多中心临床研究伦理审查结果互认实施中的问题与建议OA

Objective:To investigate the current situation of mutual recognition for ethical review outcomes in multicenter clinical research across 10 contracting medical institutions in Guangdong Province,analyze existing issues and propose improvement recommendations,thereby promoting the standardized management of mutual recognition for ethical review outcomes in medical institutions.Methods:Data from 381 multicenter clinical studies conducted in these 10 medical institutions from January 24 to October 31,2024,were collected.Text visualization was performed using Python and the WordCloud library,and statistical analyses were conducted with SPSS 25.0.Results:Of the 381 studies investigated,industry-sponsored clinical trials(ISTs)accounted for 51.71%,while investigator-initiated clinical trials(IITs)constituted 48.29%.The proportions of ethical committees serving as primary reviewers and collaborative reviewers were 33.33%and 66.67%,respectively.The confirmation methods of mutual recognition outcomes were primarily expedited reviews(50.66%)and meeting reviews(49.34%),and no cases of"direct confirmation"were found.The Chi-square test revealed statistically significant differences in review confirmation methods based on project type(x2=14.851,P<0.001)and ethics committee role(x2=69.435,P<0.001).The frequency distribution trend of the contingency table showed that IST projects and primary ethics committees preferred to employ meeting review(58.88%and 79.53%respectively,both higher than the average level of 49.34%),while IIT projects and the collaborative ethics committees more frequently utilized expedited review(60.87%and 65.75%respectively,both higher than the average level of 50.66%).Conclusion:The confirmation methods of mutual recognition for ethical review outcomes in multicenter clinical research are significantly associated with the role of the ethics committee and the type of project.It is recommended to improve management systems,enhance information construction and personnel training,as well as clarify mutual recognition responsibilities and strengthen supervision.This aims to ensure review quality while improving mutual recognition efficiency,thereby safeguarding the rights and interests of research participants.