Supervision of Electronic Informed Consent in International Clinical Research and Its Implications for China
10.12026/j.issn.1001-8565.2023.03.05
- VernacularTitle:国际临床研究电子知情同意监管及对中国的启示
- Author:
Xiaoran LU
1
;
Xiaomin WANG
2
;
Xin TAN
1
;
Xing LIU
3
Author Information
1. School of Literature and Journalism, Central South University, Changsha 410075, China
2. Clinical Pharmacology Center/Clinical Trial Research Center, the Third Xiangya Hospital of Central South University, Changsha 410013, China; Research Center for Medical Ethics, Central South University, Changsha 410013, China
3. Medical Ethics Committee, Xiangya Hospital of Central South University, Changsha 410008, China; Medical Humanities Research Center/Hospital Administration Institute, Central South University, Changsha 410008, China
- Publication Type:Journal Article
- Keywords:
Clinical Research;
Electronic Informed Consent;
Ethics Committee;
Subject Privacy Protection
- From:
Chinese Medical Ethics
2023;36(3):263-270
- CountryChina
- Language:Chinese
-
Abstract:
At present, China is still in the exploratory stage in the field of electronic informed consent (eIC), and relevant policies, regulations and application guidelines have not yet been established and improved. While the traditional informed consent supervision system is difficult to meet the needs of the innovative development of eIC, such as subject privacy and data security. Through sorting out and analyzing the legal norms and construction system of eIC supervision in Europe and the United States, combined with the current development status, problems, and challenges of eIC in China, this paper targeted proposed the path to construct the supervision of eIC in clinical research in China from the aspects of restricting the signing form and process of eIC, adjusting the ethical review paradigm of eIC, enhancing the strength of eIC ethical review, improving the construction of eIC legal system, and strengthening the training of relevant researchers.
