摘要
目的通过对医疗机构干细胞临床研究学术委员会的调查分析,结合同济大学附属东方医院干细胞临床研究学术委员会建设实践与探索,探讨加强干细胞临床研究学术委员会建设的策略。方法设计干细胞临床研究学术委员会运行情况调查问卷,并对国家备案医疗机构的干细胞临床研究学术委员会人员组成、运作模式、相关资质等进行调查和分析。2022年8月—9月,通过邮箱和微信发放问卷102份。最终,小程序回收问卷49份。采用WPS Office双录入问卷数据,并进行逻辑检错,应用SPSS 20.0软件进行统计分析,去除不完整问卷、同机构重复问卷、非国家备案机构问卷,收到国家备案医疗机构有效问卷21份。结果经对调查表分析显示,医疗机构干细胞临床研究学术委员会建设中存在未独立设置相关机构、人数不合理、未包含机构外专家、人员与伦理委员重叠等组成不合理,审查材料要求标准、放行检验标准不统一等问题。结论针对以上问题建议从“三性”(独立性、学术性、规范性)、“三理”(委员数量合理、委员专业合理、委员组成合理)、“三重”(重视立项流程、重视审查要点、重视放行检验)3个角度加强干细胞学术委员会建设。
Objective To discuss strategies to strengthen the construction of stem cell clinical research academic committees through an investigation and analysis of stem cell clinical research academic committees in medical institutions,combined with the practical experience and exploration of the academic committee of stem cell clinical research in Shanghai East Hospital,Tongji University School of Medicine.Methods A questionnaire on the operation of stem cell clinical research academic committees was designed,and surveys and analyses were conducted on the composition of personnel,operation modes,and relevant qualifications of stem cell clinical research academic committees in nationally registered medical institutions.From August to September 2022,102 questionnaires were distributed through email and WeChat.49 questionnaires were collected through a mini-program.The data from the questionnaires were double-entered using WPS Office and subjected to logic checks.Statistical analysis was performed using SPSS 20.0 software.Incomplete questionnaires,duplicate questionnaires from the same institution,and questionnaires from non-nationally registered institutions were excluded.21 valid questionnaires from nationally registered medical institutions were received.Results The analysis of the survey forms revealed several issues in the construction of stem cell clinical research academic committees in medical institutions,including the lack of independent organizational structures,unreasonable personnel numbers,the absence of external experts,and overlaps with ethics committees in the composition of members.There were also inconsistencies in the requirements for review materials and release testing standards.Conclusion In response to the above issues,it is recommended to strengthen the construction of stem cell academic committees from three perspectives."Three characteristics"(independence,academic and normative),"three rationales"(reasonable number of members,reasonable major of members,and reasonable composition of members),and"
作者
何斌
李佳潞
赵庆辉
刘中民
汤红明
HE Bin;LI Jialu;ZHAO Qinghui;LIU Zhongmin;TANG Hongming(Translational Medical Center for Stem Cell Therapy&Institute for Regenerative Medicine,Shanghai East Hospital,Tongji University School of Medicine,National Stem Cell Translational Resource Center,Shanghai Institute of Stem Cell Research and Clinical Translation,Shanghai Engineering Research Center for Stem Cell Clinical Treatment,Shanghai 200123,China)
出处
《中国研究型医院》
2023年第5期25-30,共6页
Chinese Research Hospitals
基金
上海高校Ⅳ类高峰学科
上海市卫健委专项课题干细胞临床研究质量控制体系的研究与建立(202150023)
上海市卫健委专项课题重大疾病的干细胞治疗研发与临床转化体系建立(2019CXJQ01)。
关键词
干细胞
治疗
临床研究性
伦理学委员会
学术委员会
Stem cell
Therapies
Investigational
Ethics committees
Construction of academic committees
