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In the Ruins of Babel: Pitfalls on the Way toward a Universal Language for Research Ethics and Benefit Sharing
Published online by Cambridge University Press: 20 May 2011
Extract
At the end of a paper on international research ethics published in the July-August 2010 issue of the Hastings Center Report, London and Zollman argue the need for grounding our duties in international medical and health-related research within a broader normative framework of social, distributive, and rectificatory justice. The same goes for Thomas Pogge, who, in a whole range of publications during the past years, has argued for a human-rights-based approach to international research. In a thought-provoking paper in the June 2010 issue of the American Journal of Bioethics, Angela J. Ballantyne argues that “the global bioethics priority” in medical and health-related research ethics today is how to do research fairly in an unjust world.
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References
1. London, AJ, Zollman, KJS.Research at the auction block. Problems for the fair benefit approach to international research. Hastings Center Report 2010;40:34–45.CrossRefGoogle Scholar
2. In the rest of this paper, for the sake of brevity and convenience I use ”international research” instead of ”international medical and health-related research.”
3. Ballantyne, A.How to do research fairly in an unjust world. American Journal of Bioethics 2010;10:26–35.CrossRefGoogle Scholar
4. An earlier attempt at using this narrative to adress contemporary issues in bioethics is found in Karlsen, JR, Solbakk, JH, Strand, R. In the ruins of Babel: Should biobank regulations be harmonized? In: Solbakk, JH, Holm, S, Hofmann, B, eds. The Ethics of Research Biobanking. Dordrecht, the Netherlands: Springer; 2009:331–43.CrossRefGoogle Scholar
5. Ad Hoc Committee on Health Research Relating to Future Intervention Options. Investing in Health Research and Development. Geneva: World Health Organization; 1996.
6. Matsoso, P, Auton, M, Banoo, S, Fomundam, H, Leng, H, Noazin, S. How Does the Regulatory Framework Affect Incentives for Research and Development? Study Commissioned for the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH): World Health Organization; 2005; available at http://www.who.int/intellectualproperty/studies/Study5.pdf (last accessed 5 Aug 2010)Google Scholar; Petryna, A.Clinical trials offshored: On private sector science and public health. BioSocieties 2007;2:21–40CrossRefGoogle Scholar; Thiers, FA, Sinskey, AJ, Berndt, ER.Trends in the globalization of clinical trials. Nature Reviews Drug Discovery 2008;7:13–4.CrossRefGoogle ScholarGlickman, SW, McHutchison, JG, Peterson, ED, Cairns, CB, Harrington, RA, Califf, RM, Schulman, KA. Ethical and scientific implications of the globalization of clinical research. New England Journal of Medicine 2009;360:816–23.CrossRefGoogle ScholarPubMed
7. Chirac, P, Torreele, E. Global framework on essential health R&D. Lancet 2006;367:1560–1CrossRefGoogle Scholar; Garrafa, V, Solbakk, JH, Vidal, SM, Lorenzo, C.Between the needy and the greedy: The quest for a just and fair ethics of clinical research. Journal of Medical Ethics 2010;36:500–4CrossRefGoogle ScholarPubMed; Solbakk, JH, Vidal, SM. Research ethics, clinical. In: Chadwick, R, ed., Encyclopedia of Applied Ethics (forthcoming).Google Scholar
8. Pogge, T.Intellectual property rights and access to essential medicines. Policy Innovations; 2007; available athttp://www.policyinnovations.org/ideas/policy_library/data/FP4 (last accessed 17 Nov 2010).Google Scholar
9. See note 8, Pogge 2007:2.
10. See note 8, Pogge 2007:9.
11. See note 8, Pogge 2007:10
12. See note 8, Pogge 2007:10.
13. See note 8, Pogge 2007:10
14. Habermas, J, The Theory of Communicative Action, translated by McCarthy, Thomas, Cambridge: Polity; 1984–87.Google Scholar
15. For a detailed analysis of this debate, see Solbakk, JH.Use and abuse of empirical knowledge in contemporary bioethics. A critical analysis of empirical arguments employed in the controversy surrounding studies of maternal-fetal HIV-transmission and HIV-prevention in developing countries. Medicine, Health Care, and Philosophy 2004;7:5–16.CrossRefGoogle Scholar
16. Lurie, P, Wolfe, S.Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. New England Journal of Medicine 1997;337:853–6CrossRefGoogle ScholarPubMed; Editorial, Angell M.Investigator’s responsibilities for human subjects in developing countries. New England Journal of Medicine 2000;342:967–9.Google Scholar
17. London, AJ.Justice and the human development approach to international research. Hastings Center Report 2005;35:24–37 at p. 27.CrossRefGoogle ScholarPubMed
18. For an account of these power struggles, see, for example, the open letter dated September 1, 2004, of P. Laurie and S.M. Wolfe, deputy director and director of Public Citizen’s Health group in the United States, to D.A. Lepay, at the Food and Drug Administration’s Office of Science and Health Coordination: “[T]he FDA has been a leading force in attempts to undermine restrictions on placebo use in clinical trials, both domestically and abroad. [reference is here made to paragraph 29 of the 2004 version of the Declaration of Helsinki on the use of placebo] . . . Ironically, Paragraph 29 has already been weakened due, in significant part, to FDA objections (as a result, a confusing ‘clarification’ was added to the DOH), but the agency is apparently not yet satisfied. The Department of Health and Human Services (which includes the FDA) has also objected to the extremely reasonable DOH requirement that effective medications be provided to all study participants at the conclusion of the research (Paragraph 30). . . . FDA’s efforts to undermine this Paragraph may also yield fruit, as the WMA Council has adopted yet another ‘clarification’ that seeks to weaken the stronger language in the actual body of the DOH”; Letter urging FDA not to undermine the Declaration of Helsinki; available at http://www.citizen.org/Page.aspx?pid=3180. For this power struggle, see also Lie, RK, Emanuel, E, Grady, C, Wendler, D.The standard of care debate: The Declaration of Helsinki versus the international consensus opinion. Journal of Medical Ethics 2004;30:190CrossRefGoogle ScholarPubMed; Schuklenk, U.The standard of care debate: Against the myth of an "international consensus opinion." Journal of Medical Ethics 2004;30:194CrossRefGoogle Scholar; Blackmer, J, Haddad, H.The Declaration of Helsinki: An update on paragraph 30. Canadian Medical Association Journal 2005;173:1052CrossRefGoogle ScholarPubMed; Wolinsky, H.The battle of Helsinki. Two troublesome paragraphs in the Declaration of Helsinki are causing a furor over medical research ethics. EMBO Reports 2006;7:670–2CrossRefGoogle Scholar; bronxdoc. FDA abandons Declaration of Helsinki for international clinical trials. Global Bioethics Blog, June 1, 2008; available at http://www.socialmedicine.org/2008/06/01/ethics/fda-abandons-declaration-of-helsinki-for-international-clinical-trials/. The sad irony of this power struggle is that the FDA (in close alliance with the American Medical Association and key figures at the Department of Clinical Bioethics at the NiH) played a crucial role in watering down both the restrictions on the use of placebo in the Declaration of Helsinki and the posttrial access requirements. However, as the watering down did not go as far as the FDA wanted it to go, the FDA decided in 2008 to stop referring to the Declaration in their guidelines, and instead make reference to the Good Clinical Practice (GCP) guidelines developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The stakeholders behind this “ethics initiative” are drug regulators from the most affluent parts of the world such as the European Union, Japan, the United States, and industry representatives from the same countries. Their guidelines can therefore hardly be said to represent a language that will be of help in bridging the medical gaps that today exist between the affluent and impoverished inhabitants of the global village.
19. Declaración de Córdoba sobre Ética en Investigaciones con Seres Humanos. II Congreso de la Red Latino-Americana y del Caribe de Bioética - Redbioética/Unesco. Córdoba, Argentina; 2008; available at http://www.unesco.org.uy/shs/es/areas-de-trabajo/ciencias-sociales/declaraciones.html (last accessed 12 Aug 2010).
20. Kottow, MH.Vulnerability: What kind of principle is it? Medicine, Health Care and Philosophy 2004;7:281–7CrossRefGoogle Scholar; Solbakk, JH. Vulnerability: A futile or utile principle in health care ethics? In: Chadwick, R, ten Have, H, Meslin, E, eds. The Sage Handbook of Health Care Ethics: Core and Emerging Issues. Los Angeles: Sage; 2011:228–38.CrossRefGoogle Scholar
21. See note 8, Pogge 2007:22.
22. See note 8, Pogge 2007:22.
23. See note 8, Pogge 2007:22.
24. See note 8, Pogge 2007:23.
25. See note 8, Pogge 2007:23.
26. Declaration of Helsinki 2008, Article 6: “In medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests”; available at http://www.wma.net/en/30publications/10policies/b3/.
27. See note 7, Solbakk, Vidal forthcoming.
28. Hansson, MG, Dillner, J, Bartram, CR, Carlson, JA, Helgesson, G.Should donors be allowed to give broad consent to future biobank research? The Lancet Oncology 2006;7:266–9CrossRefGoogle ScholarPubMed; Lunshof, JH, Chadwick, R, Vorhaus, DB, Church, DM. From genetic privacy to open consent. Nature Reviews Genetics 2008;9:406–11.CrossRefGoogle ScholarPubMed
29. For a more detailed critique of these conceptions, see Karlsen JR, Solbakk JH. Ethical endgames. Broad consent for narrow interests. Open consent for closed minds; Cambridge Quarterly of Healthcare Ethics, forthcoming.
30. Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries. Ethics: Fair benefits for research in developing countries. Science 2002;298:2133–4; Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries. Moral standards for research in developing countries: From ”reasonable availability” to ”fair benefits.” Hastings Center Report 2004;34:17–27; Emanuel, EJ. Benefits to host countries. In: Emanuel, EJ, Grady, C, Crouch, RA, Lie, RK, Miller, FK, Wendler, D, eds. The Oxford Textbook of Clinical Research Ethics. New York: Oxford University Press; 2008:719–28.Google Scholar
31. See note 16, London 2005:27.
32. See note 3, Ballantyne 2010:28.
33. See note 16, London 2010:41.
34. This notion, on which the fair benefit approach is based, originates from Alan Wertheimer, who makes a distinction between ”harmful exploitation” and ”mutually advantageous explotation”: “By mutually advantageous exploitation, I refer to those cases in which both parties (the alleged exploiter and the alleged exploitee) reasonably expect to gain from the transaction as contrasted with the pretransaction status quo. . . . I shall generally presume that mutually advantageous transactions are also consensual”; Wertheimer A. Exploitation on clinical research. In: Hawkins, S, Emanuel, EJ, eds. Exploitation and developing countries. The ethics of clinical research. Princeton, NJ: Princeton University Press; 2008:63-104 at pp. 67–8Google Scholar. An easier way of stating what is meant by mutually advantageous exploitation is to say that the transaction of benefit taking place between the parties leaves all of them better off.
35. ”The European & Developing Countries Clinical Trials Partnership (EDCTP) was created in 2003 as a European response to the global health crisis caused by the three main poverty-related diseases of HIV/AIDS, malaria and tuberculosis. These diseases account for over 6 million deaths each year, and the numbers are growing. Sub-Saharan Africa is the world’s worst-affected region where besides ravaging lives, they impede development and cause poverty”; EDCTP Homepage, http://www.edctp.org/About-EDCTP.2.0.html (last accessed). EDCTP involves all sub-Saharan African countries plus 14 participating European Union (EU) member states as well as Norway and Switzerland.
36. Figures are from the draft report Mapping African Research Ethics Capacity (MARC), a EDCTP-sponsored initiative from 2010.
37. See note 8, Pogge 2007:34.
38. UNESCO. Article 8, Universal Declaration of Bioethics and Human Rights; 2005; available athttp://portal.unesco.org/shs/en/ev.php-URL_ID=1883&URL_DO=DO_TOPIC&URL_SECTION=201.html (last accessed 6 Aug 2010).Google Scholar
39. For a detailed analysis of this principle, see Solbakk, JH. The principle of respect for human vulnerability and global bioethics. In: Chadwick, R, ten Have, H, Meslin, E, eds. Health Care Ethics in an Era of Globalisation. Sage (forthcoming).Google Scholar
40. UNESCO. Article 15, Universal Declaration of Bioethics and Human Rights; 2005; available athttp://portal.unesco.org/shs/en/ev.php-URL_ID=1883&URL_DO=DO_TOPIC&URL_SECTION=201.html (last accessed 6 Aug 2010).Google Scholar
43. Elliot, G. Janet's repentance. In: Elliot, G.Scences of Clerical Life. London: Wordsworth Editions; 2007;279.Google Scholar
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