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

Area of Science:

• Clinical Research Technology
• Informed Consent Process
• Human Subjects Protection

Background:

• The updated common rule mandates concise informed consent presentations for human subjects research.
• Electronic informed consent (eConsent) can enhance transparency, efficiency, and regulatory compliance.
• eConsent may overcome barriers to rural and diverse population participation in clinical trials.

Purpose of the Study:

• To develop and pilot test a community-engaged eConsent framework within the REDCap platform.
• To address issues of transparency, efficiency, and regulatory compliance in clinical trial informed consent.
• To explore eConsent's potential to improve recruitment and retention by addressing access and literacy barriers.

Main Methods:

• A community-engaged technology development approach informed feature options for the eConsent system.
• The eConsent framework was developed and pilot tested, incorporating avatars, glossary supplements, and videos.
• Eight features were developed, reviewed by community stakeholders, and tested at two academic medical centers.

Main Results:

• The eConsent framework includes a portfolio of eight features.
• Community stakeholders reviewed the features.
• The framework was pilot tested at two academic medical centers.

Conclusions:

• Early adoption and utilization of the eConsent framework demonstrate user acceptability.
• Future research will focus on testing the efficacy of eConsent features to enhance participant engagement.
• The developed eConsent system aims to improve the overall informed consent experience in clinical research.