药物临床试验伦理审查工作指导原则-EN.pdf

Translated by RDPAC For RDPAC Member Companies Use Only 药物临床试验伦理审查工作指导原则 （2010-11-02 ） Guidelines for Ethical Review Work of Drug Clinical Trials Chapter I General Provisions Article 1 For the purpose of strengthening the guidance and administration of ethical review of drug clinical trials, and standardizing the activities of the ethical review of ethics committee so as to ensure that drug clinical trials meet the requirements of science and ethics, the guidelines are formulated in accordance with the Good Clinical Practice for Pharmaceutical Products (GCP), the Declaration of Helsinki of the World Medical Association, and the International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organizations of Medical Sciences. Article 2 An Ethics Committee reviews the scientific merits and ethical rationality of drug clinical trials in order to protect research participants’ dignity, safety, rights and interests, to promote the development of drug clinical trials in a healthy and scientific way, and to gain the public’s trust and support in drug clinical trials. Article 3 It must be under the premise of abiding by the State constitution, law, regulations and relevant stipulations that ethics committees conduct ethical review of drug clinical trials independently and shall accept the instructions and administration by drug regulatory departments. Article 4 The drug regulatory departments shall establish the procedures for inspecting and assessing the activities of committees’ ethical review of drug clinical trials, and shall instruct and administer the activities of ethical review. Chapter II Organization and Management of the Ethics Commi