New requirements and countermeasures for scientific review of investigator-initiated trial
10.3969/j.issn.1671-332X.2025.03.034
- VernacularTitle:研究者发起的临床研究科学性审查的新要求及应对建议
- Author:
Yue SUN
1
;
Jiyin ZHOU
Author Information
1. 四川锦欣西囡妇女儿童医院 四川成都 610066
- Publication Type:Journal Article
- Keywords:
Investigator-initiated trial;
Scientific review;
Ethics review
- From:
Modern Hospital
2025;25(3):467-471
- CountryChina
- Language:Chinese
-
Abstract:
Objective To implement the new requirements of the scientific review of investigator-initiated trail in Admin-istrative Measures for Investigator-initiated Trial in Medical and Health Institutions,and to consider its implementation measures.Methods This paper summarized the current status of scientific review of investigator-initiated trial in China,analyzed the new requirements of scientific review in Administrative Measures for Investigator-initiated Trial in Medical and Health Institutions,and put forward suggestions for standardizing and efficiently implementing scientific review.Results The analysis found that the sci-entific review of investigator-initiated trial in China has the following status:most provinces and cities are still in the stage of ex-ploring and implementing scientific review,there is no scientific review system,rules and procedures at the national level,the scientific review system,rules and procedures of the provinces and cities that have been tried out still need to be improved,most medical and health institutions and their superior regulatory agencies are still in the initial stage of review and supervision,and the scientific review awareness of investigators and their corresponding education and training are lacking.Administrative Meas-ures for Investigator-initiated Trial in Medical and Health Institutions put forward new requirements for scientific review,including medical and health institutions should formulate scientific review systems,rules and procedures to implement scientific review,and only need to carry out scientific review for observational research and interventional research that exceed the minimum risk,and need to strengthen the follow-up management of scientific review.Conclusion In order to standardize and efficiently imple-ment scientific review,the recommended measures include designation of the organization and the management department respon-sible for scientific review by medical and health institutions,the provision of human,financial and material support by medical and health institutions,the formulation of scientific review work systems and standard operating procedures that comply with laws and regulations and can be effectively operated,the implementation of scientific review according to the risk level,the close link-age of scientific review with project application and ethics review to reduce the burden on investigators,and the procedures and research methodology of scientific review for medical and health institutions to be trained in a dragnet manner,counseling services are provided to investigators when necessary.
