The standard of care debate: the Declaration of Helsinki versus the international consensus opinion.
The World Medical Association's revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors show that there is also consensus regarding the broad conditions under which this is acceptable.
Lie
R K
RK
Department of Public Health and Primary Health Care, University of Bergen, Bergen, Norway. Reidar.Lie@fil.uib.no
Emanuel
E
E
Grady
C
C
Wendler
D
D
D002986:Clinical Trials as Topic / Q000941:ethics*; D032921:Consensus; D003906:Developing Countries; D017408:Guidelines as Topic; D006381:Helsinki Declaration; D006805:Human Experimentation / Q000941:ethics; D006801:Humans; D038622:Internationality; D011787:Quality of Health Care / Q000941:ethics*; D012107:Research Design; D012307:Risk Factors; D012935:Social Justice / Q000941:ethics; D012955:Societies, Medical / Q000941:ethics