Abstract
It is argued by Lie et al in the current issue of the Journal of Medical Ethics that an international consensus opinion has formed on the issue of standards of care in clinical trials undertaken in developing countries. This opinion, so they argue, rejects the Declaration of Helsinki's traditional view on this matter. They propose furthermore that the Declaration of Helsinki has lost its moral authority in the controversy in research ethics. Although the latter conclusion is supported by this author, it will be demonstrated in this paper that there is not such a thing as an international consensus opinion, and that the authorities used by Lie et al as evidence in support of their claim should not be relied upon as authorities or final arbiters in this debate. Furthermore, it will be shown that arguments advanced substantively to show that lower standards of care are ethically acceptable in the developing world, conflate scientific with economic reasons, and ultimately fail to bolster the case they are designed to support.
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Selected References
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- Friele Minou Bernadette. Do committees ru(i)n the bio-political culture? On the democratic legitimacy of bioethics committees. Bioethics. 2003 Aug;17(4):301–318. doi: 10.1111/1467-8519.00347. [DOI] [PubMed] [Google Scholar]
- Lie R. K., Emanuel E., Grady C., Wendler D. The standard of care debate: the Declaration of Helsinki versus the international consensus opinion. J Med Ethics. 2004 Apr;30(2):190–193. doi: 10.1136/jme.2003.006031. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Lurie P., Wolfe S. M. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med. 1997 Sep 18;337(12):853–856. doi: 10.1056/NEJM199709183371212. [DOI] [PubMed] [Google Scholar]
- Schüklenk U. Protecting the vulnerable: testing times for clinical research ethics. Soc Sci Med. 2000 Sep;51(6):969–977. doi: 10.1016/s0277-9536(00)00075-7. [DOI] [PubMed] [Google Scholar]
- Schüklenk Udo, Ashcroft Richard E. Affordable access to essential medication in developing countries: conflicts between ethical and economic imperatives. J Med Philos. 2002 Apr;27(2):179–195. doi: 10.1076/jmep.27.2.179.2989. [DOI] [PubMed] [Google Scholar]