医疗机构专病生物样本库建设与共享问题研究：来自25家市级医院的问卷调查

Survey on the Construction and Sharing Issue of Biobank in Medical Institutions: Data from 25 Municipal Hospitals

摘要:

目的：研究调查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，并提出相关意见建议。方法：对上海市有代表性的大型医疗机构生物样本库管理人员、专病生物样本存储人员展开问卷调查，了解医院相关样本库建设者的生物样本共享现状，在资源共享和样本库可持续发展中遇到的阻碍、问题及可行性建议等。结果：来自25家市级医疗机构的228名样本库建设者（包括临床医生、样本库管理人员/专业技术人员及行政管理者等）参与了问卷调查。有共享经历的48人（26.50%），无共享经历的133人（73.50%）。临床研究者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增长而增加（t=5.074，P＜0.001）。随着所建设的生物样本库建立年限的增加而增加（Χ2=31.176，P＜0.001）。为推动临床生物样本资源共享，必要性前5的条件是：医学伦理审查（94.30%），保障生物样本和数据资源的安全（94.30%），生物样本管理信息系统（87.72%），设定规范的共享流程（85.96%），知识产权保护和追究违约责任（85.09%）。结论：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。医疗机构应强化临床生物样本库的规划管理，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。

Abstract:

Objective: To survey staff of biobanks in public medical institutions in Shanghai on the current construction status of biobanks in medical institutions, as well as the bottleneck problems encountered in specimen resource sharing and feasible suggestions. Method: A questionnaire survey was conducted on biobanks in representative hospitals in Shanghai, to understand the current situation of biological sample sharing among hospital related sample bank builders, as well as the obstacles, problems, and feasible suggestions encountered in resource sharing and sustainable development of sample banks. Result: 228 sample bank builders from 25 municipal medical institutions participated in the questionnaire survey. 48 people (26.50%) had shared experiences, while 133 people (73.50%) had no shared experiences. The possibility of clinical researchers sharing increases with the increase of years of work experience in sample library construction related to clinical biological sample collection, research, and management (t=5.074, P<0.001). As the establishment period of the constructed biological sample library increases, it will increase（Χ2=31.176, P<0.001). To promote the sharing of clinical biological sample resources, the top 5 necessary conditions are: medical ethics review (94.30%), ensuring the security of biological samples and data resources (94.30%), biological sample management information system (87.72%), setting standardized sharing processes (85.96%), intellectual property protection and accountability for breach of contract (85.09%). Conclusion: Strengthening the construction of clinical biological sample banks is the top priority for medical institutions. To improve the utilization value of clinical specimen, the most important work is to strengthen the standardization construction of biobank in hospitals. Medical institutions should strengthen the planning and management of clinical biobank, take the disease-specific biobank as the goal, strengthen the standardized collection, storage and quality control of specimen, constantly improve the research data derived from specimen and unified management, and the sharing needs to fully consider the fairness of the cooperation of stakeholders and the protection of rights and interests.