57 - Utilizing an Interactive Electronic Informed Consent (eIC) in REDCap

Background: The Informed Consent (IC) experience is often tedious requiring research participants to read long, complex documents. Researchers have looked for alternatives to the traditional IC experience using interactive electronic technology. We implemented and evaluated a participant-centered electronic IC (eIC) to engage and consent adults participating in longitudinal Alzheimer’s disease studies.

Methods: We worked with IRB, study coordinators, outreach specialists, and research participants to design an eIC for participation in Alzheimer’s Disease Research Centers at two different Universities. We included features such as graphics, self-pacing, meaningful engagement, and access to additional information on demand. We also interspersed ten comprehension questions throughout the eIC to keep participants engaged and allow them to self-assess their understanding. We adapted the eIC design into REDCap by uploading the images and text from our eIC prototype using the survey settings and electronic consent framework. REDCap is a web-based application developed by Vanderbilt University to capture data for clinical research. Each study participant who expressed interest was given a personalized link to access the eConsent in REDCap. We scored participants’ responses to the self-assessment questions to determine whether the eIC could be self-administered across a diverse population as an alternative to in-person, paper-based consent.

Results: 468 participants consented through the eIC including adults from populations traditionally underrepresented in research, older adults over 66, and adults diagnosed with mild cognitive impairment. Analysis of responses to self-assessment questions shows that the eIC effectively conveys complex study concepts. Over 85% of participants responded correctly to individual questions. Seventy-eight percent of participants obtained a perfect score, answering the 10 questions correctly. No participant had less than 6 correct answers, regardless of age or diagnosis of mild cognitive impairment. Study coordinators were able to see responses to the questions to tailor future discussions with the participants. They were also able to identify concepts that seemed more challenging to understand. These results can inform future improvements in the IC process.

Limitations: Prior studies have shown that electronic technology can enhance the IC experience by adapting to diverse learning styles, providing tiered information, and removing participants’ performance anxiety. However, the REDCap eIC survey didn’t provide all the necessary features
to engage different styles of learners, nor did we test adaptive technologies to accommodate participants with visual, auditory, and mobility challenges to render the eIC more inclusive.

Discussion: Informed Consent (IC) is an important means to ensure that research ethics principles are applied to research. eIC is a referrable experience for many participants. The rendition of an interactive eIC design in REDCap could be a beneficial solution for the virtual recruitment and consent process of most participants, including older adults and people traditionally underrepresented in research.

REDCap: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5764586/