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Closing the evidence gap in infectious disease: point-of-care randomization and informed consent

Leibovici, Leonard
Theuretzbacher, Ursula
Paul, Mical
Published in Clinical Microbiology and Infection. 2016
Abstract The informed consent document is intended to provide basic rights to patients but often fails to do so. Patients' autonomy may be diminished by virtue of their illness; evidence shows that even patients who appear to be ideal candidates for understanding and granting informed consent rarely are-particularly those with acute infections. We argue that, for low-risk trials whose purpose is to evaluate non-experimental therapies or other measures toward which the medical community is in a state of equipoise, ethics committees should play a more active role in a more standardized fashion. Patients in the clinic are continually subject to spontaneous "pseudo-randomizations" based on local dogma and the anecdotal experience of their physicians. Stronger ethics oversight would allow point-of-care trials to structure these spontaneous randomizations, using widely available informatics tools, in combination with opt-out informed consent where deemed appropriate.
PMID: 27497812
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Research group Groupe Harbarth Stephan (Staphylocoques dorés résistants à la méthicilline) (866)
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CSAKI HUTTNER, Angela et al. Closing the evidence gap in infectious disease: point-of-care randomization and informed consent. In: Clinical Microbiology and Infection, 2016. https://archive-ouverte.unige.ch/unige:87644

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Deposited on : 2016-09-21

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