新时代中医药临床研究伦理审查工作的守正创新——无锡市中医医院伦理审查体系建设实践

Integrity and Innovation of Ethical Review in Clinical Research of Traditional Chinese Medicine in the New Era:Practice on the Construction of Ethical Review System in Wuxi Traditional Chinese Medicine Hospital

在新时代科技创新大背景下,中医药伦理审查面临新的机遇与挑战。围绕中医医疗机构中医药临床研究伦理审查工作如何守正创新,从中医药临床研究创新与传承的特点出发,论述中医药临床研究伦理审查体系建设、关注要素、短板与不足、培训与交流等,并提出共同创建中国特色科技伦理治理体系建设,应考虑中医药临床研究可利用现代化技术手段对辨证论治、经方项目再评价或扩大适应证等科技项目伦理审查的特色要求;创新审查形式,加强伦理审查的过程管理;科学、客观、公正地评价中医药临床研究项目科学性及社会价值;重视中药,特别是复方制剂的毒副作用等几点建议,旨在进一步提高中医药临床研究伦理审查的程序规范和审查质量,保障受试者合法权益和安全,促进祖国医学的发展。

Under the background of scientific and technological innovation in the new era,ethical review of traditional Chinese medicine(TCM)is facing new opportunities and challenges.Focusing on how to maintain integrity and innovation in the ethical review work of TCM clinical research in TCM medical institutions,starting from the characteristics of innovation and inheritance of TCM clinical research,this paper discussed the construction of the ethical review system of TCM clinical research,key elements of attention,shortcomings and deficiencies,training and communication,etc.It is also proposed that the joint construction of a Chinese characteristic scientific and technological ethics governance system should consider the unique requirements of modern technological means for the ethical review of scientific and technological projects such as dialectical treatment,re-evaluation of prescription projects,and expansion of indications in clinical research of TCM;innovate the form of review and strengthen the process management of ethical review;scientifically,objectively and impartially evaluate the scientific nature and social value of clinical research projects in TCM;pay attention to the toxic side effects of TCM,especially compound preparations.So as to further improve the procedural norms and quality of ethical review of clinical research of TCM,protect the legitimate rights and interests and safety of subjects,and promote the development of medicine in China.