Advertisement

Inaccurate description of staged consent

Published:November 18, 2022DOI:https://doi.org/10.1016/j.ejim.2022.11.019
      In their paper on the ethics of platform trials, Dal-Ré et al. [
      • 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.
      ] make two statements about “just-in-time” consent [
      • 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.
      ] (now more widely known as two-stage consent [
      • Vickers A.J.
      • Vertosick E.A.
      • Carlsson S.V.
      • Ehdaie B.
      • Kim S.Y.H.
      Patient accrual and understanding of informed consent in a two-stage consent design.
      ]). First, they claim that “control group participants in studies that employ ‘Just-in-time consent’ … would therefore not know that their assignment was made by a random process”. They go on to state that "Consent to RCTs should fulfil three 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.” The authors then allege that “‘Just-in-time consent’ … designs do not fulfil these three features for all participants."
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to European Journal of Internal Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • 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.
        Eur J Intern Med. 2022; 103: 1-3
        • 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.
        Clin Trials. 2018; 15: 3-8
        • Vickers A.J.
        • Vertosick E.A.
        • Carlsson S.V.
        • Ehdaie B.
        • Kim S.Y.H.
        Patient accrual and understanding of informed consent in a two-stage consent design.
        Clin Trials. 2021; 18: 377-382