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Title

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

Authors
Leibovici, Leonard
Theuretzbacher, Ursula
Paul, Mical
Published in Clinical Microbiology and Infection. 2017, vol. 23, no. 2, p. 73-77
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.
Identifiers
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, 2017, vol. 23, n° 2, p. 73-77. https://archive-ouverte.unige.ch/unige:87644

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Deposited on : 2016-09-21

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