小規模体制で大規模な遠隔同意取得に挑む—浜松医科大学医学部附属病院におけるeConsent導入実践報告—

抄録

Electronic consent (eConsent) has garnered increasing global attention as a crucial method for facilitating decentralized clinical trials (DCTs). However, its adoption remains limited in studies in small-scale institutions or those with personnel and budgetary constraints. In a prospective observational study aimed at improving the diagnostic accuracy in differentiating bipolar disorder from depression, we introduced eConsent and successfully obtained over 500 completed remote informed consent forms within a small-scale operational framework. This paper reports on the practical implementation of this approach. The study was coordinated by a three-member team consisting of a principal investigator, a departmental clerk, and a project manager. A dedicated website was developed to recruit participants, and explanatory materials such as a written document and a 12-minute video were provided. Informed consent was obtained using a cloud-based platform, and participant identity was verified remotely via Zoom. Pre-prepared email templates were used to streamline communication with participants.

Of the 646 individuals who expressed interest in participating, 505 ultimately provided informed consent. The use of standardized email templates facilitated efficient and consistent handling of over 80% of correspondence. Although 16% of consent forms contained input errors, these were resolved with prompt email follow-up. The combined use of digital tools and explanatory videos enhanced participant comprehension and reduced administrative burden on the study team.

This study indicates that large-scale remote informed consent can be achieved even within a small-scale operational framework and offers a practical model for future eConsent implementation in decentralized clinical trials, particularly in resource-limited research environments.