摘要
医疗技术临床应用准入是医疗质量管理的核心制度内容之一,涉及医疗质量保证与患者安全目标实现及医疗服务满意度等.经临床研究验证安全性和有效性,才允许医疗技术应用于临床,并由本医疗卫生机构医疗技术临床应用管理委员会和伦理委员会进行评估和审查.根据相关法律法规和伦理原则,结合一些医疗卫生机构对医疗技术临床应用的伦理审查经验进行专题讨论,制订了医疗技术临床应用伦理审查指引供参考.其从医疗卫生机构准入医疗技术临床应用的管理体系、伦理委员会制度和审查规范要求、技术方案及其审查要点、知情同意实施要点及技术团队与条件等方面给予阐述.
Abstract
Access to the clinical application of medical technology is one of the core institutional contents of medical quality management,involving medical quality assurance,the achievement of patient safety goals,and medical service satisfaction.Medical technology is only permitted for clinical use after its safety and effectiveness have been verified through clinical research,as well as evaluated and reviewed by the medical technology clinical application management committee and ethics committee of this medical and health institution.Based on the relevant laws,regulations,and ethical principles,combined with the experience of ethical review in the clinical application of medical technology from some medical and health institutions,a thematic discussion was held to formulate ethical review guidelines for the clinical application of medical technology for references.These guidelines elaborated on the management system for access to the clinical application of medical technology in medical and health institutions,the system of ethics committees and the requirements of review norms,technical plans and their review points,key points for the implementation of informed consent,technical teams and conditions,and other aspects.
国家科技期刊平台
NSTL
万方数据