中医药伦理审查的特色与对策探讨
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摘要
中医药是我国医药宝库中的重要组成部分,在世界范围内产生越来越深刻的影响。目前,涉及中医药的临床研究越来越多。任何涉及人的医学研究都不可避免地会给参加研究的受试者带来风险。因此,伦理委员会对中医药相关项目的审查和监督就显得尤为重要。本文简要回顾了中医药伦理审查的建设历程。中医药伦理审查具有其自身特色的,这其中包括中医理论,中草药复方制剂等药物疗法,针灸、拔罐、推拿等非药物疗法等干预方式,以及试验设计、疗效评价、风险与受益等中医药临床研究中的实际问题。针对中医药研究的自身特色,本文提出落实并完善伦理审查制度和程序、提升委员审查能力、优化日常工作流程、提高主要研究者的伦理意识、运用外部认证估推动伦理工作发展等几点对策,不断提升中医药伦理审查的水平,完善受试者保护体系。
Traditional Chinese medicine(TCM) is an important part of traditional medicine in China. It has a profound impact around the world. At present, more and more clinical researches on TCM have been carried on. Any medical research that involves people will inevitably bring risks to subjects participating in the study. Therefore, ethical review and supervision on TCM related projects by the ethical committee are particularly important. This paper briefly reviewed the construction history of TCM ethical review. Characteristics of TCM ethical review including TCM basic theories;intervention methods which contain drug therapy such as Chinese herbs and TCM compound medication, and non-drug therapies such as acupuncture, cupping, massage; as well as experimental design, therapeutic evaluation, risk and benefit in TCM clinical studies. According to TCM characteristics, this paper suggest several countermeasures to constantly improve the ethical review standard of TCM, which included to implement and improve the ethical review systems and procedures, to enhance the review ability of ethical committee members, to optimize daily work processes, to improve the ethical awareness of principal investigator(PI), to use external authentication in the promotion of ethical reviewprotection
Traditional Chinese medicine(TCM) is an important part of traditional medicine in China. It has a profound impact around the world. At present, more and more clinical researches on TCM have been carried on. Any medical research that involves people will inevitably bring risks to subjects participating in the study. Therefore, ethical review and supervision on TCM related projects by the ethical committee are particularly important. This paper briefly reviewed the construction history of TCM ethical review. Characteristics of TCM ethical review including TCM basic theories;intervention methods which contain drug therapy such as Chinese herbs and TCM compound medication, and non-drug therapies such as acupuncture, cupping, massage; as well as experimental design, therapeutic evaluation, risk and benefit in TCM clinical studies. According to TCM characteristics, this paper suggest several countermeasures to constantly improve the ethical review standard of TCM, which included to implement and improve the ethical review systems and procedures, to enhance the review ability of ethical committee members, to optimize daily work processes, to improve the ethical awareness of principal investigator(PI), to use external authentication in the promotion of ethical reviewprotection
引文
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3黄春春,陈昭辉.论医学伦理委员会的意义和发展.中国医学伦理学,2005,18(2):68-70.
4中华人民共和国国家卫生和计划生育委员会.涉及人的生物医学研究伦理审查办法(第11号令),2016.
5国家食品药品监督管理总局、中华人民共和国国家卫生和计划生育委员会.医疗器械临床试验质量管理规范(第25号令),2016.
6中共中央办公厅、国务院办公厅.关于深化审查审批制度改革鼓励药品医疗器械创新的意见,2017.
7汪秀琴,熊宁宁,卜擎燕,等.WHO/TDR操作指南:支持草药产品临床试验所必须的支持信息.中国临床药理学与治疗学,2007,12(3):582-585.
8 Li S M,Costi J M,Teixeira J E.Sham acupuncture is not a placebo.Arch Intern Med,2008,168(9):1011.
9 Forum for Ethical Review Committees in the Asian&Western Pacific Region.SIDCER recognition program 2005-2017.http://www.fercapsidcer.org/recognized.php?Mem_Form=main.
10王艳桥,何燕,罗晓琼,等.临床研究伦理审查体系中伦理委员会设置的探讨.中国医学伦理学,2015,28(6):916-918.
11吴晓瑞,李义庭,赵学志,等.北京地区机构伦理审查委员会现状的调查分析.医学与哲学(人文社会医学版),2010,31(3):11-13.
2翟晓梅,邱仁宗.生命伦理学导论.北京:清华大学出版社,2005:4-5,81.
3黄春春,陈昭辉.论医学伦理委员会的意义和发展.中国医学伦理学,2005,18(2):68-70.
4中华人民共和国国家卫生和计划生育委员会.涉及人的生物医学研究伦理审查办法(第11号令),2016.
5国家食品药品监督管理总局、中华人民共和国国家卫生和计划生育委员会.医疗器械临床试验质量管理规范(第25号令),2016.
6中共中央办公厅、国务院办公厅.关于深化审查审批制度改革鼓励药品医疗器械创新的意见,2017.
7汪秀琴,熊宁宁,卜擎燕,等.WHO/TDR操作指南:支持草药产品临床试验所必须的支持信息.中国临床药理学与治疗学,2007,12(3):582-585.
8 Li S M,Costi J M,Teixeira J E.Sham acupuncture is not a placebo.Arch Intern Med,2008,168(9):1011.
9 Forum for Ethical Review Committees in the Asian&Western Pacific Region.SIDCER recognition program 2005-2017.http://www.fercapsidcer.org/recognized.php?Mem_Form=main.
10王艳桥,何燕,罗晓琼,等.临床研究伦理审查体系中伦理委员会设置的探讨.中国医学伦理学,2015,28(6):916-918.
11吴晓瑞,李义庭,赵学志,等.北京地区机构伦理审查委员会现状的调查分析.医学与哲学(人文社会医学版),2010,31(3):11-13.