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Declaration of Helsinki should be strengthened

BMJ 2001; 322 doi: (Published 03 February 2001) Cite this as: BMJ 2001;322:299

Equipoise is essential principle of human experimentation

  1. R J Lilford, professor of research of public health and epidemiology. (,
  2. Benjamin Djulbegovic, associate professor of oncology and medicine
  1. University of Birmingham, Birmingham B15 2TT
  2. H Lee Moffitt Cancer Centre and Research Institute at the University of South Florida, Division of Blood and Bone Marrow Transplant, Tampa, FL 33612, USA
  3. University of the Witwatersrand, Faculty of Health Sciences, Parktown 2193, Johannesburg, South Africa
  4. Department of Epidemiology and Biostatistics, Boston University School of Public Health, Boston University Medical Center, Boston, MA 02118-2526, USA
  5. Harvard Medical School Obstetrics and Gynecology Epidemiology Center, Brigham and Women's Hospital, Boston, MA 02115, USA

    EDITOR—We wish to join in the debate about the next revision of the Declaration of Helsinki and to address some of the arguments put forward by Rothman et al.1

    We agree with Rothman and Michels that equipoise (“the uncertainty principle”2) is an essential ingredient of an ethical experiment and that the declaration should be amended to say so. We recently argued that extraordinary care should be given to understand and protect this fundamental principle, on which nearly the entire system of human experimentation stands.3

    Baum writes of “tensions between conduct of a trial and the autonomy of the individual.”1 This involves the notion that patients who participate in trials are asked to make a sacrifice for the good of others. This concern, however, is alleviated by explicitly invoking equipoise as the principle on which randomised controlled trials are based. The uncertainty principle states that a patient should be enrolled in a randomised controlled trial only if uncertainty about which of the trial treatments would benefit the patient most is so substantial that they are in equipoise or “indifferent” between treatment options. …

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