Towards a global implementation of eConsent in clinical trials

The informed consent process is the cornerstone of ethical clinical research and has incredibly evolved towards the years and the centuries. However, traditional paper-based informed consent places many burdens on study teams, especially during the pandemic of Covid-19, and is often difficult for clinical trial participants to understand. The electronic informed consent (eConsent), with digital features and multimedia components, thus appeared as an attractive alternative to many of these problems.

The goal of this research project is to understand how eConsent is perceived and experienced by clinical research experts, how it can improve patient comprehension, reduce site burden as well as to identify areas of opportunities and challenges for future clinical trials.

Lou Guffroy will present and discuss the current literature, the development of a prospective questionnaire on eConsent experiences sent to +3000 clinical research experts in Belgium, The Netherlands and Luxembourg. The results and recommendations of the survey, addressed to 5 different stakeholders, next to expert interviews, will conclude this presentation.

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