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

Abstract

Introduction: The updated common rule, for human subjects research, requires that consents “begin with a ‘concise and focused’ presentation of the key information that will most likely help someone make a decision about whether to participate in a study” (Menikoff, Kaneshiro, Pritchard. The New England Journal of Medicine. 2017; 376(7): 613–615.). We utilized a community-engaged technology development approach to inform feature options within the REDCap software platform centered around collection and storage of electronic consent (eConsent) to address issues of transparency, clinical trial efficiency, and regulatory compliance for informed consent (Harris, et al. Journal of Biomedical Informatics 2009; 42(2): 377–381.). eConsent may also improve recruitment and retention in clinical research studies by addressing: (1) barriers for accessing rural populations by facilitating remote consent and (2) cultural and literacy barriers by including optional explanatory material (e.g., defining terms by hovering over them with the cursor) or the choice of displaying different videos/images based on participant’s race, ethnicity, or educational level (Phillippi, et al. Journal of Obstetric, Gynecologic, & Neonatal Nursing. 2018; 47(4): 529–534.). Methods: We developed and pilot tested our eConsent framework to provide a personalized consent experience whereby users are guided through a consent document that utilizes avatars, contextual glossary information supplements, and videos, to facilitate communication of information. Results: The eConsent framework includes a portfolio of eight features, reviewed by community stakeholders, and tested at two academic medical centers. Conclusions: Early adoption and utilization of this eConsent framework have demonstrated acceptability. Next steps will emphasize testing efficacy of features to improve participant engagement with the consent process.

Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting

“…E-consent allows researchers to present consent information that is enhanced with audio-visual or interactive features [ 8 ]. This could even extend to the use of videos or photographs so participants are able to “meet” the research team.…”

“…websites or tablets) and/or digital media (e.g. videos, audio) to enhance the presentation of information, and enable prospective research participants to give informed consent for recruitment [ 7 , 8 ]. A variety of e-consenting approaches can be used simultaneously, offering versatility to researchers who can customise them to suit their project’s needs.…”

“…There are a variety of custom-built platforms for entirely virtual consenting [ [11] , [12] , [13] , [14] ], as well as commercial software programs such as REDCap [ 8 ], ResearchKit [ 15 ] and Consent2Share [ 16 ]. E-consenting platforms have also been modified by researchers to enable participants to record their consenting preferences across multiple studies [ 17 , 18 ].…”

Research informatics and the COVID-19 pandemic: Challenges, innovations, lessons learned, and recommendations

“…We observed that the majority of CTSA organizations use Docusign As eConsent is conducted through individual secure login accounts, there may be insufficient tracking of virtual versus in-person consent and data capture to support robust comparisons. Vanderbilt's eConsent (REDCap eConsent framework) is the dominant source for a low-cost eConsent platform within the Consortium (11).…”

Development of a multi-component intervention to promote participation of Black and Latinx individuals in biomedical research

“…Details of the STRIDE eConsent component have been published elsewhere 26 . Briefly, we utilized the REDCap (Research Electronic Data Capture) platform 33 to create a web-based eConsent platform that includes tools that can be customized for a specific study.…”