Summary
This paper describes a community-engaged development process for an electronic consent framework within REDCap that aims to personalise the informed consent experience for clinical research participants. The framework incorporates eight features—including avatars, contextual glossaries, and culturally/educationally tailored videos—designed to address barriers in consent comprehension, accessibility for rural populations, and regulatory compliance with updated common rule requirements. Early pilot testing at two academic medical centres demonstrated acceptability, with future work planned to evaluate the efficacy of individual features in improving participant engagement.
UK applicability
The eConsent framework addresses fundamental informed consent challenges applicable to UK clinical research governance and Good Clinical Practice standards. However, direct adoption would require adaptation to UK regulatory frameworks (Research Ethics Committee approval processes) and NHS integration infrastructure, and the acceptability findings from US academic medical centres may not fully translate to UK healthcare settings.
Key measures
Acceptability of eConsent framework features (avatars, contextual glossary, videos); community stakeholder review; implementation testing at two academic medical centres
Outcomes reported
The study describes the development and pilot testing of an electronic consent (eConsent) framework integrated into REDCap software, measuring acceptability through early adoption and utilisation at two academic medical centres. The framework was assessed for its capacity to improve participant engagement, transparency, clinical trial efficiency, and regulatory compliance.
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