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The CIOMS view on the use of placebo in clinical trials

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Abstract

Based on worldwide consultations with experts in science and ethics the revised CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects provide guidance on when the use of placebo as a comparator in clinical research is ethically acceptable. The article reviews the main points of the CIOMS Guidelines and commentaries including the use of placebo in situations where the best current method is available and the relation of placebo to established effective intervention. It discusses the use of placebo in externally sponsored research in low-resource countries and requirements for informed consent related to placebo studies.

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References

  1. CIOMS (2002) International Ethical Guidelines for Biomedical Research Involving Human Subjects, CIOMS, Geneva. ISBN 92 9036 075 5. Available on the Internet: www.cioms.ch

  2. Temple, R. & Ellenberg S.S. (2000) Placebo-controlled trials and active control trials in the evaluation of new treatments. Part 1: Ethical and scientific issues. Ann Int Med 133: 455–463.

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  3. Idänpään-Heikkilä JE (2001) Ethical principles for the guidance of physicians in medical research- the Declaration of Helsinki. Bull WHO 79: 279.

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  4. Emanuel E.J. & Miller F.G.: The ethics of placebo-controlled trials — A middle Ground. NEJM 345: 915–919.

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Authors and Affiliations

  1. Council for International Organizations of Medical Sciences (CIOMS), c/o World Health Organization, Avenue Appia, CH-1211, Geneva 27, Switzerland

    Juhana E. Idänpään-Heikkilä MD, PhD (Secretary-General) & Sev Fluss (Special Advisor)

Authors
  1. Juhana E. Idänpään-Heikkilä MD, PhD
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  2. Sev Fluss
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Correspondence to Sev Fluss.

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Idänpään-Heikkilä, J.E., Fluss, S. The CIOMS view on the use of placebo in clinical trials. SCI ENG ETHICS 10, 23–28 (2004). https://doi.org/10.1007/s11948-004-0058-9

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  • DOI: https://doi.org/10.1007/s11948-004-0058-9

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