研究者发起的临床研究科学性与伦理审查共性问题及解决方案研究

——基于某医院的实践

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[中图分类号]R-052 [文献标志码]A [文章编号]1001-8565（2025）08-0996-07

DOI：10.12026/j.issn.1001-8565.2025.08.06

Research on common issues and solutions in scientific and ethical review of investigator-initiated trials ：

basedonthepracticeofacertainhospital XINGLihan，GUO Shuilong，ZUO Xu， LI Yue，HUANG Yingshuo （Department of Science and Technology，Beijing Friendship Hospital， Capital Medical University，Beijing 100050，China）

Abstract：The numberof investigator-initiated trials（IIT） projects inmedical institutions has increased rapidly，yetthere are certain issues such as uneven qualityand insuficient consideration ofresearch design.The scientific review and ethical review of IIT complement each other.To improve the research quality and review eficiencyof IITand reduce review repeatability，this paper described the current situation of scientific review andethical review of IIT ina tertiary A hospital. Combined with literature analysis，thecommon issues in scientific review and ethical review were summarized into four types： standardization，reliability，safety，and lag.Corresponding to these common issues，the reasons for their occurrence were analyzed as the lack of unified review points，the ambiguity of each review focus，the lack of review communication and exchange，and the lack of abilityand awareness of relevant personnel.The explored solutions included establishing a collaborative review mechanism，by unifying the key points of collborative review，clarifying the review responsibilities of each commitee，building a review communication mechanism with the help of information technology， strengthening training and publicity，and other means. These solutions aimed to promote the organic combination of scientific review and ethical review，fully leverage the synergistic effect，improve the effciency of review，and promote the high-quality and healthy development of IIT.

Keywords： scientific review；ethical review; investigator-initiated trial; colaborative review mechanism

为更好地发挥医学原始创新能力，医疗机构内由研究者发起的临床研究（investigator-initiatedtrial，IIT）项目数量迅速增长。（剩余11214字）