罕见病临床研究中的伦理问题  

Ethical issues on clinical research of rare diseases

作　　者：白桦[1] 张抒扬[2] BAI Hua;ZHANG Shu-yang(Clinical Pharmacology Research Center,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences,Beijing 100730,China;Department of Cardiology,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]中国医学科学院北京协和医院,临床药理研究中心,北京100730 [2]中国医学科学院北京协和医院,心内科,北京100730

出　　处：《临床药物治疗杂志》2019年第11期14-17,23,共5页Clinical Medication Journal

基　　金：国家重点研发计划(2016YFC0901500);中国医学科学院医学与健康科技创新工程资助项目(2016-I2M-1-002);北京协和医学院2018年教学质量工程项目(2018zlgc0116)

摘　　要：罕见病由于诊断治疗困难,在全球范围内都是影响人类健康的重要问题。近年来罕见病的临床研究不断增多,但研究相关的伦理学问题容易被忽视。本文通过分析罕见病人群和罕见病研究的特点,提出罕见病临床研究需要从研究的目的、方案设计、风险收益分析和知情同意等不同环节关注伦理学问题,旨在提高研究者的伦理意识,帮助伦理委员会开展相关审查,最终提高罕见病临床研究的伦理水平。Rare diseases are an important global problem affecting human health due to the difficulty of diagnosis and treatment.The number of clinical researches of rare diseases are increasing,yet ethical issues in these researches were not taken adequate consideration.By analyzing the characteristics of rare disease population and researches,we propose that clinical researches on rare diseases should focus on ethical issues from different aspects,such as research purpose,scheme design,the risk and benefit analysis and informed consent.With the aim of improving the ethical awareness of investigator,and helping ethics committee in carrying out the relevant review,it will eventually improve the level of rare disease clinical research ethics.

关 键 词：罕见病 临床研究 伦理问题 

分 类 号：R597[医药卫生—内科学] R-052[医药卫生—临床医学]