Research on the protection of subjects'privacy in drug clinical trials from the perspective of responsible innovation
10.12026/j.issn.1001-8565.2025.08.03
- VernacularTitle:负责任创新视域下药物临床试验受试者隐私保护研究
- Author:
Yulu FAN
1
;
Xiaodan LI
;
Cuiying SHI
;
Yixin CHEN
Author Information
1. 上海健康医学院药学院,上海 201318
- Publication Type:Journal Article
- Keywords:
law and regulation;
clinical trial;
protection of subjects'privacy;
responsible innovation
- From:
Chinese Medical Ethics
2025;38(8):974-980
- CountryChina
- Language:Chinese
-
Abstract:
In drug clinical trials,the protection of subjects'privacy should take precedence over scientific exploration and societal benefits.This paper compared the differences in legal systems for the protection of subjects'privacy in China and abroad by employing methods such as literature review,case analysis,and comparison of domestic and foreign situations.It also elucidated the current ethical challenges faced by the protection of subjects'privacy,which primarily included imperfect laws and regulations,insufficient protection awareness among relevant personnel,risks of privacy breaches in critical links,and increased difficulty in data confidentiality under emerging technologies.From the perspective of responsible innovation,specific paths were proposed to protect subjects'privacy by using the four-dimensional structure of"prediction-reflection-negotiation-feedback,"maintaining a balance between ethical principles and technological innovation,ensuring the ethical and compliant nature of drug clinical trials,and thus better contributing to the cause of human health.
