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The Declaration of Helsinki

BMJ 2007; 335 doi: (Published 27 September 2007) Cite this as: BMJ 2007;335:624
  1. Michael D E Goodyear, assistant professor of medicine1,
  2. Karmela Krleza-Jeric, clinical research officer2,
  3. Trudo Lemmens, associate professor, faculties of law and medicine3
  1. 1Dalhousie University, Halifax, Nova Scotia, Canada B3H 2Y9
  2. 2Canadian Institutes of Health Research, Ottawa, Ontario, Canada K1A 0W9
  3. 3University of Toronto, Toronto, Ontario, Canada M5S 2C5
  1. mgoodyear{at}

    Mosaic tablet, dynamic document, or dinosaur?

    The Declaration of Helsinki is a respected institution and one of the most influential documents in research ethics,1w1-w7 having withstood five revisions and two clarifications since its conception in 1964. Its guardian, the World Medical Association, recently invited submissions for further revision.2

    The history of the declaration has been well documented.3 4 5 The Nuremberg Code (1947) was one of the first statements of the ethical principles involved in human experimentation.w8 However, because of its association with Nazi war crimes it had relatively little effect on practice.w9 The Declaration of Helsinki dealt with clinical research more directly, but was portrayed as a weakening of the stringent protections of Nuremberg. Nevertheless, for a quarter of a century only minor changes were made and it became engrained in the international culture of research ethics.

    In 1996, the declaration added a reference to placebos in response to concerns about trials in perinatal HIV transmission in developing countries. Critics pointed out that continuing to use placebos when efficacy had been demonstrated implied a different ethical standard for developing countries than for developed ones. Having entered into the specifics of trial design the declaration was drawn into a debate on whether ethical principles are …

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