RESEARCH ETHICS

The standard of care debate: the Declaration of Helsinki versus the international consensus opinion

R K Lie^1,2, E Emanuel², C Grady², D Wendler²

¹ Department of Public Health and Primary Health Care, University of Bergen, Bergen, Norway
² Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD, USA

Correspondence to:
Correspondence to:
Professor R Lie
Department of Public Health and Primary Health Care, Kalfarveien 31, University of Bergen, Bergen, Norway; Reidar.Lie{at}fil.uib.no

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.

Keywords: international research ethics; research ethics

Abbreviations: CIOMS, Council for International Organizations of Medical Sciences; NBAC, National Bioethics Advisory Commission; UNAIDS, United Nations Programme on HIV/AIDS; WMA, World Medical Association

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