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Helsinki discord? A controversial declaration

In this article Brian Vastag looks at the initial mixed response to the October 2000 revision of the Declaration of Helsinki, in particular those provisions relating to the use of placebos and the availability of therapies to participants after research is over.

The views range from enthusiastic support — Delon Human, Secretary General of the World Medical Association suggests that the revision is an ideal that sets an ethical standard "which I don’t think can be set high enough" — through to disapproval — Robert Temple MD, director of the FDA’s Office of Drug Evaluation comments, "I think it’s scientifically and ethically incorrect".

The article goes on to outline ongoing controversies about what standards of care are ethical in research in developing countries. It concludes that while the question of who should meet the costs of satisfying the Declaration's requirements is unclear, the revised Declaration provides developing countries with "the leverage to demand more consideration from medical researchers".

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