China's clinical research is undergoing a crucial phase of digital transformation driven by rapid advancements in science and technology.Digital technology offers a more efficient approach to conducting clinical research.Nevertheless,the digitization of informed consent,a crucial component in protecting participant rights,has lagged behind.Currently,there is a shortage of clear legal regulations and ethical frameworks governing the advancement of electronic informed consent(eIC).By reviewing existing literature,this paper examines the benefits of eIC compared to traditional paper-based informed consent,summarizes its current practical accomplishments,and investigates the challenges faced during its implementation.This study aims to establish a conceptual framework and theoretical basis for the future development of an eIC system.
维普
万方数据