Comparative Effectiveness Of eConsent: Systematic Review

By Bill Byrom, Ph.D., VP Product Intelligence and Positioning

Signant collaborated with AstraZeneca, Oxford PharmaGenesis, and Nottingham Trent University to contribute scientifically to a systematic review comparing electronic and pen-and-paper consenting. The review investigated electronic informed consent (eConsent) versus paper informed consent forms (ICF) regarding patient comprehension and acceptability, enrollment and retention rates, time to complete consent, and site workload. Notably, eConsent demonstrated improved comprehension, crucial for patient retention in trials.

Studies using comprehensive comprehension measurement methods favored eConsent over paper ICFs, aligning with psychological frameworks supporting deeper processing and multimedia learning. Additionally, eConsent garnered higher patient satisfaction across studies, despite slightly longer completion times, attributed to increased engagement. These findings support the perceived benefits of eConsent, including clarity, compliance, and simplification of consent processes, highlighting its potential to enhance clinical trial practices. Detailed results are available in the Journal of Medical Internet Research paper.