我国器官移植伦理委员会伦理审查能力建设  

Capacity Building of Ethical Review of Organ Transplantation Ethics Committee in China

作　　者：郑金[1] 江一峰[2] 周吉银 ZHENG Jin;JIANG Yifeng;ZHOU Jiyin(Department Scientific Research,the Third Hospital of Hebei Medical University,Shijiazhuang 050051,China;Ethics Office of Shanghai First People's Hospital,Shanghai 200080,China;National Drug Clinical Trial Institution,the Second Affiliated Hospital of Army Medical University,Chongqing 400037,China)

机构地区：[1]河北医科大学第三医院科研处,河北石家庄050051 [2]上海市第一人民医院伦理办公室,上海200080 [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

出　　处：《中国医学伦理学》2022年第6期607-612,共6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);河北省教育厅2016年河北省高等学校科学研究计划项目“探究医学科研项目伦理审查管理新模式”(SZ16250);2020年度河北省社会科学发展研究课题“医学伦理审查信息公开与科普社会服务能力建设研究”(20200303116)。

摘　　要：中国人体器官移植技术临床应用与伦理委员会建设正不断完善提高。人体器官移植技术临床应用与伦理委员会审查应遵循审慎原则,其具有及时性要求高,准备工作繁琐,活体器官移植需权衡供者、受者双方风险受益比等特点。根据中国当前人体器官移植技术临床应用与伦理委员会常存在的问题,如缺乏监管和指导,无统一标准操作规程,公民逝世后器官捐献者权益被重视程度不够,脑死亡判定落实难,缺乏心理评估要求及程序,知情同意不到位等。可尝试从以下层面加以解决,包括确保独立的伦理审查,加强活体器官移植供者、受者双方的风险受益比评估,审查内容的标准化,严格落实知情同意,医学心理评估以降低双方风险,丰富审查方式确保时效性,加强器官捐献的伦理审查和监督。The construction of clinical application and ethics committee of human organ transplantation technology is constantly improving in China.The review of clinical application and ethics committee of human organ transplantation technology should follow the principle of prudence,with high requirements for timeliness and cumbersome preparation,and living organ transplantation needs to weigh the risk benefit ratio of both donors and recipients.According to the problems often existing in China's clinical application and ethics committee of human organ transplantation technology,such as lack of supervision and guidance,lack of unified standard operating procedures,insufficient attention to the rights and interests of organ donors after citizens'death,the difficulties to judge and implement of brain death,lack of psychological assessment requirements and procedures,inadequate informed consent,etc.It can be solved from the following aspects:ensuring the independence of ethical review,strengthening the risk benefit ratio assessment of both donors and recipients of living organ transplantation,standardizing the review content,strictly implementing informed consent and medical psychological assessment to reduce the risks of both sides,enriching review methods to ensure timeliness,and strengthening the ethical review and supervision of organ donation.

关 键 词：器官移植 器官捐献 伦理审查 伦理委员会 

分 类 号：R-052[医药卫生]