Implementing Electronic Informed Consent in a Resource-Limited Setting: A Case Study from Hamamatsu University Hospital

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.