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<p>Electronic consent (eConsent) has the potential to cost-effectively scale research recruitment and improve equity in access to research benefits, but it is unclear whether it achieves comparable informedness compared to traditional consent. In a randomized, controlled, non-inferiority trial (<i>N</i> = 604; <a href="http://clinicaltrials.gov">ClinicalTrials.gov</a> ID NCT04131062), we compared a human conversation-based consent process to an eConsent platform similar to that used by NIH’s All of Us Research Program and by studies conducted via Apple ResearchKit. Average comprehension scores of participants randomized to eConsent were non-inferior (<i>N</i> = 233; <i>M</i> = 85.8, <i>SD</i> = 14.7) to those randomized to traditional consent (<i>N</i> = 371; <i>M</i> = 76.5, <i>SD</i> = 22.3; <i>t</i>(600.6) = 9.51, <i>p</i> &lt; 0.001). One limitation was imbalance in the proportion of participants in each arm who initiated the survey via which we collected our outcome measures. Still researchers should give serious consideration to adoption of eConsent as an alternative or supplement to traditional consent. Indeed, the pattern of results we observed suggests that eConsent might yield more informed research enrollment decisions.</p>

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eConsent vs traditional consent among prospective biobank participants: a randomized study within a study trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月29日

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  • Randi L. Vogt-Yerem,
  • Patrick R. Heck,
  • Tamara Gjorgjieva,
  • Rebecca Mestechkin,
  • Daniel Rosica,
  • Anh Huynh,
  • Christopher F. Chabris,
  • H. Lester Kirchner,
  • John Wilbanks,
  • Megan Doerr,
  • Jennifer K. Wagner,
  • Michelle N. Meyer

摘要

Electronic consent (eConsent) has the potential to cost-effectively scale research recruitment and improve equity in access to research benefits, but it is unclear whether it achieves comparable informedness compared to traditional consent. In a randomized, controlled, non-inferiority trial (N = 604; ClinicalTrials.gov ID NCT04131062), we compared a human conversation-based consent process to an eConsent platform similar to that used by NIH’s All of Us Research Program and by studies conducted via Apple ResearchKit. Average comprehension scores of participants randomized to eConsent were non-inferior (N = 233; M = 85.8, SD = 14.7) to those randomized to traditional consent (N = 371; M = 76.5, SD = 22.3; t(600.6) = 9.51, p < 0.001). One limitation was imbalance in the proportion of participants in each arm who initiated the survey via which we collected our outcome measures. Still researchers should give serious consideration to adoption of eConsent as an alternative or supplement to traditional consent. Indeed, the pattern of results we observed suggests that eConsent might yield more informed research enrollment decisions.