T/CACM 015.2-2017 The establishment of standards for ethics review procedures for clinical research on traditional Chinese medicine

Scope

Main technical content: With the rapid development of biomedical research and the gradual deepening of ethical review work, the National Medical Products Administration and the National Administration of Traditional Chinese Medicine have successively issued biomedical ethical review methods and normative documents involving humans since 2010. In October 2016, the National Health and Family Planning Commission promulgated the "Ethical Review Methods for Biomedical Research Involving Humans" (Decree No. 11), which officially came into effect on December 1. The newly promulgated "Methods" (Decree No. 11) comprehensively plan the system construction, further refine the content and procedures of ethical review and informed consent, strengthen the legalization of ethical review work involving biomedical research involving humans, further clarify the legal responsibilities of ethical review, and better protect the legitimate rights and interests of subjects. This standard, in accordance with relevant domestic laws and regulations, and under the guidance of related laws, regulations, and documents such as Decree No. 11, combines the characteristics of clinical research on traditional Chinese medicine and the needs of ethical review operations to form norms for the formulation of standard operating procedures for ethical review, providing a reference for the formulation of standard operating procedures by ethics committees

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