電子的手法によるインフォームド・コンセントを受ける手続きに関する実態調査:臨床研究コーディネーター等を対象とした Web アンケート調査

Translated title of the contribution: Current Status of Electronic Informed Consent: Results of Web-based Survey Targeting Clinical Research Coordinators

Mari Terada, Yayoi Sato, Tomoko Osawa, Yoshihiko Iijima, Miho Goto, Akemi Tamaura

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Translated title of the contributionCurrent Status of Electronic Informed Consent: Results of Web-based Survey Targeting Clinical Research Coordinators
Original languageJapanese
Pages (from-to)19-28
Number of pages10
JournalJapanese Journal of Clinical Pharmacology and Therapeutics
Volume54
Issue number1
DOIs
Publication statusPublished - 2023

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

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