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作 者:于兰亦 朝呼和 王敏 贺晓慧 Yu Lanyi;Chao Huhe;Wang Min;He Xiaohui(Development Center for Medical Science and Technology,National Health Commission,Beijing 100044,China)
机构地区:[1]国家卫生健康委医药卫生科技发展研究中心,北京100044
出 处:《中华医学科研管理杂志》2023年第2期81-85,共5页Chinese Journal of Medical Science Research Management
摘 要:目的分析现阶段中央财政资金支持的科技计划项目伦理监管现状和问题,提出完善项目管理的对策建议。方法结合"十三五"期间某重点专项立项项目实践管理经验,研究指南编制、评审立项、过程管理、结题验收等各阶段伦理监管问题,根据项目研究特点和涉及伦理风险的程度提出4类分级审查的建议。结果较低风险项目仍由项目承担单位伦理委员会审查,此类项目主要由项目单位承担伦理监管责任并跟踪审查。敏感类项目和较高伦理风险项目除由项目单位伦理委员会进行审查外,项目管理专业机构应加强伦理监管,在不同节点采取风险控制措施。具有较大伦理争议的项目和高风险项目建议由国家科技伦理委员会进行审查,并构建重大科技伦理问题公众参与讨论机制。建议针对前沿新技术、新领域开展前瞻性伦理问题研究。结论在科技计划项目管理过程中,加强伦理监管既要规范相关科技研究活动,又应不妨碍科技创新发展。针对不同项目可能涉及的伦理风险的差异进行分级审查,并采取分级监管措施,将有效保障科技计划项目的顺利实施。Objective This paper analyzed the current situation and issues of ethical supervision of science and technology projects supported by central financial funds and proposed countermeasures to improve project management.Methods Considering the practical management experience of a key special project during the 13th Five-Year Plan period,this article investigated ethical supervision issues in various stages including guideline preparation,review and approval,process management,and final acceptance,and proposed four levels of review for ethical oversight according to the characteristics of the research projects and the degree of ethical risks involved.Results Firstly,lower-risk projects should still be reviewed by the Institutional Ethics Committee,and the project implementation unit should primarily assume responsibility for ethical supervision and follow-up on the review.Second,in addition to the review by the Institutional Ethics Committee,the Project Management Institution should strengthen ethical supervision and take risk control measures at different nodes for sensitive projects and higher ethical risk projects.Third,projects with large ethical controversies and high-risk projects should be reviewed by the National Science and Technology Ethics Committee and a public participation discussion mechanism for major ethical issues should be established.Finally,it is suggested to conduct prospective ethical studies for cutting-edge new technologies and new fields.Conclusions In the process of managing science and technology program projects,strengthening ethical oversight in the management of science and technology projects should both standardize relevant scientific and technological research activities and not impede the growth of scientific and technological innovation.In view of the differences in ethical risks that may be involved in different projects,hierarchical examination,and supervision measures should be taken to effectively guarantee the smooth implementation of science and technology planning projects.
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