Exploration of legal regulations of investigator-initiated trials
10.12026/j.issn.1001-8565.2025.10.11
- VernacularTitle:研究者发起的临床研究法律规制探讨
- Author:
Hongjing WANG
1
;
Shuhui SUN
1
;
Yumei XU
2
;
Jiyin ZHOU
3
Author Information
1. School of Management， Shandong Second Medical University， Weifang 261053， China
2. School of Marxism， Shandong Second Medical University， Weifang 261053， China
3. Clinical Research Center， the Second Affiliated Hospital of Army Medical University， Chongqing 400037， China
- Publication Type:Journal Article
- Keywords:
investigator-initiated trial;
legal supervision;
legal regulation
- From:
Chinese Medical Ethics
2025;38(10):1306-1314
- CountryChina
- Language:Chinese
-
Abstract:
The investigator-initiated trials （IIT）， as a widely existing form of clinical research both domestically and internationally， have attracted the attention of governments around the world due to the potential legal risks and issues they may cause， and the trend of legal supervision has gradually strengthened. The legal regulation of IIT in China is still in its early stages， with numerous legal issues that need to be clarified and sorted out. Based on the domestic and international legal reviews of IIT， this paper systematically sorted out the current situation of legal supervision of IIT in China and examined the existing issues， including weak legislative rules， incomplete regulatory systems， imperfect protection rules for research participants and informed consent systems， inadequate regulation of conflicts of interest management， and lax legal supervision of ethical review. Furthermore， this paper proposed suggestions for legal regulation of IIT from three perspectives， including strengthening legislation and emphasizing regulation， improving the mechanism for protecting research participants’ rights and interests， and balancing the legalization of IIT and the scientific development of clinical research， with a view to providing references for legal regulatory paths of IIT in China.
