中医临床研究设计中的伦理问题与优化

Ethical issues and optimization of TCM clinical research design

中医临床研究是运用中医药治疗方法,以人体为受试对象进行的临床研究活动,在此过程中必然涉及到受试者的利益与风险,因此中医临床研究中必须重视伦理学问题。在保证安全性和科学性的基础上,对伦理学方案进行优化。文章从中医临床研究中伦理学的若干重要环节入手,阐述了伦理委员会的组成优化、研究方案的伦理审核优化、知情同意过程优化、跟踪审查优化以及受试者的保护与补偿优化,为提高中医临床研究的伦理学质量提供了有益探讨。

TCM clinical research should attach importance on ethical issues,as it takes the human for the research subjects and the clinical research activities definitely involve the benefits and risks to the subjects.Ethics optimization on the basis of safety and scientificity is necessary.This study explores the optimization of some key links of ethics of TCM clinical research,i.e.optimization of ethics committee membership,optimization of ethical review of study protocol,optimization of informed consent process,and optimization of protection and compensation of the subject,thus providing the theoretical support for ethics improvement of TCM clinical research.