• We are sorry, but NCBI web applications do not support your browser and may not function properly. More information
Logo of jmedethJournal of Medical EthicsVisit this articleSubmit a manuscriptReceive email alertsContact usBMJ
J Med Ethics. Apr 2004; 30(2): 190–193.
PMCID: PMC1733825

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

Abstract

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.

Full Text

The Full Text of this article is available as a PDF (149K).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.
  • Angell M. The ethics of clinical research in the Third World. N Engl J Med. 1997 Sep 18;337(12):847–849. [PubMed]
  • Annas GJ, Grodin MA. Human rights and maternal-fetal HIV transmission prevention trials in Africa. Am J Public Health. 1998 Apr;88(4):560–563. [PMC free article] [PubMed]
  • Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med. 1997 Sep 18;337(12):853–856. [PubMed]
  • Schuklenk U, Ashcroft R. International research ethics. Bioethics. 2000 Apr;14(2):158–172. [PubMed]
  • Varmus H, Satcher D. Ethical complexities of conducting research in developing countries. N Engl J Med. 1997 Oct 2;337(14):1003–1005. [PubMed]
  • Ellenberg SS, Temple R. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: practical issues and specific cases. Ann Intern Med. 2000 Sep 19;133(6):464–470. [PubMed]
  • Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues. Ann Intern Med. 2000 Sep 19;133(6):455–463. [PubMed]
  • Brennan TA. Proposed revisions to the Declaration of Helsinki--will they weaken the ethical principles underlying human research? N Engl J Med. 1999 Aug 12;341(7):527–531. [PubMed]
  • Guenter D, Esparza J, Macklin R. Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS). J Med Ethics. 2000 Feb;26(1):37–43. [PMC free article] [PubMed]
  • Abdool Karim SS. Placebo controls in HIV perinatal transmission trials: a South African's viewpoint. Am J Public Health. 1998 Apr;88(4):564–566. [PMC free article] [PubMed]

Articles from Journal of Medical Ethics are provided here courtesy of BMJ Group

Formats:

Related citations in PubMed

See reviews...See all...

Cited by other articles in PMC

See all...

Links

  • PubMed
    PubMed
    PubMed citations for these articles

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...