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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OA

Analysis of the current situation for the regulation of life sciences and medical research involving hu-man subjects in a public hospital in Ningxia

中文摘要英文摘要

目的 分析宁夏某公立医院2020-2022 年开展的涉及人的生命科学和医学研究情况,对目前医院涉及人的生命科学和医学研究管理中存在的问题进行探讨,提出建议与改进措施.方法 利用该院2021-2022 年立项科研课题申请书、任务书、进展报告、结题报告及药物临床试验开展数据统计报表等资料,对涉及人的生命科学和医学研究进行统计和分析.结果 该院2020-2022 年涉及人的生命科学和医学研究科研立项数逐年增加,占总项目数之比超过50%,三年样本量超10 万人次,采集数量累计3 000 人以上的项目数呈现上升趋势,项目备案率低于10%.此类研究涉及大量人的生物样本和信息数据,具有研究价值,但科研人员缺乏备案意识,须引起医院的高度重视.结论 深度挖掘此类研究的医学价值是趋势,该院紧跟国家、自治区相关政策,开展动态监测和评估,提升监督管理能力是保护生物样本和信息数据的关键一环,同时也为其他公立医院开展相关监管工作提供参考.

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.

马斯波;哈琰;马慧敏;铁婷;魏景坤;张娜

宁夏回族自治区人民医院 宁夏银川 750002

公立医院涉及人的生命科学和医学研究监督管理

Public hospitalsLife sciences and medical research involving human subjectsSupervision and manage-ment

《现代医院》 2024 (007)

1007-1011,1014 / 6

宁夏回族自治区重点研发计划(软科学)项目(2022BSB03035)

10.3969/j.issn.1671-332X.2024.07.006

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