FDA abandons Declaration of Helsinki for international clinical trials

FDA abandons Declaration of Helsinki for international clinical trials
June 1st, 2008 by bronxdoc
At the end of April the US Food and Drug Administration (FDA) published a regulatory change ending the need for clinical trials conducted outside of the US to comply with the Declaration of Helsinki. The FDA’s decision had been in the making for several years and is a major victory of corporate interests which have sought to loosen the ethical standards for international clinical trials. Integrity in Science has written a critique of this decision in which Peter Lurie of Public Citizen’s Health Research Group is quoted as saying that it is “in line with other U.S. efforts to flout international mores.” [Lurie had made a detailed critique of the proposal in the Lancet in 2005.]/.../