An analysis of the study participant and study coordinator experience utilizing an electronic consent (eConsent) in REDCap

Abstract

Background The informed consent (IC) process offers an opportunity for researchers to promote participant autonomy and facilitate decision making. However, the traditional IC experience is often tedious, requiring study coordinators to present information in long IC documents. Paper IC documents can be difficult to understand and do not necessarily meet the needs of participants or study coordinators. The COVID‐19 pandemic underscores the need to provide an alternative to the in‐person, paper‐based IC process to minimize person‐to‐person contact. We worked with IRBs to revise how we engage and consent people in Alzheimer’s Disease Research Centers at the University of Wisconsin‐Madison and Emory University. Method In an ongoing effort to improve the IC process for adults at risk of developing memory and cognitive deficit, our team has been building and testing an electronic IC experience. We interviewed a total of 63 participants with a median age of 72. Participants underwent both the eConsent prototype and the paper consent. Seventy (70) percent of those participants preferred the eConsent over the traditional paper copy. We adapted into REDCap the electronic IC experience (eConsent). We collected input on the project from IRBs and study coordinators, and measured participant’s understanding of key elements of the IC through questions distributed throughout the eConsent. Results Each interested study participant received a unique link to the eConsent in REDCap. We observed which participants selected to review the eConsent information on their own, and which ones preferred to be guided remotely with the Study coordinators. We evaluated level of engagement with the eConsent and scored comprehension. The insights provided by this informed consent approach were used to determine whether it would be well suited for at‐home self‐administration across a diverse population. Conclusion Study participants and study coordinators alike prefer an electronic consent process and participants retain information better as opposed to the typical paper consent form. While the REDCap consent survey is a temporary solution for our study team, it is a cost‐effective solution that facilitates a better experience for the participants. We believe that this REDCap eConsent could be a beneficial solution for the virtual recruitment and consent process at other ADRC sites.

Perceptions of Research Burden and Retention Among Participants in ADRC Cohorts

“…One method to facilitate participant engagement is using an electronic consent experience. In a recent study, participants retained more information and preferred the electronic format compared with a typical paper consent 10. This approach could be integrated into existing studies to enhance participants’ understanding of research procedures and could potentially decrease participant (and investigator) burden.…”

“…In a recent study, participants retained more information and preferred the electronic format compared with a typical paper consent. 10 This approach could be integrated into existing studies to enhance participants' understanding of research procedures and could potentially decrease participant (and investigator) burden. Retention strategies such as these have been identified as key to minimizing dropout and facilitating long-term participation.…”