Intended for healthcare professionals

Education And Debate

For and againstDeclaration of Helsinki should be strengthenedForAGAINSTRothman and Michels' riposte

BMJ 2000; 321 doi: (Published 12 August 2000) Cite this as: BMJ 2000;321:442

Declaration of Helsinki should be strengthened

The World Medical Association is now debating the next revision of the Declaration of Helsinki. Kenneth Rothman and Karin Michels argue that critics of the declaration, notably the US Food and Drug Administration, are trying to give scientists greater latitude than the declaration allows. In particular, Rothman and Michels dispute the morality of performing placebo controlled trials when there is an existing accepted treatment, and they offer other suggestions to strengthen the protection of patients who participate in medical experiments. Michael Baum argues against their absolutism on this issue and against what he considers their anti-science stance


  1. Kenneth J Rothman (, professora,
  2. Karin B Michels, assistant professorb
  1. a Department of Epidemiology and Biostatistics, Boston University School of Public Health, Boston University Medical Center, Boston, MA 02118-2526, USA
  2. b Harvard Medical School Obstetrics and Gynecology Epidemiology Center, Brigham and Women's Hospital, Boston, MA 02115, USA
  3. Department of Surgery, University College London, London W1P 7LD
  1. Correspondence to: K J Rothman

    Actions that penalise some for the good of others are defended under the utilitarian banner of doing the greatest good for the greatest number. For this reason we justify imposing quarantine to prevent the spread of infectious illness. In the same spirit some scientists and regulators would ask patients who participate in medical research to make sacrifices for the greater good. Their position puts them at odds with the Declaration of Helsinki, which does not mince words in choosing between the greatest good for the greatest number and the rights of the individual patient: “In research on man, the interest of science and society should never take precedence over considerations related to the well being of the subject.”1 This ethical choice of the patient's rights over the good of society in general is now up for re-examination as the World Medical Association deliberates the next revision of the declaration.

    Under pressure from the FDA

    Why would the World Medical Association consider stepping back from its strong support for the rights of the patient? It is under pressure to do so from several critics, 2 3 notably the United States Food and Drug Administration. The Food and Drug Administration mandates many human experiments as part of the approval …

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