- © 2004 Canadian Medical Association or its licensors
Your editorial about the Helsinki Declaration1 was probably the first indication of unequivocal support from a developed country for the developing countries' cry for justice, even if only (but hopefully just for the time being) in the arena of clinical trials.
As a researcher and concerned physician in Brazil, I agree with your evaluation of the crucial role of the Declaration of Helsinki in setting ethical standards for human research. In fact, its ethical framework has become a benchmark in this area and has become, on its own merits, a standard not just of the World Medical Association (WMA) but also for society as a whole.
While we researchers are generally privileged people, many research subjects are among the most vulnerable, living under conditions of deprivation and prone to exploitation. Many trials are performed in extremely poor regions of the world, with the questionable justification that these communities are in urgent need of answers to specific research questions. Such “specific questions” could undoubtedly be answered elsewhere. Furthermore, the vulnerability of these potential research subjects makes it almost impossible for meaningful informed consent to be obtained, and their extreme poverty makes it highly unlikely that the products of the research will be accessible to them. What people in developing countries really need is access to products that have been researched and developed and are in use elsewhere.
In addition to the opposition of the Argentinean and Brazilian medical associations to the changes in paragraph 30 (access to medical care) and the addition of notes of clarification, Brazil also opposed the confused and lax note of clarification to paragraph 29. This note was discussed in a petit comité meeting convened by the WMA in September 2001 but was defeated by representatives of the pharmaceutical industry and regulatory agencies and researchers from the United States.
The WMA postponed any modification or note of clarification to paragraph 30 and established a new working group for this discussion. Although this group is skewed in its representation, 2 of the 5 countries represented are from the developing world (Brazil and South Africa). Brazil's position is clear: any change in the Declaration of Helsinki should be made only if there are compelling reasons to do so. And in this unequal world, we argue that any modification should be in the direction of making the ethical obligations of providing adequate access to medical care even more stringent, to be applied to every trial involving a human being, wherever such a trial is performed.
Dirceu B. Greco Professor, Internal Medicine Coordinator, Infectious Diseases Service Federal University of Minas Gerais Belo Horizonte, Brazil
Reference
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