研究者发起的临床研究法律规制探讨

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[中图分类号]R-052 [文献标志码]A [文章编号]1001-8565（2025）10-1306-09

DOI：10.12026/j. issn.1001-8565.2025.10.11

Explorationoflegalregulationsofinvestigator-initiatedtrials

WANGHongjing1，SUNShuhui1，XU Yumei²，ZHOU Jiyin

（1.SchoolofManagement，Shandong SecondMedical University，Weifang 26lO53，China;2.Schoolof Marxism，Shandong SecondMedical University，Weifang 26lO53，China;3. Clinical Research Center，the Second Affiliated Hospital of Army Medical University， Chongqing 4Ooo37，China）

Abstract：The investigator-initiated trials（IIT），as a widely existing form of clinical research both domestically and internationally，haveattracted theattention of governments around the world due to the potential legal risks and isues 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 IITand the scientific development ofclinical research，with aview to providing references for legal regulatory paths of IIT in China.

Keywords： investigator-initiated trial; legal supervision;legal regulation

1IIT的法律审视

研究者发起的临床研究（investigatorinitiatedtrials，IIT），也称为非注册类临床研究。（剩余14290字）