研究用電子化知情同意法規演進與國際指引

Regulatory Evolution and International Guidelines of Electronic Informed Consent in Research

隨著醫療數位化與遠距服務快速發展，電子化知情同意（electronic informed consent，e-consent）逐漸成為取得研究參與者知情同意的替代選擇，採取e-consent不僅是技術問題，也攸關研究品質、資料安全及研究參與者的權益保障。本文首先回顧台灣關於電子化知情同意，於臨床及研究場域的規範發展歷程，接著簡介美國、歐盟、英國、日本及新加坡關於e-consent的規範指引，並與台灣現行指引進行比較。期能為未來相關政策制定、醫療機構實務推動與倫理審查提供具體參考，促進數位醫療治理與病人自主之協調發展。

With the rapid advancement of healthcare digitalization and remote services, electronic informed consent (e-consent) has increasingly emerged as an alternative approach for obtaining informed consent from research participants. The implementation of e-consent involves not only technical considerations but also issues related to research quality, data security, and the protection of participants’rights and interests. This article first reviews the development of regulations governing e-consent in clinical and research settings in Taiwan. It then provides an overview of regulatory frameworks and guidance on e-consent in the United States, the European Union, the United Kingdom, Japan, and Singapore, and compares these with Taiwan’s current guidelines. The aim is to offer practical references for future policy development, implementation in healthcare institutions, and ethical review processes, thereby promoting the coordinated advancement of digital health governance and patient autonomy.