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‘Time out’—more transparency is required in ‘Just-in-time’ consent

  • Rafael Dal-Ré
    Correspondence
    Corresponding author at: Unidad de Epidemiología, Instituto de Investigación Sanitaria-Hospital Universitario Fundación Jiménez Díaz, Universidad Autónoma de Madrid, Avda. Reyes Católicos 2, E-28040 Madrid, Spain.
    Affiliations
    Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Avda. Reyes Católicos 2, E-28040 Madrid, Spain
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  • Arthur L Caplan
    Affiliations
    Division of Medical Ethics, Grossman School of Medicine, NYU Langone Medical Center, 550 1st Ave., New York, NY 10016, United States
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  • Teck Chuan Voo
    Affiliations
    Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, Clinical Research Centre, National University of Singapore, 21 Lower Kent Ridge Rd 117597, Block MD11, #02-03, 10 Medical Drive, Singapore 119077, Singapore
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Published:November 29, 2022DOI:https://doi.org/10.1016/j.ejim.2022.11.031
      Vickers believes that a couple of statements contained in our article [
      • Dal-Ré R.
      • Caplan A.L.
      • Voo T.C.
      Participants’ informed consent in adaptive, platform drug trials in hospitalized COVID-19 patients: not all approaches are ethically acceptable.
      ] are ‘grossly erroneous’ [
      • Vickers A.
      Inaccurate description of staged consent.
      ]. One is that the control group participants of Just-in-time consent “would not know that their assignment was made by a random process”. The second is that Just-in-time consent does not “fulfil the three following ethical features: participants must agree to contribute to the trial, this must be known at the time they are recruited, and they must know that they have participated in it.” [
      • Vickers A.
      Inaccurate description of staged consent.
      ]. We disagree with Vickers. We believe that from the article he co-authored [
      • Vickers A.J.
      • Young-Afat D.A.
      • Ehdaie B.
      • Kim S.Y.
      Just-in-time consent–the ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.
      ], which we used as a reference for our article [
      • Dal-Ré R.
      • Caplan A.L.
      • Voo T.C.
      Participants’ informed consent in adaptive, platform drug trials in hospitalized COVID-19 patients: not all approaches are ethically acceptable.
      ], our two statements are correct.

      Keywords

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