Closing the evidence gap in infectious disease: point-of-care randomization and informed consent. (February 2017)

• Record Type: Journal Article
• Authors: Huttner, A.; Leibovici, L.; Theuretzbacher, U.; Huttner, B.; Paul, M.
• Is Part Of: Clinical microbiology and infection. Volume 23:Number 2(2017)
• Page Start: 73
• Page End: 77
• Publication Date: 2017-02
• Subjects: Ethics committee -- Learning healthcare system -- Opt-out informed consent -- Point-of-care randomization -- Point-of-care trial; Medical microbiology -- Periodicals; Diagnostic microbiology -- Periodicals; Communicable diseases -- Periodicals; Infection -- Periodicals; 616.01
• DOI: 10.1016/j.cmi.2016.07.029
• Languages: English
• ISSNs: 1198-743X

Abstract

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.