首页|临床研究数字化转型过程中电子知情同意应用的机遇与挑战

临床研究数字化转型过程中电子知情同意应用的机遇与挑战

扫码查看
随着科技的迅猛发展,我国临床研究正处于数字化转型的关键阶段,数字化技术为临床研究提供了更高效的方式.然而,作为保障研究参与者权益的核心环节,知情同意的数字化进程相对滞后,目前缺乏明确的法律法规和伦理框架来规范电子知情同意(eIC)的发展.本文通过回顾现有文献,分析eIC相较于传统纸质知情同意的优势,总结其现有的实践成果,并探讨在应用过程中面临的挑战,以期为eIC系统的构建提供概念框架和理论支持.
Opportunities and Challenges in the Application of Electronic Informed Consent During the Digital Transformation of Clinical Research
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.

clinical researchdigital transformationelectronic informed consentreal-world datadecentralized clinical trial

方文婧、姚晨、王斌、阎小妍

展开 >

北京大学第一医院医学统计室

北京大学临床研究所

海南省真实世界数据研究院

清华大学临床医学院

展开 >

临床研究 数字化转型 电子知情同意 真实世界数据 去中心化临床试验

2024

中国食品药品监管
中国医药报社

中国食品药品监管

影响因子:0.099
ISSN:1673-5390
年,卷(期):2024.(10)