Making clinical trials more patient-centered using digital interactive e-consent tools

Making clinical trials more patient-centered using digital interactive e-consent tools
Barbara Bowles Biesecker, Melissa R. Raspa, Douglas J. Rupert, Rebecca Munch Moultrie, Robert D. Furberg, Lauren A. McCormack
Occasional Paper, RTI International (published by RTI Press), October 2019
Open Access
Abstract
Research participants are required to give their consent to participate in clinical trials and nonexempt government-funded studies. The goal is to facilitate participant understanding of the intent of the research, its voluntary nature, and the potential benefits and harms. Ideally, participants make an informed choice whether to participate; one that is based on having sufficient relevant knowledge and that is consistent with their values and preferences. Achieving this objective can be challenging, and as such, many scholars have declared the consent process flawed or “broken.” Moreover, clinical trials are complex studies, and compelling evidence suggests that current consent processes are inadequate in achieving informed choice. E-consent offers a dynamic, engaging consent delivery mode that can effectively support making informed decisions about whether to participate in a trial.

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