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Ethics of research in developing countries
We have previously drawn attention1 to evolving international research ethics and standards of care to be applied by Western researchers carrying out drug trials in developing countries. The non-provision in HIV vaccine trials of antiretroviral regimes to reduce mother-to-child transmission has been at the centre of debate. Some think that in its revised Helsinki Declaration,2 the World Medical Association (WMA) leaves the issue open to interpretation. The WMA says that “the benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current methods”. This can be read as supporting a universal standard of care regardless of the research location, to prevent exploitation of poor patients. In April 2002, however, the UK Nuffield Council on Bioethics published a thoughtful report arguing the contrary. While stressing the fundamental ethical principle that advantage must not be taken of the vulnerabilities created by poverty and poor resources, it said that insisting upon a universal standard of care was not the way to respect that principle. The Ethics of Research Related to Healthcare in Developing Countries,3 argues that standards of care can vary and should be defined in consultation with local people. Recommending that externally funded research should provide the level of care that is averagely available in that setting, it also envisages exceptional cases where an even lower standard would be permissible for the control group. An example is where research is to demonstrate that the best locally available treatments are ineffective or harmful. The WMA has issued one clarification note regarding Helsinki. It may now consider another to define “best current methods”.
South Africa and antiretrovirals—a change of heart
In April 2002, South Africa dramatically reversed its AIDS policy, announcing universal access to AIDS prophylactics for mother-to-child transmission of HIV. Previously, President Mbeki and Health Minister Tshabalala-Msimang had been notoriously …
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