Communication and Miscommunication in Informed Consent to Research

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Center for Bioethics Papers
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biomedical research
informed consent
biomedical language
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Biomedical ethics require that research subjects be aware that the drugs they take or procedures they undergo are designed to fulfill the conditions of the experiment and not to benefit a subject’s health. This apparently straightforward distinction between research and treatment is a source of much controversy and misunderstanding. Ethicists have labeled this problem the "therapeutic misconception." This misconception and, more broadly, informed consent have been studied extensively. Nonetheless, the therapeutic misconception persists among research subjects. This paper argues that one factor overlooked in the persistence of the therapeutic misconception is the effect of the theoretical paradigm that guides the practice and analysis of informed consent. The paradigm poses an idealized model of communication that ignores social context. This paper examines informed consent practices associated with a cancer research trial to demonstrate an alternative approach to studying informed consent to research. Through analysis of informed consent session transcripts, it demonstrates the importance of taking account of not only what is said, but how and by whom it is said.

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Reprinted from the Medical Anthropology Quarterly, Volume 18, Issue 4, December 2004, pages 429-446. Copyright 2004 by the Regents of the University of California/American Anthropological Association. Copying and permissions notice: Authorization to copy this content beyond fair use (as specified in Sections 107 and 108 of the U. S. Copyright Law) for internal or personal use, or the internal or personal use of specific clients, is granted by the Regents of the University of California/on behalf of the American Anthropological Association for libraries and other users, provided that they are registered with and pay the specified fee via Rightslink® on AnthroSource ( or directly with the Copyright Clearance Center,
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