Using Evidence-Informed Practices to Improve eConsent

Authors: Annie B. Friedrich, PhD, Erin D. Solomon, PhD, Jessica Mozersky, PhD, & James M. DuBois, DSc, PhD

Author affiliation (all authors): Bioethics Research Center, Washington University School of Medicine, St. Louis, MO, USA

With funding from the National Institutes of Health, our team at Washington University School of Medicine developed an online toolkit, ConsentTools.org, to make consent processes in clinical trials more effective and efficient. It shares information, resources, brief videos, and tools to help clinical research professionals implement several evidence-informed consent practices. These include:

  • Using plain language
  • Using appropriate formatting
  • Assessing for understanding

Randomized controlled trials demonstrated that using these practices can increase participants’ understanding and appreciation of consent information.[1, 2] In this blog post, we explore how to adapt these practices when using eConsent in clinical trials.

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Research Recruitment Study – MyChart Message Recruitment

Andrew Snyder MBA, PMP, FACMPE

One of the most common challenges of conducting clinical trials is related to problems with recruitment.   Insufficient or untimely patient recruitment for clinical trials may have serious consequences.   The length of the study may be extended, leading to increased costs and staffing concerns.   Trials that do not recruit the required number of patients may impact the data integrity.  Study teams that cannot recruit patients may not be invited to participate in future studies by industry partners or may have difficulty securing future grants.   In some cases, a trial may have to be terminated resulting in unpublishable results, poor financial outcomes, and disappointed stakeholders.

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