Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care Journal Article


Authors: Vickers, A. J.; Young-Afat, D. A.; Ehdaie, B.; Kim, S. Y. H.
Article Title: Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care
Abstract: Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a “just-in-time” consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient’s burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants’ understanding of research procedures. © 2017, © The Author(s) 2017.
Keywords: randomized controlled trials; anxiety; informed consent; decisional burden; decisional conflict; pragmatic trials
Journal Title: Clinical Trials
Volume: 15
Issue: 1
ISSN: 1740-7745
Publisher: Sage Publications  
Date Published: 2018-02-01
Start Page: 3
End Page: 8
Language: English
DOI: 10.1177/1740774517746610
PROVIDER: scopus
PMCID: PMC5799028
PUBMED: 29224379
DOI/URL:
Notes: Article -- Export Date: 1 March 2018 -- Source: Scopus
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  1. Andrew J Vickers
    883 Vickers
  2. Behfar Ehdaie
    174 Ehdaie