KYOTO — A leading world expert on medical ethics said Sunday that a strictly standardized Western approach to medical ethics should not be sought when humans are used in experiments with new drugs in other parts of the world.
The comments by Robert Levine, a professor of medicine at Yale University School of Medicine, are considered significant to pharmaceutical firms in developed countries that have begun conducting clinical testing of new drugs in developing countries.
Levine told a meeting of medical professionals in Kyoto that different approaches should be allowed when conducting clinical testing in non-Western parts of the world in view of the differences in ethical and cultural backgrounds.
For instance, a proxy’s consent, rather than direct consent from subjects, should be accepted in some African and Asian countries because many people there, particularly women, do not speak for themselves, he said.
Written informed consent taken directly from those participating in clinical experiments is required in the U.S. and Western Europe. Most countries in the West have laws stipulating the requirement.
In Japan, a guideline called “Good Clinical Practice” was revised in 1997 by the Health and Welfare Ministry to oblige doctors undertaking clinical trials at the request of pharmaceutical companies to secure written informed consent from patients.
Some clinical testing, including new methods for treating and preventing development of symptoms of human immunodeficiency virus, have been conducted in Africa because the area has the largest number of HIV and AIDS patients. But some experts in medical ethics have questioned such trials, saying they may exploit African patients.
Levine concedes that some may see the application of differing ethics as an altering of ethics for the sake of research. But he added that strict control is necessary to protect patients’ human rights.
Levine also stressed that new drugs developed by firms in industrialized countries but tested in developing countries should also be distributed in the developing country to ensure that subjects there also benefit from the drug instead of merely serving as test cases.
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