医疗新技术的伦理审查与监管问题研究

Research on Ethical Review and Supervision of New Medical Technology

现如今对医疗新技术的伦理审查模式往往存在责任主体不明确、医疗新技术临床准入不完善,伦理委员会审查监管职能范围受限、定期评估与反馈跟踪审查不持续等方面的问题。同时新技术伦理审查与监管往往后置,并不在研发或产出之前进行监管,而往往在投入使用后才会进行规约,无法有效防范技术风险、保证患者的安全健康。探讨了医疗新技术在飞速发展的同时所出现的一系列亟需疏解的伦理问题,强调并提出了对医疗新技术进行规范的伦理审查与监管的同时又能确保其有序开展的途径。

Nowadays,there are many problems in the ethical review mode of new medical technology,such as unclear responsible subject,imperfect clinical access of new medical technology,limited scope of review and supervision function of ethics committee,no regular evaluation and continuous review,etc.At the same time,ethical review and supervision of new medical technology are often done after its research and development and in the process of its clinical application,which cannot effectively prevent technical risks and ensure the safety of patients.This paper discusses a series of ethical problems of new medical technology,which need to be solved urgently.It also further discusses approaches to ensure ethical review and supervision while ensuring the sound development of new medical technology.