Supporting Patients in Managing Electronic Health Records and Biospecimens Consent for Research: Insights from a Mixed-Methods Usability Evaluation of the iAGREE Portal

TL;DR

This study evaluates the usability of iAGREE, a patient-centered portal for managing consent to share health data and biospecimens, highlighting positive feedback and areas for improvement to enhance informed consent processes.

Contribution

The paper introduces and assesses the usability of iAGREE, a novel, user-friendly platform for granular patient consent management in health research.

Findings

High usability ratings for iAGREE

Participants suggested actionable improvements

Insights to guide future consent tool designs

Abstract

De-identified health data are frequently used in research. As AI advances heighten the risk of re-identification, it is important to respond to concerns about transparency, data privacy, and patient preferences. However, few practical and user-friendly solutions exist. We developed iAGREE, a patient-centered electronic consent management portal that allows patients to set granular preferences for sharing electronic health records and biospecimens with researchers. To refine the iAGREE portal, we conducted a mixed-methods usability evaluation with 40 participants from three U.S. health systems. Our results show that the portal received highly positive usability feedback. Moreover, participants identified areas for improvement, suggested actionable enhancements, and proposed additional features to better support informed granular consent while reducing patient burden. Insights from this study may inform further improvements to iAGREE and provide practical guidance for designing patient-centered consent management tools.