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Informed consent process in the I-SPY COVID trial is questionable

  • 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, USA
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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:October 22, 2022DOI:https://doi.org/10.1016/j.ejim.2022.10.011
      We read with interest the letter by Files et al. [
      • Files D.C.
      • et al.
      Informed consent process in the ISPY COVID trial is ethically acceptable.
      ] commenting on our recently published article in which we discussed the inappropriateness of randomizing trial participants before obtaining their informed consent [
      • 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.
      ]. The I-SPY COVID Trial investigators claim that we have “fundamentally misunderstood the consent process” utilized [
      • Files D.C.
      • et al.
      Informed consent process in the ISPY COVID trial is ethically acceptable.
      ].

      Keywords

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      References

        • Files D.C.
        • et al.
        Informed consent process in the ISPY COVID trial is ethically acceptable.
        Eur J Intern Med. 2022; https://doi.org/10.1016/j.ejim.2022.09.019
        • 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.
        • Aggarwal N.R.
        • Asare A.L.
        • Beitler J.R.
        • et al.
        I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations.
        BMJ Open. 2022; 12e060664
        • I-SPY COVID Consortium
        Clinical trial design during and beyond the pandemic: the I-SPY COVID trial.
        Nat Med. 2022; 28: 9-11
      1. Code of Federal Regulations, 21CFR50.27. Informed consent of human subjects. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.27.