J Med Ethics 30:194-197 doi:10.1136/jme.2003.006981
  • Research ethics

The standard of care debate: against the myth of an “international consensus opinion”

  1. U Schüklenk
  1. Correspondence to:
 Professor U Schüklenk
 Head, Division of Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, Wits 2050, South Africa;
  • Accepted 10 December 2003


It is argued by Lie et al in the current issue of the Journal of Medical Ethics that an international consensus opinion has formed on the issue of standards of care in clinical trials undertaken in developing countries. This opinion, so they argue, rejects the Declaration of Helsinki’s traditional view on this matter. They propose furthermore that the Declaration of Helsinki has lost its moral authority in the controversy in research ethics. Although the latter conclusion is supported by this author, it will be demonstrated in this paper that there is not such a thing as an international consensus opinion, and that the authorities used by Lie et al as evidence in support of their claim should not be relied upon as authorities or final arbiters in this debate. Furthermore, it will be shown that arguments advanced substantively to show that lower standards of care are ethically acceptable in the developing world, conflate scientific with economic reasons, and ultimately fail to bolster the case they are designed to support.


  • * Professor D B Greco (Brazil) was the coordinator of this meeting; the quote is taken from a personal communication sent by Greco on 10 December 2003.

  • I witnessed these attempts firsthand during a discussion held between leading members of the South African AIDS Vaccine Initiative and representatives of South African ethics committees in 2002, in Durban, South Africa.