Bridging the Gap: A Systematic Review of Digital Consent Tools to Enhance Participation and Procedures in...

Informed consent is central to ethical clinical research, yet traditional paper-based processes are often lengthy, complex, and literacy-dependent, disproportionately disadvantaging participants in low-resource settings. This review assessed the role of digital consent tools (e-consent) in enhancing comprehension, satisfaction, and documentation quality in low-resource settings, while also examining barriers, facilitators, and scalability. Given the small number of studies identified, findings should be interpreted as preliminary. Following Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines, PubMed, Embase, Scopus, and Cochrane were searched up to August 2025 for randomized and non-randomized trials, observational studies, pilot projects, and systematic or scoping reviews comparing e-consent with traditional methods. Risk of bias was assessed using ROBINS-I for non-randomized studies, AMSTAR-2 for systematic reviews, and the JBI tool for scoping reviews, with findings synthesized narratively. Ultimately, only six studies met the inclusion criteria, underscoring the limited evidence base in this area. Multimedia, offline tablet-based, web-based, and AI-assisted e-consent platforms consistently improved comprehension and satisfaction, while documentation errors decreased markedly in low-resource contexts. Effects on enrollment were mixed, with outcomes influenced by trial protocols and platform usability. Reported barriers included low digital literacy, connectivity challenges, and heterogeneity of tools, whereas facilitators included multilingual adaptability, offline compatibility, and integration into clinical workflows. Overall, e-consent demonstrates strong potential to reduce inequities in the consent process, provided systems are adapted to local cultural, literacy, and infrastructural contexts and aligned with international regulatory standards.