2023 Volume 54 Issue 1 Pages 19-28
Clinical trials have become increasingly electronic and digitalized, and electronic informed consent has begun to gain importance. In order to picture the current situation of eConsent in Japanese medical institutions, we asked research assistants, including CRCs, to answer a questionnaire survey. Responses were obtained from 1403 persons. The experience with eConsent was low; 128（9.1％）had used in informing process and 71（5.1％）in consent process. Of those with eConsent experience, 94（73.4％）had experience in in-person only study and 13（10.9％）in remote only study. In cases where eConsent was considered but abandoned, respondents reported that medical institution did not have sufficient SOP, tablet devices, and/or internet network. Many also expressed concern about the ability of elderly patients to use electronic methods. The importance of eConsent is expected to increase, as clinical trials are anticipated to become diverse, including those requiring remote access, non-contact manner, or virtual conduction. Accordingly, we should consider an appropriate eConsent that is beneficial to all the stakeholders ‒ the sponsor, medical institution, and the subject ‒ and it should become a natural option in the future, in situations where eConsent is necessary.
