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Regulating Biobanks: Another Triple Bottom Line

  • Roger BrownswordEmail author
Chapter

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.

Keywords

Regulatory Environment Moral Community Triple Bottom Line Agency Common Governance Council 
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.

References

  1. Beyleveld D, Brownsword R (2007) Consent in the law. Oxford Hart Publishing, OxfordGoogle Scholar
  2. 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 175–190CrossRefGoogle Scholar
  3. Black J (2005) What is Regulatory Innovation? In: Black J, Lodge M, Thatcher M (eds) Regulatory innovation. Edward Elgar, Cheltenham, pp 1–11Google Scholar
  4. 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 51–78Google Scholar
  5. Brownsword R (2006a) Public health, private right and the common law. Public Health 120:42–50CrossRefGoogle Scholar
  6. Brownsword R (2006b) Public health, private right: constitution and common law. Med Law Int 7:201–218CrossRefGoogle Scholar
  7. 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 11–25Google Scholar
  8. Brownsword R (2008) Rights, regulation, and the technological revolution. Oxford University Press, OxfordCrossRefGoogle Scholar
  9. 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 99–125Google Scholar
  10. 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 81–101Google Scholar
  11. Brownsword R, Han Somsen H (2009) Law, innovation and technology: before we fast forward—a forum for debate. Law Innov Technol 1(1):1–73Google Scholar
  12. Campbell AV (2006) The Ethical Challenges of Biobanks: Safeguarding Altruism and Trust. In: McLean SAM (ed) First do no harm. Ashgate, Aldershot, pp 203–214Google Scholar
  13. Fisher E (2007) Risk regulation and administrative constitutionalism. Oxford Hart Publishing, OxfordGoogle Scholar
  14. Fisher E et al (2006) Implementing the precautionary principle: perspectives and prospects. Edward Elgar, CheltenhamGoogle Scholar
  15. Frischmann BM (2005) An economic theory of infrastructure and commons management. Minnesota Law Rev 89:917–1030Google Scholar
  16. Gewirth A (1978) Reason and morality. University of Chicago Press, ChicagoGoogle Scholar
  17. Gewirth A (1996) The community of rights. University of Chicago Press, ChicagoGoogle Scholar
  18. Gibbons SMC (2007a) Are UK genetic databases governed adequately? A comparative legal analysis. Legal Stud 27:312–342CrossRefGoogle Scholar
  19. 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 132Google Scholar
  20. Hildebrandt M (2008) Legal and technological normativity: more (and less) than twin sisters. Techne 12(3):169–183Google Scholar
  21. Hildebrandt M, Koops BJ (2010) The challenges of ambient law and legal protection in the profiling era. Mod Law Rev 73(3):428–460CrossRefGoogle Scholar
  22. Hodgson DH (1967) Consequences of utilitarianism. Oxford Clarendon Press, OxfordGoogle Scholar
  23. Koops BJ (2009) Technology and the crime society: rethinking legal protection. Law Innov Technol 1(1):93–124Google Scholar
  24. Lessig L (1999a) Code and other laws of cyberspace. New York Basic Books, New YorkGoogle Scholar
  25. Lessig L (1999b) The law of the horse: what cyberlaw might teach. Harv Law Rev 113:501–549CrossRefGoogle Scholar
  26. McHale JV (2004) Regulating genetic databases: some legal and ethical issues. Med Law Rev 12:70–96CrossRefGoogle Scholar
  27. 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 13–34Google Scholar
  28. Nuffield Council on Bioethics (2010) Whose potbelly is it anyway? Royal Society, LondonGoogle Scholar
  29. President’s Council on Bioethics (2003) Beyond therapy. Dana Press, WashingtonGoogle Scholar
  30. 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 147–170Google Scholar
  31. Thaler RH, Sunstein CR (2008) Nudge: improving decisions about health, wealth, and happiness. Yale University Press, New HavenGoogle Scholar
  32. UK Biobank Ethics and Governance Framework (version 2.0, 2006)Google Scholar
  33. UK Biobank Ethics and Governance Council (2008) Annual review 2008Google Scholar
  34. UK Biobank Ethics and Governance Council (2009) Annual review 2009Google Scholar
  35. Yeung K (2008) Towards an Understanding of Regulation by Design. In: Brownsword R, Yeung K (eds) Regulating technologies. Oxford Hart Publishing, Oxford, pp 79–108Google Scholar
  36. 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 35–58Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.King’s CollegeLondonUK

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