A REDCap-based Model for Electronic Consent (eConsent): Recruitment Innovation Center Support for Reaching Communities During a Pandemic

Abstract

Introduction:
During the COVID-19 pandemic, many research participants cannot be consented in person, thereby making it critical to have a consent document that provides a clear presentation of key information to help someone make a decision about study participation. We utilized a community-engaged approach to technology development to inform features within the REDCap software platform to support electronic consent (eConsent) transactions. eConsent can be used for remote protocols which may improve recruitment and retention in clinical research studies, particularly during the pandemic by addressing: 1.) barriers for accessing populations by facilitating remote consent; and 2.) cultural and literacy barriers by including optional, in-line, definitions of medical terms or the choice of displaying different videos/images which could enhance the consenting experience for participants of diverse racial backgrounds, ethnicities and/or education levels.
Methods:
eConsent features centered around presentation of information, transparency, clinical trial efficiency, and regulatory compliance related to collection and long-term storage of informed consent documentation. We developed and tested our 21 CFR 11 compliant eConsent framework to provide a personalized consent experience through a consent document that utilizes avatars, information supplements, to provide additional explanation, and videos, to facilitate communication of information. The eConsent framework is being piloted in several large, multi-center trials to support remote consent of rural and/or high-risk participants (PREVENTABLE) and contactless consent for COVID-19+ patients (ORCHID).
Results:
The eConsent framework was made available to the REDCap Consortium in March of 2018 and saw enormous growth with the start of the pandemic, going from 140,000 eConsent transactions REDCap Consortium-wide (March 2020) to >728,600 transactions (October 2020). eConsent has been utilized for its ability to customize content to support participant understanding of the consent, but also to help with patient and study team safety via “contactless” or remote consenting.
Conclusions:
The Recruitment Innovation Center (RIC) has supported Pilot testing of the eConsent framework has demonstrated acceptability for large multi-center trials. Next steps will emphasize enhancements to improve participant engagement with the consent process including updates to the multi-lingual module to support consenting in non-English languages.

Authors
Colleen
Lawrence
Manager, Translational Research
Paul
Harris
Professor of Biomedical Informatics
Consuelo
Wilkins
Executive Director, Meharry Vanderbilt Alliance