Summary
This pilot study describes the development of a personalised electronic consent (eConsent) framework within REDCap software, informed by community engagement, to address regulatory compliance and improve informed consent processes in human subjects research. The framework incorporates avatars, contextual glossaries, and participant-specific videos to facilitate comprehension and reduce barriers for rural, culturally diverse, and lower-literacy populations. Early testing at two academic medical centres demonstrated acceptability of the eight-feature portfolio, with future work planned to assess efficacy in improving participant engagement.
UK applicability
The methodology and findings are applicable to UK clinical research governance, particularly as the Health and Social Care Act and Research Ethics Committee standards increasingly emphasise transparency and accessibility in informed consent. However, adaptation would be needed to reflect UK-specific regulatory frameworks (such as the Research Ethics Committee requirements) and NHS digital infrastructure constraints.
Key measures
Early adoption rates, utilisation metrics, and acceptability of eight eConsent framework features at two academic medical centres; community stakeholder review feedback
Outcomes reported
The study reports on the development and pilot testing of a REDCap-based electronic consent framework, and measures its acceptability through early adoption and utilisation at two academic medical centres. The framework incorporates eight features designed to personalise the consent experience and address barriers to recruitment and retention in clinical research.
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