title: Closing the evidence gap in infectious disease: point-of-care randomization and informed consent.
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.
authors: Infection Control Program, Switzerland; Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland. Electronic address: angela.huttner@hcuge.ch.
authors: A
authors: A
authors: Huttner
authors: Sackler Faculty of Medicine, Tel-Aviv University, Ramat-Aviv, Israel Department of Medicine E, Rabin Medical Centre, Beilinson Hospital, Petah-Tikva, Israel.
authors: L
authors: L
authors: Leibovici
authors: Center for Anti-Infective Agents, Vienna, Austria.
authors: U
authors: U
authors: Theuretzbacher
authors: Infection Control Program, Switzerland; Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
authors: B
authors: B
authors: Huttner
authors: Division of Infectious Diseases, Rambam Health Care Campus, The Ruth and Bruce Rappaport Faculty of Medicine, Technion, Israel Institute of Technology, Haifa, Israel.
authors: M
authors: M
authors: Paul
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards; D003141:Communicable Diseases / Q000175:diagnosis* / Q000628:therapy*; D006801:Humans; D007258:Informed Consent; D019095:Point-of-Care Systems; D011897:Random Allocation; D012107:Research Design
keywords: Ethics committee; Learning healthcare system; Opt-out informed consent; Point-of-care randomization; Point-of-care trial