The recommendation on research on biological materials of human origin: Another brick in the wall

European Journal of Health Law

Volumn 13, Issue 3, 2006, Pages 293-310

  Harmon, Shawn H E ^a,b  

^a ESRC Centre for Economic and Social Research on Innovation in Genomics   (United Kingdom)

^b UNIVERSITY OF EDINBURGH   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BIOASSAY; BIOMEDICAL TECHNOLOGY ASSESSMENT; EUROPE; GOVERNMENT; HUMAN; HUMAN TISSUE; LAW; MEDICAL RESEARCH; REVIEW; TISSUE ENGINEERING; ARTICLE; COMMODIFICATION; DONOR; HEALTH CARE FACILITY; HUMAN EXPERIMENT; HUMAN RIGHTS; INFORMED CONSENT; LEGAL ASPECT; PRACTICE GUIDELINE; RESEARCH; TRANSPLANTATION;

BIOLOGICAL SPECIMEN BANKS; COMMODIFICATION; EUROPE; HUMAN EXPERIMENTATION; HUMAN RIGHTS; HUMANS; INFORMED CONSENT; PRACTICE GUIDELINES; RESEARCH; TISSUE AND ORGAN PROCUREMENT; TISSUE DONORS;

EID: 33751578119     PISSN: 09290273     EISSN: None     Source Type: Journal    
DOI: 10.1163/157180906778852420     Document Type: Review

References (44)

1. The human tissue market was calculated at over US$4 billion in 2001: M. Reymond et al., "Ethical, Legal and Economic Issues Raised by the Use of Human Tissue in Postgenomic Research" (2002) 20 Dig. Dis. 257-265.
2. Convention for the Protection of Human Rights and Dignity of Human Beings with regard to the Applications of Biology and Medicine, ETS No. 164, 1997.
3. See Articles 11, 12, 16, 17, 21 and 22 of the Biomedicine Convention, and its associated Explanatory Report, all discussed in S. Gevers, "Human Tissue Research With Particular Reference to DNA Banking" in J. Gevers et al. (eds), Health Law, Human Rights and the Biomedicine Convention (Leiden: Martinus Nijhoff, 2005) 231-243.
4. Additional Protocol to the Biomedicine Convention, ETS No. 195, 2005.
5. Rec(2006)4, March 15, 2006, 958th meeting of the Ministers' Deputies.
6. Steering Committee on Bioethics, Explanatory Memorandum, CDBI (2005) 5REV2, at 1-2.
7. Indeed, as conceded in the Preamble and the Explanatory Memorandum, much of the content is already enunciated in other international instruments. In particular, see the European Convention on Human Rights (1950), the European Convention on Personal Data (1981), and the Biomedicine Convention (1997) and its Additional Protocol Concerning Biomedical Research (2005), the UNESCO International Declaration on Human Genetic Data (2003), as well as the more binding EU Personal Data Directive 95/46/EC, and the EU Good Clinical Practice Directive 05/28/EC. The proliferation of regulation, particularly that addressing use of genetic data, which is assumed to be special, is also noted by J. Bovenberg, Property Rights in Blood, Genes and Data: Naturally Yours? (Leiden: Martinus Nijhoff, 2006), at 8-28.
8. Steering Committee on Bioethics, supra, note 6, at 2-3.
9. This represents a continuation of the principles advanced in the Biomedicine Convention (1997), which are discussed in J. Dute, "The Leading Principles of the Convention on Human Rights and Biomedicine" in J. Gevers et al. (eds), supra, note 3, 3-12.
10. Article 2, Clause 3.
11. Article 2, Clause 4, and Article 3.
12. M. Reymond et al., supra, note 1, at 259.
13. For a comment on the confusion of terminology used in this particular research area, see B. Elger & A. Caplan, "Consent and Anonymization in Research Involving Biobanks" (2006) 7 EMBO Reports 661-666.
14. Article 10.
15. Article 12.
16. Articles 21 and 23.
17. Article 22, Clause 1.i.
18. Article 22, Clause 1.ii.
19. Article 15, Clauses 1, 2 and 3, and Article 22, Clause 2.
20. Article 15, Clause 1.
21. Article 3, Clause ii.
22. For more on their nature, see G. Williams, "Bioethics and Large-Scale Biobanking: individualistic Ethics and Collective Projects" (2005) 1 G.S.P. 50-66.
23. For more on solidarity, see S. Harmon, "Regulation of Human Genomics and Genetic Biotechnology: Risk, Values and Analytical Criteria" (2005) INNOGEN Working Paper 40, at www.innogen.ac.uk/assets_innogen/dynamic/ 1132844739842/Innogen-Working-Paper-40.pdf,
24. S. Harmon, "From Engagement to Re-Engagement: The Expression of Moral Values in European Patent Proceedings, Present and Future" (2006) 31 E.L.Rev. 642-666,
25. and S. Harmon, "Solidarity: A (New) Ethic for Global Health Policy" (2006), forthcoming in Health Care Analysis.
26. I recognise that a right of withdrawal is usually extended as a means of promoting trust (see UK Biobank and Generation Scotland), but one can argue that the right really has very little bearing on promoting trust as it will only ever be exercised when there is a loss of trust for whatever reason. In any event, there are more effective ways to promote/ensure trust: see infra.
27. Preamble.
28. Article 7.
29. See G. Williams, supra, note 22, and others.
30. See S. Wilkinson, "Biomedical Research and the Commercial Exploitation of Human Tissue" (2005) 1 G.S.P. 27-40.
31. See G. Haddow, G. Laurie, S. Cunningham-Burley & K. Hunter, "Tackling Community Concerns About Commercialisation of Genetic Research: A Modest Interdisciplinary Proposal", forthcoming in Social Science and Medicine.
32. Preamble.
33. Article 14, Clause 2.
34. Article 14, Clauses 2 and 4.
35. Article 14, Clause 5.
36. Articles 18 and 19, Clause 1.
37. Article 19, Clause 2.
38. Article 19, Clause 4.
39. Article 16.
40. And one contained in the Preamble to the Recommendation.
41. G. Williams & D. Schroeder, "Human Genetic Banking: Altruism, Benefit and Consent" (2004) 23 New. Gen & Soc. 89-103, at 97.
42. For more on the need of a broader (global) view and a solidarity-based approach in human subject research, see S Harmon, "Solidarity: A (New) Ethic for Global Health Policy" (2006), forthcoming in Health Care Analysis.
43. Note the Icelandic and the Estonian examples.
44. Article 19, Clause 3.