American Journal of Bioethics 21 (5):46-58 (2021)

Authors
Joseph Millum
National Institutes of Health
Danielle Bromwich
University of Massachusetts, Boston
Abstract
Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials.
Keywords Informed consent  Disclosure  Understanding  clinical research  therapeutic misconception  valid consent
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DOI 10.1080/15265161.2020.1863511
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References found in this work BETA

Studies in the Way of Words.H. P. Grice - 1989 - Cambridge: Harvard University Press.
Autonomy and Trust in Bioethics.Onora O'Neill - 2002 - Cambridge University Press.
Rethinking Informed Consent in Bioethics.Neil C. Manson - 2007 - Cambridge University Press.

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Citations of this work BETA

The Grounds of the Disclosure Requirement for Informed Consent.Tom Dougherty - 2021 - American Journal of Bioethics 21 (5):68-70.
Varieties of Minimalism About Informed Consent.Gopal Sreenivasan - 2021 - American Journal of Bioethics 21 (5):66-68.
Informed Consent, Understanding, and Trust.David B. Resnik - 2021 - American Journal of Bioethics 21 (5):61-63.

View all 10 citations / Add more citations

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