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More Information on Ethics and Clinical Trials

Letter in the Washington Post on Modifications to the Declaration of Helsinki

This letter to the editor, by Health Research Group Deputy Director Peter Lurie, M.D., M.P.H. and Director Sidney Wolfe, M.D., appeared in the Washington Post on October 17, 2000.

Protecting Patients In Medical Research

The real story behind the revised research ethics document known as the Declaration of Helsinki [news story, Oct. 8] is that the declaration was reopened with the specific intent of watering it down so that patients in experiments in poor countries would not have to be provided with the best scientifically proven therapies. Early drafts of the revision required only that a patient be provided interventions "that would otherwise be available to him or her." But hundreds of physicians, researchers and advocates from around the world criticized that language, and, as a result, the declaration has reverted to requiring that the best-proven interventions be provided to those in comparison groups during the study.

This two-year process gave those who would weaken the Declaration of Helsinki more than ample opportunity to make their case, and it was squarely rejected. From now on researchers will have no choice but to provide scientifically proven interventions-regardless of where the research is conducted.

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