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Reflexive governance in biobanking: on the value of policy led approaches and the need to recognise the limits of law

Abstract

Although a few jurisdictions around the world have legislated in response to the phenomenon of biobanking, the far more common response has been policy led with funders and other stakeholders initiating multi-level policy initiatives to guide biobanking practice. An example of this is UK Biobank which has developed and operates according to an Ethics and Governance Framework. Such an instrument has no basis in law and yet it has played a crucial role in the set up and ongoing management of the resource. It will continue to do so, as related policies emerge, such as access and intellectual property policies. Numerous biobanking initiatives have similar high-level policy documents that guide decisions and practice. These are often framed as a commitment to participants, researchers and society more broadly and invoke notions such as the public good and the public interest. As such, they serve as a benchmark against which to measure a biobank’s performance. Moreover, policies become an important means by which biobankers are held accountable. This article critically analyses this policy-driven phenomenon asking how effectively policy—often as an alternative to law—serves to police and to promote biobanking. It argues that a policy of reflexive governance—defined and developed herein—can best meet the challenges faced by many biobanks and without the need for recourse to law.

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References

  1. Academy of Medical Sciences (2011) A new pathway for regulation and governance of health research. http://www.acmedsci.ac.uk/p99puid209.html

  2. Andrews L (2001) A conceptual framework for genetic policy: comparing the medical, public health and fundamental rights models. Wash Univ Law Q 79:221–285

  3. Ashcroft RE (2003) The ethics and governance of medical research: what does regulation have to do with morality? New Rev Bioethics 1(1):41–58

  4. UK Biobank (2011) www.ukbiobank.ac.uk. Accessed 25 Apr 2011

  5. Biobanking and Biomolecular Resources Research Infrastructure (BBMRI). www.bbmri.eu. Last visited 25 April 2011

  6. Collingridge D (1982) The social control of technology. St Martin’s Press, London

  7. Cutter AM, Wilson S, Chadwick R (2004) Balancing powers: examining models of biobank governance. J Intern Biotech Law 1(5):187–192

  8. Fullerton SM, Anderson NR, Guzauskas G, Freeman D, Fryer-Edwards K (2010) Meeting the governance challenges of next-generation biorepository research. Sci Transl Med 2:15cm3

  9. Gertz R (2004) An analysis of the Icelandic Supreme Court judgement on the Health Sector Database Act. SCRIPTed 1(2):241–258

  10. Gibbons SMC (2007) Are UK genetic databases governed adequately? Leg Stud 27(2):312–342

  11. Gottweis H, Lauss G (2010) Biobank governance in the post-genomic age. Pers Med 7(2):187–195

  12. Gottweis H, Zatioukal K (2007) Biobank governance: trends and perspectives. Pathobiology 74(4):206–211

  13. Guston DH (2008) Innovation policy: not just jumbo shrimp. Nature 454:940–941

  14. Haddow G, Cunningham-Burley S, Murray L (2011) Can the governance of a population genetic data bank effect recruitment? Evidence from the public consultation of Generation Scotland. Public Underst Sci 20(1):117–129

  15. Häyry M, Takala T (2007) Bioethical analysis of the results: how well do laws and regulations address people’s concerns? In: Häyry M, Chadwick R, Árnason V, Árnason G (eds) The ethics and governance of human genetic databases, Cambridge University Press, Cambridge, pp 249–256, at 252

  16. Hendriks CM, Grin J (2007) Enacting reflexive governance: the politics of Dutch transitions to sustainability. J Environ Policy Plan 9(4):333–350

  17. Holm S (2009) Me, myself, I—against narcissism in the governance of genetic information. In: Widdows H, Mullen C (eds) The governance of genetic information: who decides?. Cambridge University Press, Cambridge, pp 37–50

  18. House of Lords Science and Technology Committee (2009) Genomic Medicine. Second Report of Session 2008–2009, para 6.15

  19. Hunter KG, Laurie G (2009) Involving publics in biobank governance: moving beyond existing approaches. In: Widdows H, Mullen C (eds) The governance of genetic information: who decides?. Cambridge University Press, Cambridge, pp 151–177

  20. Jones D, MacKellar C (2009) Consent for biobank tissue in somatic-cell nuclear transfer. Lancet 374(9693):861–863

  21. Karinen R, Guston DH (2010) Towards anticipatory governance: the experience of nanotechnology. Sociol Sci Yearb 27(4):217–232. doi:10.1007/978-90-481-2835-1_12

  22. Kaye J (2006) Do we need a uniform regulatory system for biobanks across Europe? Euro J Hum Genet 14:245–248. doi:10.1038/sj.ejhg.5201530

  23. Knoppers BM (2009a) Genomics and policymaking: from static models to complex systems? Hum Genet 125:375–379

  24. Knoppers BM (2009b) Challenges to ethics review in health research. Health Law Rev 17(2–3):47–52

  25. Laurie G (2009) The role of the UK Biobank Ethics and Governance Council. Lancet 374(9702):1676

  26. Laurie G, Bruce A, Lyall C (2009) The role of values and interests in the governance of the life sciences: learning lessons from the “Ethics+” approach of UK Biobank. In: Lyall C, Papaioannou T, Smith J (eds) The limits to governance: the challenges of policy-making for the new life sciences. Ashgate, Farnham, pp 51–77

  27. Laurie G et al (2010) Managing access to biobanks: how can we reconcile individual privacy and public interests in genetic research? Med Law Int 10(4):315–337

  28. Lenoble J, Maesschalck M (2010) Renewing the theory of public interest: the quest for a reflexive and learning-based approach to governance. In: de Schutter O, Lenoble J (eds) Reflexive governance: redefining the public interest in a pluralistic world. Hart Publishing, Oxford, pp 3–21

  29. Lowrance WW, Collins FS (2007) Identifiability in genomic research. Science 317:600–602

  30. Meslin EM (2010) The value of using top–down and bottom–up approaches for building trust and transparency in biobanking. Public Health Genomics 13(4):207–214

  31. Mitchell R et al (2011) Genomics, biobanks, and the trade-secret model. Science 332(6027):309–310

  32. O’Doherty KC, Hawkins A (2010) Structuring public engagement for effective input in policy development on human tissue biobanking. Public Health Genomics 13:197–206

  33. Otlowski M (2009) Developing an appropriate consent model for biobanks: in defence of ‘broad’ consent. In: Kaye J, Stranger M (eds) Principles and practice in biobank governance. Ashgate, Farnham, pp 79–92

  34. Public Population Project in Genomics (P3G) (2011) www.p3g.org. Last visited 25 April 2011

  35. Ruyter KW et al (2010) From research exemption to research norm: recognizing an alternative to consent for large scale biobank research. Med Law Int 10(4):287–313

  36. Schön D (1994) The reflective practitioner: how professionals think in action. Ashgate, Farnham

  37. Schröder C, Heidtke KR, Zacherl N, Zatloukal K, Taupitz J (2010) Safeguarding donors’ personal rights and biobank autonomy in biobank networks: the CRIP privacy regime. Cell Tissue Bank. doi:10.1007/s10561-010-9190-8

  38. Shickle D, Griffin M, El-Arifi K (2010) Inter- and intra-biobank networks: classification of biobanks. Pathobiology 77(4):181–190

  39. Stranger M, Bell E, Nicol D, Otlowski M, Chalmers D (2008) Human genetic databases in Australia: indications of inconsistency and confusion. New Genet Soc 27(4):311–321

  40. Sutrop M (2007) Trust. In: Häyry M, Chadwick R, Árnason V, Árnason G (eds) The ethics and governance of human genetic databases. Cambridge University Press, Cambridge, pp 190–198

  41. Taylor MJ, Townend D (2010) Issues in protecting privacy in medical research using genetic information and biobanking: the PRIVILEGED project. Med Law Int 10(4):253–268

  42. Vincent-Jones P, Mullen C (2010) From collaborative to genetic governance: the example of healthcare services in England. In: de Schutter O, Lenoble J (eds) Reflexive governance: redefining the public interest in a pluralistic world. Hart Publishing, Oxford, pp 147–178

  43. Wallace S, Bédard K, Kent A, Knoppers BM (2008) Governance mechanisms and population biobanks: building a framework for trust. GenEdit 6:1–11. http://www.humgen.umontreal.ca/int/GE/en/2008-2.pdf

  44. Williams R (2006) Compressed foresight and narrative bias: pitfalls in assessing high technology futures. Sci Cult 15(4):327–348

  45. Winickoff D (2007) Partnership in UK Biobank: a third way for genomic property? Journal of Law. Med Ethics 35(3):440–456

  46. Winickoff D (2009) From benefit sharing to power sharing: partnership governance in population genomics research. In: Kaye J, Stranger M (eds) Principles and practice in biobank governance. Ashgate, Franham, pp 53–66

  47. Wynne B (1992) Uncertainty and environmental learning: reconceiving science and policy in the preventive paradigm. Glob Environ Change 2(2):111–127

  48. Yarborough M, Fryer-Edwards K, Geller G, Sharp RR (2009) Transforming the culture of biomedical research from compliance to trustworthiness: insights from nonmedical sectors. Acad Med 84(4):472–477

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Correspondence to Graeme Laurie.

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Laurie, G. Reflexive governance in biobanking: on the value of policy led approaches and the need to recognise the limits of law. Hum Genet 130, 347 (2011). https://doi.org/10.1007/s00439-011-1066-x

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Keywords

  • Public Interest
  • Governance Mechanism
  • Legal Provision
  • Governance Framework
  • Governance Regime