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The placebo phenomenon and medical ethics: Rethinking the relationship between informed consent and risk–benefit assessment

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Abstract

It has been presumed within bioethics that the benefits and risks of treatments can be assessed independently of information disclosure to patients as part of the informed consent process. Research on placebo and nocebo effects indicates that this is not true for symptomatic treatments. The benefits and risks that patients experience from symptomatic treatments can be shaped powerfully by information about these treatments provided by clinicians. In this paper we discuss the implications of placebo and nocebo research for risk–benefit assessment and informed consent.

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Notes

  1. An argument providing detailed support for this interpretation has been developed elsewhere; see [17].

  2. For the sake of this analysis, the risks of vertebroplasty are intentionally left out of this hypothetical account of information disclosure.

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Acknowledgments

We thank Annette Rid, Reidar Lie, and Alan Wertheimer for helpful comments on previous drafts of this paper. This research was supported by the Intramural Research Program of the Clinical Center, NIH and the National Center for Complementary and Alternative Medicine.

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Authors and Affiliations

  1. Department of Bioethics Clinical Center, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD, 20892-1156, USA

    Franklin G. Miller & Luana Colloca

  2. National Center for Complementary and Alternative Medicine, National Institutes of Health, Bethesda, MD, USA

    Luana Colloca

Authors
  1. Franklin G. Miller
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  2. Luana Colloca
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Correspondence to Franklin G. Miller.

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The opinions expressed are the views of the authors and do not necessarily reflect the policy of the National Institutes of Health, the Public Health Service, or the U.S. Department of Health and Human Services.

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Miller, F.G., Colloca, L. The placebo phenomenon and medical ethics: Rethinking the relationship between informed consent and risk–benefit assessment. Theor Med Bioeth 32, 229–243 (2011). https://doi.org/10.1007/s11017-011-9179-8

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