administrative Law, Revised 1st Ed. (Sweet & Maxwell, London, 2006);
33. W Wade & Ch Forsyth, Administrative Law, 8th ed. (Oxford University Press, 2002), p. 328;
34. R. v International Board of Agriculture Produce ex p. E.D. & F. Man (sugar) Ltd. [1986] 2 All E.R. 115;
35. O Koch, Der Grundsatz der Verhältnismäßigkeit in der Rechtsprechung des Gerichtshofs der Europäische Gemeinschaften (2003) (Duncker & Humblot, 2003), p.199 et seq.;
36. JH Jans, 'Proportionality revisited', (2000) 27(3) Legal Issues of European Integration 239-265
37. and FG Jacobs, 'Recent Developments in the Principle of Proportionality in European Community Law' in E Ellis (ed.) The Principle of Proportionality in the Laws of Europe (Hart Legal Publishers, 1999), pp. 1-22.
38. Eurobarometer results show relatively high levels of support for gene banking to faciliate research, especially in a number of Eastern European countries, with less than average support in the southern European countries.
39. D Schroeder, 'Benefit sharing: it's time for a definition' (2007) 33 J Med Ethics 205-209.
40. Act 2008-06-20 no. 44: The Act on Medical and Health Research Act with few exceptions replaced the Personal Data Act, the Personal Health Data Filing System Act, and the Biobank Act in relation to medical and health research.
41. In the field of human genetic research, HUGO'S 1996 Statement on the Principled Conduct of Genetic Research was a pioneer. This was later developed more fully into the HUGO Statement on Benefit Sharing (2000).
42. UNESCO Universal Declaration on Bioethics and Human Rights. 2005, available at: http://www.unesco.org/new/en/social-and-human-sciences/themes/ bioethics/ bioethics-and-human-rights/ [Last accessed 23 July 2010]
43. OECD Guidelines for Human Biobanks and Genetic Research Databases (2009) setting out principles and best practices.
44. The OECD Guidelines for the Licensing of Genetic Inventions (2006) provide guidance so as to ensure that licensing and transferring agreements as well as joint development activities are carried out in a balanced manner and are based on economically rational practices that help eliminate high transaction costs and that serve the interests of society.
45. And similarly, Article 15 of International Covenant on Economic, Social and Cultural Rights (1966).
46. S Wilson, 'Population Biobanks and Social Justice: Commercial or Communitarian Models?' (2004) 1(2) TRAMES 80-89.
47. G Haddow, G Laurie, S Cunningham-Burley and KG Hunter 'Tackling Community Concerns about Commercialisation and Genetic Research: A Modest Interdisciplinary Proposal' (2007) 64 Social Science & Medicine 272.
48. Conference of the Parties to the Convention ob Biological Diversity at its sixth meeting, held in the Hague in April 2002 adopted the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising Out of Their Utilization.
49. In Norway the recent Act on Medical and Health Research recognises a legitimate interest for access by researchers to data and human biological materials; it creates a legal obligation to share biological material with researchers from outside the responsible institution.
50. BM Knoppers, Ma'n H Abdul-Rahman and K Bédard, 'Genomic databases and international collaboration' (2007) 18 King's Law Journal 291-312.
51. Italian National Bioethics Committee 'Biobanks and Research on Human Biological Material' (2006) NBC p.6, available at http://www.governo.it/ bioetica/ eng/pdf/Biobanche-9-giugno-2006.pdf [Last accessed 23 July 2010]
52. The Indigenous People Basic Law of Taiwan, Article 21, contains a requirement that academic research in the area of indigenous people shall consult with the indigenous people and obtain their consent to participation. The indigenous people could share related benefits.
53. G Laurie and K Hunter, 'Benefit-sharing and Public Trust in Genetic Research' in G Árnason, S Nordal and V Árnason (eds.)., Blood and Data (University of Iceland Press, 2004), 323-331.
54. Homer et al, 'Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays' (2008) Public Library of Science Genetics J 4:e1000167.
55. See A Webster et al, 'Public attitudes to third party access and benefit sharing: their application to UK Biobank (June 2008).
56. The Ethics and Governance Framework is available here: http://www.ukbiobank. ac.uk/ethics/egf.php [Last accessed 23 July 2010].
57. DA Jones and C MacKellar, 'Consent for biobank tissue in somatic-cell nuclear transfer' (2009) 374 Lancet 861-3
58. and G Laurie, 'Role of the UK Biobank Ethics and Governance Council' (2009) 374 Lancet 1676.
59. UK Biobank Protoctol, p. 14, available here: http://www.ukbiobank.ac.uk/ docs/ UKBProtocolfinal.pdf [Last accessed 23 July 2010]
60. The three-yearly Eurobarometer reports on Europeans and Biotechnology indicate that trust in this field is slowly growing, with the exception of GM products.
61. For discussion of limitation of traditional approaches see C Heeney et al, 'Assessing the privacy risks of data sharing in genomics' (2010) Public Health Genomics, available in e-publication format ahead of print here: http://content. karger.com/ProdukteDB/produkte.asp?Aktion= JournalHome&ProduktNr=224224 [Last accessed 23 July 2010]
62. See Ruyter et al, 'From Research Exemption to Research Norm: Recognising an Alternative to Consent for Large Scale Biobank Research' in this issue.
63. For a discussion of possible engagement methods relating to biobanks see UK Biobank Ethics and Governance Council, 'Workshop report: Involving publics in biobank research and governance' (2010).
64. See further M Richards, A Hunt and G Laurie, 'UK Biobank Ethics and Governance Council: An Exercise in Added Value' in J Kaye and M Stranger (eds), Principles and Practice in Biobank Governance (Ashgate, 2009).
65. DE Winickoff, 'Partnership in UK Biobank: A third way for genomic property?' (2007) 35(3) Journal of Law, Medicine and Ethics, 440-456.
66. Compare KG Hunter and G Laurie, 'Involving Publics in Biobank Governance: Moving Beyond Existing Approaches', in H Widdows and C Mullen (eds), The Govenance of Genetic Information: Who Decides? (Cambridge University Press, 2009).
67. For comment on legal aspects see G Fobelets and H Nys, 'Evolution in Research Biobanks and its Legal Consequences' in K Dierickx and P Borry (eds), New Challenges for Biobanks: Ethics, Law and Governance (Insentia, 2009).
68. J Kaye, 'Biobanking Networks: What are the Governance Challenges?' in J Kaye and M Stranger (eds), Principles and Practice in Biobank Governance (Ashgate, 2009), pp. 201-213.
69. We do not address issues here such as the nature and appropriateness of the broad consent model because this is beyond the remit of this current article.