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Informed consent process in the ISPY COVID trial is ethically acceptable

Published:September 30, 2022DOI:https://doi.org/10.1016/j.ejim.2022.09.019
      The ISPY COVID Investigators would like to respond to Dal-Re et al. in their recent editorial in on the ethics of the consent process in the ISPY COVID Trial [
      • 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.
      ]. Unfortunately, the authors of the editorial have fundamentally misunderstood the consent process, which is not described accurately in their editorial.
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      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
        • Files D.C.
        • Matthay M.A.
        • Calfee C.S.
        • et al.
        I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations.
        BMJ Open. 2022; 12e060664
        • Emanuel E.J.
        • Boyle C.W.
        Assessment of length and readability of informed consent documents for COVID-19 vaccine trials.
        JAMA Netw Open. 2021; 4e2110843