Protection of Informed Consent Rights for Subjects in Drug Clinical Trials
10.12026/j.issn.1001-8565.2023.08.03
- VernacularTitle:药物临床试验研究参与者知情同意权的保护
- Author:
Yuxin WANG
1
;
Shaoqing MA
1
Author Information
1. School of Humanities, Beijing University of Chinese Medicine, Beijing 102488, China
- Publication Type:Journal Article
- Keywords:
Drug Clinical Trials;
Trial Subjects;
Informed Consent Right;
Ethical Review
- From:
Chinese Medical Ethics
2023;36(8):840-846
- CountryChina
- Language:Chinese
-
Abstract:
The right to informed consent is the basic right of subjects in drug clinical trials. International treaties and domestic laws have successively formed a basic right protection framework, while there are still some problems such as imperfect legal norms and incomplete practical operations. To meet future challenges, it is necessary to further improve legislation, standardize notification procedures, improve notification content, expand dynamic notification methods, and strengthen ethical review, so as to build a standardized and modern system for protecting the right to informed consent of subjects.
