医疗机构专病生物样本库建设现状与共享问题:基于25家上海市市级医院的问卷调查结果  

Current Status and Sharing Issues of Disease-Specific Biobanks in Medical Institutions:Findings from a Survey of 25 Municipal Hospitals in Shanghai

作　　者：舒之群 沈慧青[1,2] 汪雪玲 陈玥尧[1,2] 吴皓 许锋[1,2] Shu Zhiqun;Shen Huiqing;Wang Xueling;Chen Yueyao;Wu Hao;Xu Feng(Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200011,China;Center for Specialty Strategy Research of Shanghai Jiao Tong University China Hospital Development Institute,Shanghai 200011,China)

机构地区：[1]上海交通大学医学院附属第九人民医院,上海200011 [2]上海交通大学医院发展研究院学科建设研究所,上海200011

出　　处：《科技管理研究》2025年第5期236-242,共7页Science and Technology Management Research

基　　金：上海市科学技术委员会“科技创新行动计划”软科学研究项目“公立医院高质量发展背景下医疗机构专病生物样本库共享模式研究”(23692115400);上海市卫生健康委员会卫生健康政策研究课题(定向委托)“基于国际医学前沿发展趋势的上海临床科研发展思路研究”(2024HP79)。

摘　　要：生物样本资源的应用共享对促进生物样本库可持续发展和最大化发挥科研价值具有重大意义。以上海市公立医疗机构专病生物样本库为研究对象,对来自25家上海市市级医院的228名人员开展问卷调查,询问其关于临床生物样本资源共享的态度和观点,以探究医疗机构生物样本库的建设现状,以及在资源共享和样本库可持续发展中遇到的瓶颈问题,并据此提出相关意见建议。研究结果显示,在181位来自临床科室的样本库建设者中,有生物样本共享经历的仅为48人,且临床研究者进行生物样本共享的可能性随着从事临床生物样本采集、研究、管理等相关样本库建设的工作年限,以及生物样本库建立年限的增加而提高。为推动临床生物样本资源共享,必要性居前五的条件依次是:医学伦理审查,保障生物样本和数据资源的安全,生物样本管理信息系统,设定规范的共享流程,知识产权保护和追究违约责任。为提高疾病样本的利用价值,各医疗机构最首要的工作重点是加强临床生物样本库的标准化建设,应以专病生物样本全息库为目标,加强样本的标准化采集、存储和质量控制,统一并不断完善对生物样本衍生研究数据的管理,共享过程充分考虑利益相关方合作的公平性和权益保障。The sharing and application of clinical specimen resources are of great significance to promoting the sustainable development of biobanks and maximizing their scientific research value.This study focuses on the current status and sharing issues of disease-specialized biobanks in public medical institutions in Shanghai.A questionnaire survey was conducted among 228 personnel from 25 municipal hospitals in Shanghai to explore their attitudes and perspectives on clinical biological sample resource sharing.The aim was to investigate the current state of biobank development in medical institutions,identify bottlenecks in resource sharing and sustainable development,and propose relevant recommendations.The results indicate that among 181 biobank builders from clinical departments,only 48 had prior experience in biological sample sharing.Moreover,the likelihood of clinical researchers engaging in sample sharing increased with their years of experience in clinical sample collection,research,and management,as well as with the duration of the biobank's establishment.The five most critical conditions for promoting clinical biological sample resource sharing were identified as follows:medical ethics review,ensuring the security of biological samples and data resources,biobank management information systems,standardized sharing procedures,and intellectual property protection with mechanisms for breach accountability.To enhance the utilization value of disease samples,the primary focus of medical institutions should be on strengthening the standardization of clinical biobank development.This should be guided by the goal of establishing a comprehensive specialized disease biobank,emphasizing standardized sample collection,storage,and quality control.Additionally,the management of research data derived from biological samples should be unified and continuously improved.The sharing process should fully consider the fairness of collaboration and the protection of stakeholders'rights and interests.

关 键 词：生物样本库 医疗机构 共享机制 生物样本共享 样本库建设 

分 类 号：G311[文化科学] G301