A solidarity-based approach to the governance of research biobanks

Medical Law Review

Volumn 21, Issue 1, 2013, Pages 71-91

  Prainsack, Barbara ^a   Buyx, Alena ^b  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

Health governance; Research biobanks; Risk.; Solidarity

Indexed keywords

ARTICLE; COMPENSATION; ETHICS; EUROPE; FEEDBACK SYSTEM; HEALTH CARE FACILITY; HUMAN; INFORMED CONSENT; LEGAL ASPECT; MEDICAL RESEARCH; PERSONAL AUTONOMY;

BIOLOGICAL SPECIMEN BANKS; BIOMEDICAL RESEARCH; COMPENSATION AND REDRESS; EUROPE; FEEDBACK; HUMANS; INFORMED CONSENT; PERSONAL AUTONOMY;

EID: 84882953314     PISSN: 09670742     EISSN: 14643790     Source Type: Journal    
DOI: 10.1093/medlaw/fws040     Document Type: Article

References (91)

1. G Majone, 'From the Positive to the Regulatory State - Causes and Consequences from Changes in the Modes of Governance' (1997) 17 J Public Policy 139-67
2. RAW Rhodes, Understanding Governance (Open University Press, Buckingham, 1997)
3. RAW Rhodes, 'Understanding Governance: Ten Years On' (2007) 28 Organization Stud 1243-64
4. R Baldwin, M Cave, and M Lodge, Understanding Regulation: Theory, Strategy, and Practice (Oxford University Press, Oxford 2011)
5. M Moran, 'The Rise of the Regulatory State in Britain' (2001) 54 Parl Aff19
6. JS Wright, 'The Regulatory State and the UK Labour Government's Re-regulation of Provision in the English National Health Service' (2009) 3 Regul Gov 334-59
7. U Beck, Risk Society: Towards a New Modernity (Sage, London 1992)
8. AE Clarke and others, 'Biomedicalization: Technoscientific Transformations of Health, Illness, and US Biomedicine' (2003) 68 Am Sociol Rev 161-94
9. RV Ericson and A Doyle. (eds), Risk and Morality (University of Toronto Press, Toronto 2003)
10. N Rose, Powers of Freedom. Reframing Political Thought (Cambridge University Press, Cambridge 1999)
11. N Rose, The Politics of Life Itself: Biomedicine, Power and Subjectivity in the Twenty-First Century (Princeton University Press, Princeton, NJ 2006)
12. H Gottweis, Governing Molecules: The Discursive Politics of Genetic Engineering in Europe and the United States (MIT Press, Cambridge, MA 1998)
13. See also NBM Power The Audit Society (Oxford University Press, Oxford 1997)
14. C Hood, H Rothstein, and R Baldwin, The Government of Risk: Understanding Risk Regulation Regimes (Oxford University Press, Oxford 2001)
15. R Tutton, 'Person, Property, and Gift' in O Corrigan and R Tutton (eds), Genetic Databases: Socio-Ethical Issues in the Collection and Use of DNA (Routledge, New York 2004) 19-39
16. H Gottweis and AR Petersen, Biobanks: Governance in Comparative Perspective (Routledge, London 2008)
17. J Kaye and others, Ethical, Legal, and Social Issues Arising from the Use of GWAS in Medical Research (Wellcome Trust, London 2009)
18. European Commission, Expert Group on Dealing with Ethical and Regulatory Challenges of International Biobank Research, Biobanks for Europe: A Challenge for Governance (Brussels 2012)
19. B Prainsack and A Buyx, Solidarity: Reflections on an Emerging Concept in Bioethics (Nuffield Council on Bioethics, London 2011)
20. B Prainsack and A Buyx, 'Solidarity in Contemporary Bioethics' (2012) 26 Bioethics 343-50
21. A Buyx and B Prainsack, 'Lifestyle-related Diseases and Individual Responsibility through the Prism of Solidarity' (2012) 7 Clinical Ethics 79-85
22. B Prainsack and A Buyx, 'Understanding Solidarity (With a Little Help from your Friends): A Response to Dawson and Verweij' (2012)
23. Public Health Ethics 206-210
24. The report's findings rest on an extensive literature analysis (chapter 3). We referenced both books and articles on the topic from the last two decades, such as, eg, J Dean, Solidarity of Strangers: Feminism after Identity Politics (University of California Press, Berkeley 1996)
25. RT Meulen, W Arts and R Muffels (eds), Solidarity in Health and Social Care in Europe (Kluwer, Dordrecht 2010)
26. S Sternø, Solidarity in Europe: The History of an Idea (Cambridge University Press, Cambridge 2004)
27. S Scholz. Political Solidarity (University of Pennsylvania Press, University Park, PA 2008)
28. K Hinrichs 'The Impact of German Health Insurance Reforms on Redistribution and the Culture of Solidarity' (1995) 20 J Health Polit Policy Law 653-87
29. S Boshammer and M Kayß, 'Review Essay: The Philosopher's Guide to the Galaxy of Welfare Theory: Recent English and German literature on Solidarity and the Welfare State' (1998) 1 Ethical Theory Moral Pract 375-85
30. M. Trappenburg. 'Lifestyle Solidarity in the Healthcare System' (2000) 8 Health Care Anal 65-75
31. RE Ashcroft, AV Campbell and S Jones, 'Solidarity, Society and the Welfare State in the United Kingdom' (2000) 8 Health Care Anal 377-94
32. R Chadwick and K Berg, 'Solidarity and Equity: New Ethical Frameworks for Genetic Databases' (2001) 2 Nat Rev Genet 318-21
33. M Häyry, 'Precaution and Solidarity', (2005) 14 Cambridge Q Healthcare Ethics 199-206
34. Prainsack and Buyx, above, n 7
35. It should be noted that our notion of assisting others does not imply that those assisting others are therefore acting in the public interest. One of us regards the question of what and who is acting in the public interest as one that needs to be answered specifically for every case; therefore, we refrain from using the notion of public (or collective) interest altogether.
36. We use the term 'data' to signify the (digital or analogue) representation of the biological matter (eg, the succession of nucleotides in a DNA sequence), whereas 'information' pertains to data that have become meaningful in a particular respect (an annotated DNA sequence, or the interpretation of a DNA sequence in a functional context). See BC Parry, Trading the Genome: Investigating the Commodification of Bio-information (University of Columbia Press, New York 2004)
37. G Pálsson and B Prainsack, 'Genomic Stuff: Governing the (Im)matter of Life' (2011) 5 Int J Commons 259-83
38. D Pullman and others, 'Personal Privacy, Public Benefits, and Biobanks: A Conjoint Analysis of Policy Priorities and Public Perceptions' (2012) 14 Genet Med 229-35
39. L Johnsson and others, 'Hypothetical and Factual Willingness to Participate in Biobank Research' (2010) 18 Eur J Hum Genet 1261-4
40. R Tutton, 'Constructing Participation in Genetic Databases: Citizenship, Governance, and Ambivalence' (2007) 32 Sci Technol Hum Values 172-95
41. See also M Levitt and S Weldon, 'A Well Placed Trust? Public Perceptions of the Governance of DNA Databases' (2005) 15 Crit Public Health 311-21
42. G Williams and D Schroeder, 'Human Genetic Banking: Altruism, Benefit and Consent' (2004) 23 New Genet Soc 89-103
43. M Sutrop, 'Viewpoint: How to Avoid a Dichotomy Between Autonomy and Beneficience: From Liberalism to Communitarianism and Beyond' 269 (2011) J Int Med 376
44. See also, eg, JK Mason and GT Laurie, Law and Medical Ethics (8th edn Oxford University Press, Oxford, 2011, Ch 4)
45. BMA Medical Ethics Today, The BMA Handbook of Medical Ethics and Law (Wiley & Blackwell, London 2012)
46. SHE Harmon, 'Semantic, Pedantic or Paradigm Shift? Recruitment, Retention and Property in Modern Population Biobanking' (2009) 16 Eur J Health Law 27-43
47. Eg AL McGuire and LM Beskow, 'Informed Consent in Genomics and Genetics Research' (2010) 11 Annu Rev Genomics Hum Genet 361-81
48. O O'Neill, 'Some Limits on Informed Consent' (2003) 29 J Med Ethics 4-7
49. J. Wilson, 'Is Respect for Autonomy Defensible?' (2007) 33 J Med Ethics 353-6.
50. The infringement of data protection standards and physical harm would be examples for a particular nature of risk. In the context of biobank-based research, the degree of the former is medium to low, depending on the concrete context; the risk for the latter is extremely low to absent (physical harm is never a direct result of somebody's participation in a research biobank); See also European Commission, above, n 6.
51. Note, however, the conflict between the Havasupai Indians and Arizona State University
52. see A Harmon 'Havasupai Case Highlights Risks in DNA Research' (2010) The New York Times, available at, http://www.nytimes.com/2010/04/22/us/22dnaside.html. accessed 20 September 2012.
53. DNA sequencing-that is, the mapping of all (protein-producing) elements of DNA rather than focusing only on certain areas that are 'flagged up', which is commonly the case, could change the limited predictive value of most genetic markers. A more comprehensive approach to DNA mapping such as DNA sequencing could show the presence of rare variants in a given individual, and the effects of these could be much larger than those of common variants. For the predictive value and actionability of incidental findings in genomic research, see the contributions to issue (2012) 14(4) Genetics Med. See also CE Nabholz and J von Overbeck, 'Gene-Environment Interactions and the Complexity of Human Genetic Diseases' (2004) 36 J Insurance Med 47-45
54. B Prainsack, 'What Are the Stakes? Genetic Nondiscrimination Legislation and Personal Genomics', Guest Editorial (2008)
55. Pers Med 415-8
56. See G Laurie, Genetic Privacy: A Challenge to Medico-legal Norms (Cambridge University Press, Cambridge 2002)
57. See, eg, D Gurwitz, 'Biomarkers: Better Donor Protection' (2011) 470/7333 Nature 175
58. P Taylor, 'Personal Genomes: When Consent Gets in the Way' (2008) 456 Nature 32-3. M Taylor, Genetic Data and the Law: A Critical Perspective on Privacy Protection (Cambridge University Press, Cambridge 2012).
59. J Kaye and others, 'From Patients to Partners: Participant-centric Initiatives in Biomedical Research' (2012) 13 Nat Rev Genet 371-6
60. J Lunshof and others, 'From Genetic Privacy to Open Consent' (2008) 9 Nat Rev Genet 406-11
61. In this paper, Lunshof and others discuss the open consent framework used by the Personal Genome Project in Harvard (http://www.personalgenomes.org/.).
62. The authors' point of departure is that contemporary large-scale genetics and genomics research studies can no longer reliably promise privacy and confidentiality to their participants and thus need to rethink what they ask participants to consent to
63. B Hoffmann, 'Broadening Consent - and Diluting Ethics?' (2009) 35 J Med Ethics 125-9
64. See also Harmon, above, n 14
65. See Laurie, above, n 19
66. Eg, Harmon, above, n 14
67. MG Hansson and others, 'Should Donors be Allowed to Give Broad Consent to Give Consent to Future Biobank Research?' (2006) 7 Lancet Oncol 266-9
68. T Caulfield and J Kaye, 'Broad Consent in Biobanking: Reflections on Seemingly Insurmountable Dilemmas' 10 (2009) Med L Int 85-100
69. A Bhan, 'Use of Blanket Consent for Retrospective Research in Academic Institutions: Need for Scrutiny and Integrating Safeguards' (2010) 7 Indian J Med Ethics 51-3
70. There is a certain analogy here to the way sovereign states gave up a portion of their national sovereignty when they become members of the European Union (EU). The EU can, in certain specific areas, take decisions that can be binding for certain member states even if they have not supported the decision.
71. See, for example, G Tyldum, 'Ethics or Access? Balancing Informed Consent Against the Application of Institutional, Economic or Emotional Pressures in Recruiting Respondents for Research' (2012) 15 Int J Social Res Methodol 199-210
72. Lunshof, above, n 23
73. For an overview, see K Hoeyer, 'The Ethics of Research Biobanking: A Critical Review of the Literature' (2008) 25 Biotechnol Genetic Eng Rev 429-52
74. CM Gere and BC Parry 'The Flesh MadeWord: Banking the Body in the Age of Information' (2006) 1 BioSocieties 83-98
75. BC Parry, Trading the Genome: Investigating the commodification of Bio-information (University of Columbia Press, New York 2004)
76. See Laurie, above, n 19, and Harmon, above, n 14
77. Again see G Laurie, 'Reflexive Governance in Biobanking: on the Value of Policy Led Approaches and the Need to Recognise the Limits of Law' (2011) Hum Genetics 130, 3, 347-356
78. Academy of Medical Sciences, 'A New Pathway for the Regulation and Governance of Health Research' (2011) available at, http://www.acmedsci.ac.uk/p47prid88.html. accessed June 2012.
79. K Saha and JB Hurlbut, 'Research Ethics: Treat Donors as Partners in Biobanks Research' (2011) 478 Nature 312-13
80. For details of how such a system could look, see SM Wolf and others, 'Managing Incidental Findings and research Results in Genomic Research Involving Biobanks and Archived Data Sets' (2012) 14 Genet Med 361-84
81. The ongoing debate about Electronic Health Records is particularly relevant in this context. For an overview, see IS Kohane, 'Using Electronic Health Records to Drive Discovery in Disease Genomics' (2011) 12 Nat Rev Genet 417-28.
82. 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 EMBO Rep 661-6
83. See also I van Hoeyveghen, Risk in the Making. Travels in Life Insurance and Genetics (Amsterdam University Press, Amsterdam 2007).
84. We are grateful to Klaus Hoeyer for this suggestion
85. see D Dobbs, Ie, granting of access to datasets to other researchers; Free Science One Paper at a Time (11 May 2011). Wired. Available at, http://m.wired.com/wiredscience/2011/05/free-science-one-paper-at-a-time-2/all/1. accessed 3 May 2012.
86. See also S Leonelli and R Bastow, 'Sustaining Digital Infrastructures' (2010)
87. EMBO Rep 730-4
88. H Widdows and C Mullen, The Governance of Genetic Information (Cambridge University Press, Cambridge 2010). The proposed model for the governance of solidarity-based research biobanks resonates with evidence from empirical research. For example, CM Simon and others, 'Active Choice but Not Too Active: Public Perspectives on Biobank Consent Models' (2011)
89. Genet Med 821-31, recently found in a survey and focus-group-based study involving close to 800 respondents from biobank-based research studies in the USA that '[m]any individuals want to make an active and informed choice at the point of being approached for biobank participation but are prepared to consent broadly to future research use and to forego additional choices as a result'
90. See also G Haddowand. others, 'Tackling Community Concerns about Commercialisation and Genetic Research: A Aodest Interdisciplinary Proposal' (2007) 64 Social Sci Med 272-82.
91. See Laurie, above, n 24