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Clin Microbiol Infect. 2017 Feb;23(2):73-77. doi: 10.1016/j.cmi.2016.07.029. Epub 2016 Aug 3.

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

Author information

1
Infection Control Program, Switzerland; Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland. Electronic address: angela.huttner@hcuge.ch.
2
Sackler Faculty of Medicine, Tel-Aviv University, Ramat-Aviv, Israel Department of Medicine E, Rabin Medical Centre, Beilinson Hospital, Petah-Tikva, Israel.
3
Center for Anti-Infective Agents, Vienna, Austria.
4
Infection Control Program, Switzerland; Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
5
Division of Infectious Diseases, Rambam Health Care Campus, The Ruth and Bruce Rappaport Faculty of Medicine, Technion, Israel Institute of Technology, Haifa, Israel.

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 nonexperimental therapies or other measures towards 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.

KEYWORDS:

Ethics committee; Learning healthcare system; Opt-out informed consent; Point-of-care randomization; Point-of-care trial

PMID:
27497812
DOI:
10.1016/j.cmi.2016.07.029
[Indexed for MEDLINE]
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