J Med Ethics 30:190-193 doi:10.1136/jme.2003.006031
  • Research ethics

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

  1. R K Lie1,2,
  2. E Emanuel2,
  3. C Grady2,
  4. D Wendler2
  1. 1Department of Public Health and Primary Health Care, University of Bergen, Bergen, Norway
  2. 2Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD, USA
  1. Correspondence to:
 Professor R Lie
 Department of Public Health and Primary Health Care, Kalfarveien 31, University of Bergen, Bergen, Norway;
  • Received 26 July 2003
  • Accepted 21 October 2003
  • Revised 11 September 2003


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.


  • The opinions expressed are the authors’ own. They do not reflect any position or policy of the National Institutes of Health, Public Health Service, or Department of Health and Human Services.