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Helsinki Discord? A Controversial Declaration
Brian Vastag
JAMA. 2000;284:2983-2985.
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WashingtonA long-awaited fifth revision of the Declaration of Helsinki, widely acknowledged as the foundation of medical research ethics, is receiving mixed reactions for discouraging placebos in clinical trials and mandating researchers to provide "best proven" therapy to participants after a trial.
Patient protection advocates, who lobbied hard for the new language, hail the revision as a major step toward abolishing what they see as unethical research, especially in developing nations. Delon Human, MD, secretary general of the World Medical Association (WMA), which put forth the declaration, is equally enthusiastic. He says the revision is an idealnot a "manual of protocols and procedures"but that it sets an ethical standard "which I don't think can be set high enough."
Or can it be? Some researchers and bioethicists are calling the recommendations on placebo use unwarranted and unnecessary, a possible bane to future research. And the US agencies responsible for . . . [Full Text of this Article]
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