Pulse Brain · Growing Health Evidence Index
Tier 3 — Observational / field trialPeer-reviewed

A REDCap-based model for electronic consent (eConsent): Moving toward a more personalized consent

Colleen Lawrence, Leah Dunkel, Mark A. McEver, Tiffany Israel, Robert J. Taylor, Germán Chiriboga, Karin Valentine Goins, Elizabeth J. Rahn, Amy S. Mudano, Erik D. Roberson, Carol Chambless, Virginia G. Wadley, Maria I. Danila, Melissa A. Fischer, Yvonne Joosten, Kenneth G. Saag, Jeroan J. Allison, Stephenie C. Lemon, Paul A. Harris

Journal of Clinical and Translational Science · 2020

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Summary

This pilot study describes the development and testing of a REDCap-based electronic consent framework designed to address barriers in informed consent processes for clinical research. The framework incorporates personalised features—including avatars, contextual glossaries, and videos—to improve accessibility for rural, culturally diverse, and lower-literacy populations. Early adoption demonstrated acceptability, though efficacy testing of individual features remains a priority for future work.

UK applicability

The eConsent framework and its approach to improving informed consent accessibility could inform UK clinical research governance and recruitment practices, particularly for underrepresented populations. Adoption would require alignment with UK research ethics committee requirements and NHS research governance frameworks.

Key measures

Portfolio of eight eConsent features; community stakeholder review; adoption and utilisation rates at two academic medical centres; participant acceptability

Outcomes reported

The study developed and pilot-tested an electronic consent (eConsent) framework integrated into REDCap software, evaluating acceptability through implementation at two academic medical centres. The framework was assessed for its capacity to improve participant engagement, transparency, and regulatory compliance in informed consent processes.

Theme
Policy, governance & rights
Subject
Other / interdisciplinary
Study type
Research
Study design
Pilot study with community-engaged technology development
Source type
Peer-reviewed study
Status
Published
Geography
United States
System type
Human clinical
DOI
10.1017/cts.2020.30
Catalogue ID
BFmoso8xrl-sgzbn9

Topic tags

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