现代医院2024，Vol.24Issue(7)：1007-1011,1014,6.DOI:10.3969/j.issn.1671-332X.2024.07.006
宁夏某公立医院涉及人的生命科学和医学研究监管现状分析
Analysis of the current situation for the regulation of life sciences and medical research involving hu-man subjects in a public hospital in Ningxia
摘要
Abstract
Objective To analyze the situation of life sciences and medical research involving human subjects conducted in a public hospital in Ningxia from 2020 to 2022 and explore the problems in the current management of such research and pro-vides suggestions for improvement.Methods Data were collected from research project application documents,task assign-ments,progress reports,final reports,and statistical tables of clinical drug trials conducted in the hospital from 2021 to 2022.Statistical analysis was performed on the life sciences and medical research involving human subjects.Results The number of research projects involving human subjects in the hospital increased annually from 2020 to 2022,accounting for more than 50%of the total projects.Over the three years,the sample size exceeded 100,000,and the number of projects with a cumulative collec-tion of more than 3,000 individuals showed an upward trend.However,the project registration rate was less than 10%.These types of research involve a large number of biological samples and information data,which have research value.However,re-searchers lack awareness of project registration,highlighting the need for greater attention from the hospital.Conclusion It is a trend to explore the medical value of this type of research in depth.The hospital should closely follow relevant national and re-gional policies,conduct dynamic monitoring and evaluation,and enhance supervision and management capabilities as a key factor in protecting biological samples and information data.This study also provides reference for other public hospitals in carrying out related regulatory work.关键词
公立医院/涉及人的生命科学和医学研究/监督管理Key words
Public hospitals/Life sciences and medical research involving human subjects/Supervision and manage-ment分类
医药卫生引用本文复制引用
马斯波,哈琰,马慧敏,铁婷,魏景坤,张娜..宁夏某公立医院涉及人的生命科学和医学研究监管现状分析[J].现代医院,2024,24(7):1007-1011,1014,6.基金项目
宁夏回族自治区重点研发计划(软科学)项目(2022BSB03035) （软科学）
