Semantic, pedantic or paradigm shift? Recruitment, retention and property in modern population biobanking

European Journal of Health Law

Volumn 16, Issue 1, 2009, Pages 27-43

  Harmon, Shawn H E ^a  

^a UNIVERSITY OF EDINBURGH   (United Kingdom)

Author keywords

Consent; Human tissue; Interests; Population biobank; Property; Withdrawal

Indexed keywords

ARTICLE; HEALTH CARE FACILITY; HUMAN; HUMAN DIGNITY; HUMAN RIGHTS; INFORMED CONSENT; MEDICOLEGAL ASPECT; POPULATION BIOBANKING; SEMANTICS; LEGAL ASPECT; TISSUE PRESERVATION;

BIOLOGICAL SPECIMEN BANKS; HUMANS; INFORMED CONSENT; TISSUE PRESERVATION;

EID: 66149129965     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/157180909X400213     Document Type: Article

References (55)

1. J. Kaiser"Population Databases Boom: From Iceland to the US" (2002) 298 Science 1158-1161. (Pubitemid 35285457)
2. See G. Helgesson et al. "Ethical Framework for Previously Collected Biobank Samples" (2007) 25 Nature Biotechnology 973-976, and others, including note 3, infra. (Pubitemid 47517629)
3. "First International Conference of Tiss: EU Project: Ethical and Legal Aspects of Research with Human Tissue in Europe", 26-28 June 2008, Göttingen.
4. For more on the Tiss:EU Project, see http://www.tisseu.uni-hannover.de/ index.php.
5. I concede that some of the argument may be seen to rest on semantics (ie: the characterisation and naming of what is transpiring at the recruitment/retention phase) but it is ultimately important for our broad understanding of the term "consent" and its retention of power, and for the theoretical basis on which we construct our involvement in biobanks more generally.
6. K. Mason and G. Laurie Mason and McCall Smith's Law and Medical Ethics, 7 th ed (Oxford: OUP, 2006) at 349.
7. See YFv. Turkey (2004) 39 EHRR 34 (ECHR).
8. J. Mill"On Liberty" in M. Warnock (ed.) Utilitarianism, On Liberty and Other Essays (London: Fontana, 1962), at 135. Competence exists when the individual has the ability to: (1) understand and recall information relevant to the medical course under consideration; (2) process or deliberate on that information; (3) decide to accept or reject a particular course, having weighed the nature, risks and consequences of a course as well as the alternatives; and (4) communicate that decision. Special rules and procedures exist with respect to minors and the mentally incapacitated.
9. K. Mason and G. Laurie supra, note 6, at 395-399.
10. One might note here O. O'Neill"Some Limits of Informed Consent" (2003) 29 JME 4-7, who is sceptical about how much we demand of consent, questions the extent to which it truly empowers people, and suggests that its value is really limited to ensuring that people are not deceived.
11. K. Mason and G. Laurie supra, note 6, at 655.
12. For more on the demands of consent in the research setting, see the Medical Research Council's Good Research Practice (2000) and Human Tissue and Biological Samples for Use in Research - Operational and Ethical Guidelines (2001/2005), the European Unions Directive 2001/20/EC and Directive 2005/28/EC, both of which lay down good practice for clinical trials on medicinal products for human use, the European Councils Convention on Biomedicine (1997), the World Medical Associations Helsinki Declaration (2000), the Council for International Organizations of Medical Sciences' Guidelines on Human Subject Research in Developing Countries (2002), and the Council of Europe's Additional Protocol on Human Subject Research (2005).
13. B. Elger and A. Caplan"Consent and Anonymization in Research Involving Biobanks" (2006) 7 EMBO Reports 661-666.
14. For more on their nature, see G. Williams "Bioethics and Large-Scale Biobanking: Individualistic Ethics and Collective Projects" (2005) 1 GSP 50-66.
15. With respect to practices concerning previously existing biobanks, one might note the Alder Hey and Bristol scandals in the UK. With respect to missteps regarding prospective biobanks, one might note the Icelandic Health Sector Database.
16. Note that Australia, Canada, Estonia, France, Germany, Iceland, Japan, Sweden, Switzerland, the UK and the USA have all issued their own guidelines, and see the WMA's Declaration on Ethical Considerations Regarding Health Databases (2002), UNESCO's International Declaration on Human Genetic Data (2003) the COE's draft Recommendation on Research on Biological Materials of Human Origin (2006), and the OECD's draft Guidelines for Human Biobanks and Genetic Research Databases (2008).
17. B. Knoppers"Biobanking: International Norms" (2005) 33 J Law Med Ethics 7-14. (Pubitemid 40591966)
18. B. Elger and A. Caplan, supra, note 13. However, note might be taken of the efforts of P3G to produce a generic consent form so as reduce inconsistency and inefficiency: B. Knoppers"Biobanking, Population Genetic research and Informed Consent", presented at "One Origin, One Race, One Earth: Genetics Human Rights and the Next Phase of Human Evolution", U. of Calgary, 16 November 2007, Calgary, Canada.
19. The USA has wedded this to an expansion of the definition of "non-identifiable"; information so characterised is seen as carrying no risk to the originator and so relieves the researcher of the burden of re-contacting.
20. A "robust consent", in my view, is an ongoing, information-reliant exchange between parties, and this cannot effectively and efficiently be realised in the biobank setting. Having said that, I concede that some might defend this broad consent as perfectly justifiable (or robust) on the basis that research activities with which the biobank is associated will be made public and people who bother to keep themselves informed often have the right to withdraw their consent, thereby preserving consent as a process.
21. An approach which recognises consent as a process rather than an event, but which has been challenged as prohibitively expensive, inefficient and potentially impossible: P. Furness and M. Nicholson "Obtaining Explicit Consent for the Use of Archival Tissue Samples: Practical Issues" (2004) 30 JME 561-564.
22. A notion which has been strenuously resisted by many stakeholders who are concerned with coinmodification of the (whole) human body and with tissue originators deriving any financial benefit therefrom.
23. O. Corrigan"Empty Ethics: The Problem with Informed Consent" (2003) 25 Sociology of Health and Illness 768-792. (Pubitemid 37533088)
24. K. Mason and G. Laurie supra, note 6, at 682.
25. A proposition which finds its origins with Coke (see P. Skegg"Human Corpses, Medical Specimens and the Law of Property" (1975) Anglo-Am Law Rev 412) and which has been reiterated in judicial precedents and policy statements, including the Nuffeld Council on Bioethics, Human Tissue: Ethical and Legal Issues (London: NufEeld Council, 1995), and the UK Human Tissue Act 2004.
26. And under exceptions that have been characterised as misguided and insufficient: see R. Hardcastle Law and the Human Body: Property Rights, Ownership and Control (Oxford: Hart Publishing, 2007), at 143.
27. See the discussion in S. Harmon"A Penny For Your Thoughts, A Pound For Your Flesh: Implications of Recognizing Property in Human Body Parts" (2006) 7 Med Law Int 329-354. (Pubitemid 44386918)
28. An outcome recognised by Broussard J, dissenting, in Moore v. Regents of the University of California (1990), 793 P 2d 479 (Cal SC), reversing (1988), 249 Cal R494 (CA).
29. P. Matthews"Whose Body? People As Property" (1982) 36 Current Legal Problems 193-239, and K. Gray Elements of Land Law (London: Butterworths, 1987), at 8.
30. P. Matthews, ibid., at 193-195 J. Weisman"Organs As Assets" (1993) 27 Israel LR 610-623, at 610 R. Smith, Property Law, 3rd ed. (London: Longman, 2000), at 3, and others. And see recent judicial statements to this effect in Phillips v. Washington Legal Foundation (1998), 524 US 156 (SC) and Yanner v. Eaton, [1999] HCA 53 (HCA).
31. In the UK, this was enunciated in W. Blackstone, Commentaries on the Laws of England, 1783, 9th ed., vol I, at 129, and recently reiterated in the medical context in Re F' (Mental patient: Sterilisation), [1990] 2 AC 1 (HL) and Chester V. Afshar, [2005] 1 AC 134 (HL).
32. J. Harris "Who Owns My Body?" (1996) 16 Oxford J Law Soc 55-84, at 56-57.
33. P. Matthews, supra, note 29, at 252-255, and K. Gray Elements of Land Law (London: Butterworths, 1987), at 11, where it is noted that the changing objects of property has resulted in the abandonment of property in wives and slaves.
34. J. Harris, supra, note 32, at 60-61, and S. Worthington Personal Property Law (Oxford: Hart Publishing, 2000).
35. S. Worthington ibid., at 3.
36. I recognise that the extension of the property model to originators would necessitate rationalisation of both the property and human tissue use regimes. Exploring the contours of that rationalisation is beyond the scope of this modest work. I also recognise that the tide is running against the recognition of property at present, though the effect of such a recognition might be that practices around human tissue use might become more principled: see R. Hardcastle supra, note 26, at 172.
37. I recognise that a widely shared concern with the adoption of a property model is that a market may emerge around the sourcing of body materials from originators. Addressing this concern is beyond the scope of this short article, but I note several points: (1) property is not inseparable from markets; (2) individuals can have property rights in something without the concomitant right to divest themselves of that item for money; (3) resistance to a property model has done nothing to avoid the formation of (black) markets in body material.
38. One can assume that a person who loses a finger in an accident would claim a right to possess and control (a property interest in) that excised part despite its separation, and there would be few so bold as to deny that interest, but there is little in the way of legal protection of that interest.
39. Hardcastle, supra, note 26, at 1 and 173, articulates four of these interest. With respect to the first two interests, however, he suggests that they are interests of control - control of the disposal and profits. However, I believe we need to recognise that we do not live as islands onto ourselves (to borrow a phrase from J. Donne, Meditation XVII"Devotions Upon Emergent Occasions" (1624), at http://en.wikipedia.org/wiki/john-donne [accessed 24 Aug. 2005]). As such, we should recognise that full and individual "control" may rarely ever be possible (or appropriate) ; there are many things, both important and intimate, that we do not "control". Though "control" may be the deep-seated desire, I think the defensible interest is rather one of "influence".
40. This interest is grounded on solidarity, a moral value we all share to varying degrees and one that underscores our shared objectives (and indeed duties) toward contributing to the welfare of our shared communities and our fellow man. This value has been explored in greater detail by S. Harmon"Solidarity: A. (New) Ethic for Global Health Policy" (2006) 14 Health Care Analysis 215-236.
41. See UK Biobank, Ethics and Governance Framework, v. 3, 2007, at http://www.ukbiobank.ac.uk/docs/EGF20082.pdf [accessed 17 July 2008].
42. Rec (2006) 4, March 15, 2006, 958th Meeting of the Ministers' Deputies.
43. S. Harmon"The Recommendation on Research on Biological Materials of Human Origin: Another Brick in the Wall" (2006) 13 (3) European J Health Law 293-310. For a further examination of the final version of the Recommendation, see H. Nys"Research on Human Biological Materials and the Council of Europe: Some Unanswered Questions, Overlaps and Empty Boxes" (2008) 15 European] Health Law 1-6.
44. A duty suggested by G. Williams and D. Schroeder"Human Genetic Banking: Altruism, Benefit and Consent" (2004) 23 New. Gen and Soc. 89-103, at 97. (Pubitemid 38621785)
45. It is important to erect duties for private, profit-seeking research entities because biobank usage is now, and is expected in future, to be driven largely by economic interests, and because publics have concerns around the role and conduct of profit-seeking entities in human subject research and public healthcare agenda-setting: G. Williams supra, note 14 S. Wilkinson" Biomedical Research and the Commercial Exploitation of Human Tissue" (2005) 1 GSP 27-40, and others.
46. I recognise that one cannot convey more interests or rights in an item than s/he, by law, holds, but of course the custodian, upon coming into possession of items of a certain character (i.e.: excised tissue and associated transfer agreement) may have a wider range of interests and exercisable rights than that held by the conveying originator.
47. It is well known that trust is an essential component of the success of biobanks and of medical research more generally: see M. Hannson"Building on Relationships of Trust in Biobank Research" (2005) 31 JME 415-418, and G. Haddow G. Laurie S. Cunningham-Burley and K. Hunter"Tackling Community Concerns About Commercialisation of Genetic Research: A Modest Interdisciplinary Proposal" (2007) 64 Social Science and Med 272-282.
48. Although this may be as straight forward as consulting the biobanks website.
49. It is difficult to imagine how the recognition of personality rights in continental systems would be infringed by the use of excised tissue and anonymised data in closed laboratory settings.
50. I concede that something short of an actual distress-provoking event may occur. For example, one's confidence in the system of protection may diminish, or one's view of privacy may simply change but one imagines that, in the normal course, this will be a rarity.
51. I have tried to address the "what's in it for me" question, and it is the tragedy of our times or our nature that I am forced to do so. I concede that I may not have addressed it satisfactorily for those who feel I have taken something away (from the individual), but I suggest that, in exchange for that withdrawal, I have offered a strengthening of the overall system together with an assurance of (potentially) greater stability of the resource. Moreover, this is no less final than sample recruitment in the human stem cell setting where private or public/private entities secure material from which to derive stem cell lines.
52. I take notice of the practices of UK Biobank, which has gone to great lengths to promote trust and transparency. For more on UK Biobank, see http://www.ukbiobank.ac.uk/.
53. This is particularly so in instances where originators are not provided with information derived from their tissue that may be relevant to them, as is the norm.
54. See the terminological expansion articulated above and explained in footnote 19 supra.
55. B. Elger and A. Caplan supra,., note 13, and B. Knoppers, supra, note 17.