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Regulating Biobanks: Another Triple Bottom Line

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Comparative Issues in the Governance of Research Biobanks

Abstract

In European societies, where there are clear political and legal commitments to respect human rights, it is axiomatic that the regulatory environment for biobanks—by which I mean public health research facilities, such as UK Biobank—should be compatible with those commitments; in particular, it is essential that the rights of participants are respected. During the start-up period for such biobanks, regulators will be expected to ensure: (i) that both participation and the use of participants’ samples and data are based on free and informed consent; (ii) that the privacy, confidentiality, and fair data processing rights of participants are respected; and (iii) that the proprietary rights (if any) of participants are respected. While the scope and substance of these rights are much debated, it is broadly agreed that the adequacy of the regulatory environment will be judged by reference, so to speak, to this triple bottom line.

In this paper, I will sketch a larger regulatory picture with its own triple bottom line. The larger picture is of a community with rights commitments (a community of rights) for which one of the bottom lines is, indeed, that the rights of its members, including the rights of biobank participants, should be respected. Thus, the early-stage debates about privacy, property, and consent are debates about one of the larger bottom lines as, indeed, are the debates that follow about feedback to participants and third-party access to the collection. In this larger picture, though, there are two other bottom lines: one is that regulators should act as stewards for the agency commons (for the infrastructural conditions that are essential to human life); and the other is that the regulatory environment should not become so reliant on coding, design, and technical fixes that the conditions and context for moral community are compromised. While biobanking for public health purposes might seem to be an unimpeachable act of stewardship, we need to be careful that it does not contribute to the corrosion of the conditions for moral community.

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Notes

  1. 1.

    McHale (2004), Campbell (2006) and Brownsword (2007), p. 11.

  2. 2.

    Black (2005), pp. 1–11.

  3. 3.

    Brownsword and Somsen (2009).

  4. 4.

    Lessig (1999a), Chap. 7; Lessig (1999b), pp. 113, 501, 507–514.

  5. 5.

    Code, at 93–94.

  6. 6.

    Hildebrandt (2008).

  7. 7.

    Hildebrandt and Koops (2010).

  8. 8.

    Gibbons (2007a and 2007b).

  9. 9.

    Ibid, p. 132.

  10. 10.

    UK Biobank Ethics and Governance Council, Review 2008, at 4.

  11. 11.

    Ibid.

  12. 12.

    Op cit, note 9, at 134.

  13. 13.

    UK Biobank Ethics and Governance Framework (version 2.0, July 2006) p. 6, para. I.B.1.

  14. 14.

    Thus, ibid. at p. 12, para. I.C.1, we read: “UK Biobank will maintain strict measures to protect confidentiality, and will ensure that data and samples are (reversibly) anonymised, linked and stored to very high standards of security. The same protection will be extended under contract for any handling or analysis of data or samples by third parties engaged to provide services necessary for developing the resource”.

  15. 15.

    UK Biobank Ethics and Governance Council, Annual Review 2009, at 9.

  16. 16.

    UK Biobank Ethics and Governance Council, Annual Review 2008, p. 13.

  17. 17.

    Brownsword (2009), p. 99; Brownsword (2010), p. 81.

  18. 18.

    It should be emphasized that this test only takes the community as far as recognizing prima facie responsibilities. Even if A is judged to have a prima facie positive obligation in relation to B, there might yet be competing or conflicting rights-based claims to be arbitrated.

  19. 19.

    Compare UK Biobank Ethics and Governance Council, Annual Review 2009, at 9, where the EGC reports that UK Biobank intends “to develop a protocol that incorporates a limited feedback loop for those incidental findings considered to be potentially ‘serious’ (defined in this context as likely to threaten life span, quality of life or major body functions) and which are observed during the imaging visit”.

  20. 20.

    Hodgson (1967).

  21. 21.

    Compare UK Biobank Ethics and Governance Council (2009), at 9: “We discussed the proposal for a strict policy of no feedback whatsoever and found this to be ethically problematic in relation not only to the participant but also the radiographer who might happen to notice an abnormality that they felt morally and professionally compelled to mention to the participant”.

  22. 22.

    Beyleveld and Brownsword (2007).

  23. 23.

    Compare UK Biobank Ethics and Governance Council, Annual Review 2009, Annex A.

  24. 24.

    Frischmann (2005), p. 923.

  25. 25.

    Beyleveld and Brownsword (2009), p. 175.

  26. 26.

    Fisher et al. (2006) and Fisher (2007).

  27. 27.

    Brownsword (2006a), p. 201; Brownsword (2006b), p. 42.

  28. 28.

    “Whose Potbelly is it Anyway?” public lecture, hosted by the Nuffield Council on Bioethics, delivered at the Royal Society, London, April 26, 2010.

  29. 29.

    Thaler and Sunstein (2008).

  30. 30.

    Gewirth (1978, 1996).

  31. 31.

    Norrie (2009), p. 1; Zedner (2009), p. 35.

  32. 32.

    Koops (2009), p. 93.

  33. 33.

    President’s Council on Bioethics, Beyond Therapy (Washington: Dana Press, 2003).

  34. 34.

    Ibid., at pp. 105–106.

  35. 35.

    Ibid., at 106.

  36. 36.

    Bowling et al. (2008), p. 51; Koops (2009).

  37. 37.

    Smith (2000), pp. 147–170.

  38. 38.

    Ibid. Smith is making this important point in the context of automatic ticketing systems that are designed to reduce fare evasion by users of public transport.

  39. 39.

    Brownsword (2008), Chap. 8.

  40. 40.

    Yeung (2008).

References

  • Beyleveld D, Brownsword R (2007) Consent in the law. Oxford Hart Publishing, Oxford

    Google Scholar 

  • Beyleveld D, Brownsword R (2009) Complex Technology, Complex Calculations: Uses and Abuses of Precautionary Reasoning in Law. In: Duwell M, Sollie P (eds) Evaluating new technologies: methodological problems for the ethical assessment of technological developments. Springer, Heidelberg, pp 175–190

    Chapter  Google Scholar 

  • Black J (2005) What is Regulatory Innovation? In: Black J, Lodge M, Thatcher M (eds) Regulatory innovation. Edward Elgar, Cheltenham, pp 1–11

    Google Scholar 

  • Bowling B, Marks A, Murphy C (2008) Crime control technologies: towards an analytical framework and research agenda. In: Brownsword R, Yeung K (eds) Regulating technologies. Legal futures, regulatory frames and technological fixes. Oxford Hart Publishing, Oxford, pp 51–78

    Google Scholar 

  • Brownsword R (2006a) Public health, private right and the common law. Public Health 120:42–50

    Article  Google Scholar 

  • Brownsword R (2006b) Public health, private right: constitution and common law. Med Law Int 7:201–218

    Article  Google Scholar 

  • Brownsword R (2007) Biobank Governance: Property, Privacy and Consent. In: Lenk C, Hoppe N, Andorno R (eds) Ethics and law of intellectual property. Ashgate, Aldershot, pp 11–25

    Google Scholar 

  • Brownsword R (2008) Rights, regulation, and the technological revolution. Oxford University Press, Oxford

    Book  Google Scholar 

  • Brownsword R (2009) Rights, responsibility and stewardship: beyond consent. In: Widdows H, Mullen C (eds) The governance of genetic information: who decides? Cambridge University Press, Cambridge, pp 99–125

    Google Scholar 

  • Brownsword R (2010) The Ancillary-Care Responsibilities of Researchers: Reasonable but not Great Expectations. In: Harrington J (ed) Global health and human rights. Routledge, London, pp 81–101

    Google Scholar 

  • Brownsword R, Han Somsen H (2009) Law, innovation and technology: before we fast forward—a forum for debate. Law Innov Technol 1(1):1–73

    Google Scholar 

  • Campbell AV (2006) The Ethical Challenges of Biobanks: Safeguarding Altruism and Trust. In: McLean SAM (ed) First do no harm. Ashgate, Aldershot, pp 203–214

    Google Scholar 

  • Fisher E (2007) Risk regulation and administrative constitutionalism. Oxford Hart Publishing, Oxford

    Google Scholar 

  • Fisher E et al (2006) Implementing the precautionary principle: perspectives and prospects. Edward Elgar, Cheltenham

    Google Scholar 

  • Frischmann BM (2005) An economic theory of infrastructure and commons management. Minnesota Law Rev 89:917–1030

    Google Scholar 

  • Gewirth A (1978) Reason and morality. University of Chicago Press, Chicago

    Google Scholar 

  • Gewirth A (1996) The community of rights. University of Chicago Press, Chicago

    Google Scholar 

  • Gibbons SMC (2007a) Are UK genetic databases governed adequately? A comparative legal analysis. Legal Stud 27:312–342

    Article  Google Scholar 

  • Gibbons SMC (2007b) Governance of population genetic databases: a comparative analysis of legal regulation in Estonia, Iceland, Sweden and the UK. In: Häyry M, Chadwick R, Árnason V, Árnason G (eds) The ethics and governance of human genetic databases. Cambridge University Press, Cambridge, p 132

    Google Scholar 

  • Hildebrandt M (2008) Legal and technological normativity: more (and less) than twin sisters. Techne 12(3):169–183

    Google Scholar 

  • Hildebrandt M, Koops BJ (2010) The challenges of ambient law and legal protection in the profiling era. Mod Law Rev 73(3):428–460

    Article  Google Scholar 

  • Hodgson DH (1967) Consequences of utilitarianism. Oxford Clarendon Press, Oxford

    Google Scholar 

  • Koops BJ (2009) Technology and the crime society: rethinking legal protection. Law Innov Technol 1(1):93–124

    Google Scholar 

  • Lessig L (1999a) Code and other laws of cyberspace. New York Basic Books, New York

    Google Scholar 

  • Lessig L (1999b) The law of the horse: what cyberlaw might teach. Harv Law Rev 113:501–549

    Article  Google Scholar 

  • McHale JV (2004) Regulating genetic databases: some legal and ethical issues. Med Law Rev 12:70–96

    Article  Google Scholar 

  • Norrie A (2009) Citizenship, Authoritarianism and the Changing Shape of the Criminal Law. In: McSherry B, Norrie A, Bronitt S (eds) Regulating deviance. Oxford Hart Publishing, Oxford, pp 13–34

    Google Scholar 

  • Nuffield Council on Bioethics (2010) Whose potbelly is it anyway? Royal Society, London

    Google Scholar 

  • President’s Council on Bioethics (2003) Beyond therapy. Dana Press, Washington

    Google Scholar 

  • Smith DJ (2000) Changing Situations and Changing People. In: von Hirsch A, Garland D, Wakefield A (eds) Ethical and social perspectives on situational crime prevention. Oxford Hart Publishing, Oxford, pp 147–170

    Google Scholar 

  • Thaler RH, Sunstein CR (2008) Nudge: improving decisions about health, wealth, and happiness. Yale University Press, New Haven

    Google Scholar 

  • UK Biobank Ethics and Governance Framework (version 2.0, 2006)

    Google Scholar 

  • UK Biobank Ethics and Governance Council (2008) Annual review 2008

    Google Scholar 

  • UK Biobank Ethics and Governance Council (2009) Annual review 2009

    Google Scholar 

  • Yeung K (2008) Towards an Understanding of Regulation by Design. In: Brownsword R, Yeung K (eds) Regulating technologies. Oxford Hart Publishing, Oxford, pp 79–108

    Google Scholar 

  • Zedner L (2009) Fixing the future? The pre-emptive turn in criminal justice. In: McSherry, Norrie, Bronitt (eds) Regulating deviance. Oxford Hart Publishing, Oxford, pp 35–58

    Google Scholar 

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Authors and Affiliations

  1. King’s College, London, UK

    Roger Brownsword

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  1. Roger Brownsword
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Correspondence to Roger Brownsword .

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Editors and Affiliations

  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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Brownsword, R. (2013). Regulating Biobanks: Another Triple Bottom Line. 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_3

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