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

A. Huttner, L. Leibovici, U. Theuretzbacher, B. Huttner, M. Paul

Research output: Contribution to journalReview articlepeer-review

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.

Original languageEnglish
Pages (from-to)73-77
Number of pages5
JournalClinical Microbiology and Infection
Volume23
Issue number2
DOIs
StatePublished - 1 Feb 2017

Keywords

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

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