生物医学新技术临床应用的伦理治理要点
Key points of ethical governance in the clinical application of new biomedical technology
袁平 1李红娟 2李晓京 2张秀英 3张琼阁 2王宏宇1
作者信息
- 1. 北京大学首钢医院科研处/血管医学中心,北京 100144;北京大学临床研究所心脏和血管健康研究中心,北京 100191;北京大学健康医疗大数据国家研究院智慧化心脏和血管健康数字管理研究中心,北京 100191
- 2. 北京大学首钢医院科研处/血管医学中心,北京 100144
- 3. 北京大学首钢医院医务处,北京 100144
- 折叠
摘要
当前生物医学新技术临床应用中存在未知风险高等伦理问题,医疗机构需建立新技术管理制度,包括明确新技术概念、新技术评估准入机制和伦理管理制度.伦理审查委员会也应该根据所在医疗机构新技术发展方向,完善伦理委员会管理制度和伦理审查委员会成员专业组成,提高伦理委员对生物医学新技术的评审能力,初审阶段加大对新技术伦理风险的评估并加强应急预案制定的要求,按照新技术风险等级设定跟踪审查频率.伦理审查委员会应与医务管理部门一同制定本机构的医疗技术临床应用的伦理规范化培训制度,定期开展全员培训,以推进医务工作者了解生物医学技术的管理要求.不同类型的生物医学新技术存在不同的伦理风险,医疗机构的医务管理部门和伦理审查委员会应根据新技术类型特点制定相应的具体管理规则,但需要注意的是,一般的生物医学新技术刚刚进入临床时,往往均存在技术使用的公平性与正义的问题.
Abstract
Given the current ethical issues such as unknown high risks in the clinical application of new biomedical technology,thus,medical institutions need to establish new technology management systems,including clarifying the concept,the assessment and admission mechanism,and ethical management systems of new technology.According to the direction of the development of new technology in the medical institution,the ethics review committee should also perfect the management system of ethics committees and the professional composition of ethics review committee members,improve the ability of ethics committee members to evaluate new biomedical technology,increase the assessment of ethical risks of new technology in the preliminary review stage,strengthen the requirements for emergency plan formulation,as well as set the frequency of the follow-up review based on the risk level of new technology.The ethics review committee should work together with the medical management department to formulate an ethical standardization training system for the clinical application of medical technology in the institution, and regularly conduct training for all staff, to promote medical workers' understanding of the management requirements of biomedical technologies. Different types of new biomedical technology have different ethical risks. Therefore, the medical management departments and ethics review committees of medical institutions should formulate specific management rules based on the characteristics of new technology types. However, it should be noted that when new biomedical technology generally is first introduced into clinical practice, there are often issues regarding fairness and justice in the use of the technology.
关键词
生物医学新技术/临床应用/患者保护/伦理治理Key words
new biomedical technology/clinical application/patient protection/ethical governance引用本文复制引用
出版年
2025
国家科技期刊平台
NSTL
万方数据