Research on common issues and solutions in scientific and ethical review of investigator-initiated trials:based on the practice of a certain hospital
10.12026/j.issn.1001-8565.2025.08.06
- VernacularTitle: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
- Author:
Lihan XING
1
;
Shuilong GUO
1
;
Xu ZUO
1
;
Yue LI
1
;
Yingshuo HUANG
1
Author Information
1. 首都医科大学附属北京友谊医院科技处,北京 100050
- Publication Type:Journal Article
- Keywords:
scientific review;
ethical review;
investigator-initiated trial;
collaborative review mechanism
- From:
Chinese Medical Ethics
2025;38(8):996-1002
- CountryChina
- Language:Chinese
-
Abstract:
The number of investigator-initiated trials(IIT)projects in medical institutions has increased rapidly,yet there are certain issues such as uneven quality and insufficient consideration of research design.The scientific review and ethical review of IIT complement each other.To improve the research quality and review efficiency of IIT and reduce review repeatability,this paper described the current situation of scientific review and ethical review of IIT in a tertiary A hospital.Combined with literature analysis,the common 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 ability and awareness of relevant personnel.The explored solutions included establishing a collaborative review mechanism,by unifying the key points of collaborative review,clarifying the review responsibilities of each committee,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 efficiency of review,and promote the high-quality and healthy development of IIT.
