Education And Debate

What are the effects of the fifth revision of the Declaration of Helsinki?Fair partnerships support ethical researchGains and losses for rights of consumer and research participantsResearch will be impededSome clauses will hinder development of new drugs and vaccines

BMJ 2001; 323 doi: (Published 15 December 2001) Cite this as: BMJ 2001;323:1417

What are the effects of the fifth revision of the Declaration of Helsinki?

The World Medical Association's fifth revision of the Declaration of Helsinki strives to strike a balance between ensuring high ethical standards and retaining sufficient sensitivity to local circumstances, especially in developing world research, to avoid thwarting research with bureaucracy. Has the balance been achieved? We asked researchers working in the developing world, the developed world, and the pharmaceutical industry, as well as a patient representative, to comment.

Fair partnerships support ethical research

  1. Stephen M Tollman, associate professor (
  1. School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Parktown 2193, South Africa
  2. Cochrane Collaboration Consumer Network, PO Box 96, Burwood, Vic 3125, Australia
  3. Clinical Trial Service Unit and Epidemiological Studies Unit, Harkness Building, Radcliffe Infirmary, Oxford OX2 6HE
  4. Merck Research Laboratories, 126 East Lincoln Avenue, RY33-728, Rahway, NJ 07065, USA

    The World Medical Association describes the Declaration of Helsinki as a statement of ethical principles to guide physicians and other participants in medical research involving human subjects, including identifiable human tissue or data.1 When producing the fifth revision, representatives of the 71 affiliated medical associations were especially concerned that research in developing settings—and particularly clinical trials—meet the highest ethical standards of conduct. However, despite the increasingly inclusive aspirations of the revised declaration, some of the absolute and exclusionary language could unintentionally endanger research in developing countries.

    Use of placebo controlled trials

    One of the fundamental changes to the declaration is clause 29. This states that new treatments should be tested against best current treatment rather than placebo (box). The clause was formulated in response to sustained criticism of field trials in developing countries that tested short course therapies aimed at preventing vertical transmission of HIV using placebo controls.24 It implies that local circumstances—sociopolitical, financial, infrastructural, cultural—can never justify failure to use the best known drugs or technologies in the control arm. Its intention is clear:

    Clause 29 of the Declaration of Helsinki

    The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.

    • To ensure that the interests of trial subjects, no matter where they live, …

    Correspondence to: L J Hirsch

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