Abstract
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.). 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. The eConsent framework includes a portfolio of eight features, reviewed by community stakeholders, and tested at two academic medical centers. 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.
Highlights
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”
The Food and Drug Administration (FDA) has released guidance to address these considerations with recommendations for Institutional Review Boards (IRBs), investigators and sponsors on the use of eConsent and the processes associated with obtaining informed consent for clinical investigations using various forms of digital electronic data [10]
Studio attendees emphasized the importance of representing minority populations and encouraged creating vignettes by depicting supportive and helpful interactions with medical staff and expressed a preference for use of animation to depict invasive procedures
Summary
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” The enhanced features within eConsent provide an opportunity to facilitate recruitment and retention of participants with particular opportunities to engage underrepresented minority groups through improving understanding and the consenting experience [9]. Another driver for eConsent is the movement toward more pragmatic trials that either (1) engage directly with patients using centralized resources for consenting or (2) utilize research sites that do not typically conduct clinical trials and where paper informed consent presents a barrier to participation.
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