利用论文管理平台推动研究者规范进行伦理审查的实践与思考  

Practice and reflection on promoting researchers to conduct ethical review in a standardized manner usinga paper management platform

作　　者：高明[1] 欧阳明[1] 许卫卫[2] Gao Ming;Ouyang Ming;Xu Weiwei(Guangzhou First People′s Hospital,Guangzhou 510180,Guangdong Province,China;Peking University Shenzhen Hospital,Shenzhen 518036,Guangdong Province,China)

机构地区：[1]广州市第一人民医院,广州510180 [2]北京大学深圳医院,深圳518036

出　　处：《中华医学科研管理杂志》2024年第4期284-289,共6页Chinese Journal of Medical Science Research Management

基　　金：广东省医学科学技术研究基金(B2023372)。

摘　　要：目的当前科学研究已进入了一个全新阶段,科技进步带来了一系列的新型伦理问题,如何提升临床研究研究者规范进行伦理审查值得关注。本研究在总结研究者规范进行伦理审查所面临的挑战后,介绍了A院利用论文管理平台促进研究者规范进行伦理审查的实践,提出相关思考。方法第一阶段,经过伦理委员会和科研管理部门协商,梳理出研究者在临床研究过程中的关键管理节点,结合论文管理规定,以论文管理为抓手,倒逼研究者规范研究行为。第二阶段,多部门协作,伦理委员会协调各部门之间的沟通和合作,确保临床研究的规范化。结果经过3年多的实践,因缺少伦理审查批件被驳回的论文占比降低,被驳回的回顾性研究和干预性研究论文数整体呈下降趋势,护理和技师/药师群体需要重点关注。结论政府健全监管机制,完善考核评价体系;期刊要发挥伦理审查"关口"作用;医院加强多部门协同,不断优化流程持续宣传;研究者自觉提升伦理意识。ObjectiveWith the advancement of science and technology,there are a series of new ethical issues in scientific research.How to improve the standardization of ethical review for clinical researchers deserves attention.This study summarized the challenges faced by researchers in conducting ethical reviews in a standardized manner,introduced the practice of A hospital in promoting researchers to conduct ethical reviews in a standardized manner using a paper management platform,and put forward related thoughts.MethodsIn the first stage,after negotiation between the Ethics Committee and the scientific research management department,the key management nodes of researchers in the process of clinical research were sorted out.Combined with the regulations on paper management,the standardization of research behavior was forced by taking paper management as the starting point.In the second stage,a multiple-department collaboration was carried out in which the Ethics Committee coordinated communication and cooperation among various departments to ensure the standardization of clinical research.ResultsAfter more than 3 years of practice,the proportion of papers rejected due to lack of ethical review approval decreased,and the number of retrospective and interventional research papers rejected showed a downward trend overall.Nursing and technician/pharmacist groups need to be paid special attention to.ConclusionsThe government should improve the supervision mechanism and perfect the evaluation system;journals should play a role in″passing″ethical review;hospitals should strengthen multi-department collaboration and continuously optimize processes and publicity;researchers should consciously enhance their ethical awareness.

关 键 词：论文管理 伦理审查 科研管理 伦理意识 部门合作 规范 

分 类 号：R19[医药卫生—卫生事业管理]