The Ethics of Placebo Controls as per The Nuremberg Code, "the cornerstone of modern human experimentation ethics," was formulated shortly after World War II in response to Nazi atrocities. The World Health Organization adopted a version of the code in 1964 as the Declaration of Helsinki.

The declaration elevates concern for the health and rights of individual patients in a study over concern for society, for future patients, or for science. It asserts, "In any medical study, every patient -- including those of a control group, if any -- should be assured of the best proven diagnostic and therapeutic method." This statement effectively proscribes the use of a placebo as control when a "proven" therapeutic method exists.

The declaration also directs that a study that violates its precepts should not be accepted for publication.



New England Journal of Medicine Vol 331:394-398 August 11, 1994 Number 6 Publisher Harvard University