Helsinki's New Clinical Rules: Fewer Placebos, More Disclosure

After 3 years of intense debate, medical researchers and ethicists have agreed on international standards that would dramatically tighten the rules for clinical research and put new limitations on the risks to which patients may be exposed. Meeting in Edinburgh, U.K., on 7 October, the general assembly of the World Medical Association (WMA) gave a clear victory to patient-advocacy groups seeking a change in the way experimentation on humans is conducted. The WMA voted to approve a revised version of the 1964 Declaration of Helsinki, the cornerstone of clinical research ethics, that reduces ambiguity in existing guidelines and could force changes in the design of future drug trials.