负责任创新视域下药物临床试验受试者隐私保护研究

[中图分类号]R-052 [文献标志码]A [文章编号]1001-8565（2025）08-0974-07

DOI：10.12026/j. issn.1001-8565.2025.08.03

Researchon theprotectionof subjects’privacyindrugclinicaltrials from theperspectiveofresponsibleinnovation

FANYulu1，LIXiaodan²，SHICuiying，CHENYixin1

College of Pharmacy，Shanghai University ofMedicine & Health Sciences， Shanghai 2Ol318，China; 2. School ofPharmacy， Zhangzhou Health Vocational College， Zhangzhou 363Ooo，China）

Abstract： In drug clinical trials，the protection of subjects’privacy should take precedence over scientific exploration and societal benefits.This paper compared the diferences 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 currnt ethical challenges faced by the protection of subjects’privacy，which primarily included imperfect laws and regulations，insuficient protection awareness among relevant personnel，risks of privacy breaches in critical links，and increased dificulty 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-reflectionnegotiation-feedback，”maintaining a balance between ethical principles and technological inovation，ensuring the ethical and compliant nature of drug clinical trials，and thus better contributing to thecause of human health.

Keywords： law and regulation; clinical trial;protection of subjects’privacy;responsible innovation

0 引言

药物研发是一项极具专业性、系统性、复杂性和周期性的任务，不仅仅涉及科学技术创新，更关乎人类健康及生命安全。（剩余11170字）