医疗技术临床应用的伦理审查问题及建议  

Problems and Proposal of Ethical Review on Clinical Application of Medical Technology

作　　者：刘璐 张秋菊 刘丹 郑金[4] 周吉银 LIU Lu;ZHANG Qiuju;LIU Dan;ZHENG Jin;ZHOU Jiyin(Department of Gastroenterology,the Second Affiliated Hospital,Army Medical University,Chongqing 400037,China;School of Basic Medicine,Air Force Medical University,Xi'an 710032,China;National Drug Clinical Trial Institution,the Second Affiliated Hospital,Army Medical University,Chongqing 400037,China;Scientific Research Office,the Third Hospital of Hebei Medical University,Shijiazhuang 050051,China)

机构地区：[1]陆军军医大学第二附属医院消化科,重庆400037 [2]空军军医大学基础医学院,陕西西安710032 [3]陆军军医大学第二附属医院国家药物临床试验机构,重庆400037 [4]河北医科大学第三医院科研处,河北石家庄050051

出　　处：《中国医学伦理学》2023年第1期33-40,共8页Chinese Medical Ethics

基　　金：2019年陆军军医大学人文社会科学基金重点项目“伦理倾销对我国的危害及防范研究”(2019XRW04);2020年陆军军医大学人文社会科学基金一般项目“我国临床研究利益冲突管理的现状与对策研究”(2020XRW10)。

摘　　要：随着中国医疗技术由“准入管理”改为“备案管理”,作为主体责任的医疗机构,通过规范的伦理审查和监管是非常必要的。但目前存在诸多问题,如无医疗技术临床应用伦理审查法规和指导原则,缺乏医疗技术伦理审查标准操作规程,审查能力不足,伦理审查方式的选择缺乏规范,知情同意书要素及其审查有待探讨,缺乏适合的跟踪审查模式,以及技术团队成员和科室资质的确认归口未明确。为维护患者安全和权益,有必要采取以下措施,包括医疗机构全过程监管;明确监管流程,健全多部门间沟通协作机制;设立医疗技术临床应用管理委员会;规范医疗技术伦理委员会的审查制度;明确递交伦理审查的资料清单;实施分类伦理审查和监管以提高效率;探索跟踪审查模式,确保全过程监管;开展普及性和专业性的伦理培训。伦理委员会审查中更要重视审查要点,如技术方案、知情同意书、技术团队成员和科室资质、管理制度、风险评估和应急预案、患者的赔偿等其他材料。在保障患者安全和权益的同时,也有助于促进医疗技术的良性健康发展。With the change of medical technology from“access management”to“filing management”in China,it is necessary for medical institutions,as the main responsibility,to pass standardized ethical review and supervision.However,there are many problems at present,such as the absence of regulations and guidelines for ethical review of clinical application of medical technology,the lack law of medical technology ethical review standard operating procedures,the insufficient review capacity,the lack of standardization in the choice of ethical review methods,the elements of informed consent and its examination need to be discussed,the lack of appropriate continuing review mode,as well as the confirmation of technical team members and department qualifications is not clearly defined.In order to safeguard the safety and rights of patients,it is important to take the following measures,including carrying out the whole-process supervision of medical institutions,clarifying the supervision process,improving the multi-departmental communication and cooperation mechanism,establishing a management committee for clinical application of medical technology,standardizing the review system of the medical technology ethics committee,clarifying submit the list of materials for ethical review,implementing classified ethical review and supervision to improve efficiency,exploring the tracking review mode,ensuring the whole-process supervision,and carrying out popular and professional ethics training.In the review of ethics committee,more attention should be paid to the main points of review,such as technical scheme,informed consent,qualifications of technical team members and departments,management system,risk assessment and emergency plan,patient compensation and other materials.While ensuring the safety and rights of patients,it also helps to accelerate the healthy development of medical technology.

关 键 词：医疗技术 临床应用 伦理审查 伦理委员会 

分 类 号：R-052[医药卫生]