Shanghai regional ethics committee was approved to be established!

Source: era of medicine 2017-12-13 I Basic Information On December 8, 2017, "Shanghai clinical research ethics committee (Preparatory)" (hereinafter referred to as "clinical research ethics committee (Preparatory)") was officially established with the approval of Shanghai Health and Family Planning Commission (hereinafter referred to as "health and Family Planning Commission") It is mainly responsible for the ethical review of medical clinical research projects involving human body, to ensure that clinical research conforms to ethical principles, and to guarantee the subjects Rights and interests The clinical research ethics committee (Preparatory) is an affiliated institution of Shanghai pharmaceutical clinical research center (hereinafter referred to as "the center"), which is jointly constructed by the health and Family Planning Commission and the Xuhui District People's government II Policy basis The general office of the CPC Central Committee and the general office of the State Council issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices on October 8, which pointed out that local governments can set up regional ethics committees as needed to guide the ethical review of clinical trial institutions, and can accept the entrustment of institutions or registered applicants who do not have the conditions for ethical review to conduct ethical review of clinical trial schemes To review and supervise the clinical trials Clinical research ethics committee (Preparatory) is set up to meet the requirements of opinions III The experience foundation of the independent ethics committee was established in 2008 in order to promote and promote the center's further innovative research in line with international norms and technical ethics standards, protect the rights, safety and welfare of research participants, and meet the needs of the rapid development of biomedical research in China
As the first independent ethics review organization in China, the independent ethics committee of the center has made breakthroughs in ethics review, ethics training and capacity building, foreign exchange and cooperation, policy consultation, etc through its work in the past nine years, and has formed four distinctive characteristics of independence, complementarity, academic and forward-looking, which has certain regional ethics review work The foundation and ability of General process the ethics review process of the general process independent ethics committee is divided into four steps: project acceptance, ethics review, decision communication and document filing If the review cycle is in the form of meeting review, the general cycle is 30 working days from acceptance to decision communication; if the review cycle is in the form of quick review, the general cycle is 15 working days from acceptance to decision communication Detailed procedures Note: the specific review form will be determined according to the project situation In the absence of special circumstances, the ethical review meeting is generally arranged in the last week of each month On the independent ethics committee: 1 Establishment and growth In order to standardize the application of biomedical research and related technologies involving human beings, safeguard the dignity, rights, safety and interests of human subjects, strengthen the guidance, supervision and management of the ethical review of clinical trials, standardize the ethical review of clinical trials, ensure that clinical trials meet the requirements of science and ethics, promote the benign interaction between science and ethics, and enable the medical science in China to Healthy and orderly development, Shanghai pharmaceutical clinical research center in October 2008 in accordance with the World Health Organization's "work guide of the Ethics Committee for biomedical research review", UNESCO's "World Declaration on Bioethics and human rights", the Ministry of health of China's "ethical review method for biomedical research involving human beings" and the "drug clinical" issued by the State Food and drug administration The independent ethics committee was established and operated in accordance with the established standard operating procedures Its composition and operation fully follow the guidelines of the international independent ethics committee At present, the independent ethics committee has entered the third session Professor Zhu Wei of the new commission is the chairman of the committee, who takes the lead in the work of the independent ethics committee Professor Hu Qingli and Professor Shen Mingxian are honorary directors and honorary deputy directors, who participate in the operation of the Committee Other members include well-known ethics experts, statistical experts, clinicians, senior professors, legal experts and social figures The office of independent ethics committee of Shanghai pharmaceutical clinical research center is located in Shanghai pharmaceutical clinical research center The independent ethics committee abides by the national constitution, laws and various national policies, respects social morality and the fine moral tradition of the Chinese nation, draws on the most advanced bioethics achievements at home and abroad, adheres to the combination of theory with practice, unites experts in various related fields and people from all walks of life, and actively works to safeguard the health rights and interests of subjects and citizens 2 The standard operating procedures are formulated in accordance with 1 Law of the people's Republic of China on medical practitioners (1999) 2 Measures for ethical review of biomedical research involving human beings (health and Family Planning Commission, 2016) 3 Code for clinical trial management of drugs (CFDA, 2003) 4 Declaration of Helsinki (2013) 5 Code for the quality management of clinical trials of drugs (ICH, 1996) 6 Guidelines for the work of the Ethical Committee for the evaluation of biomedical research (who, 2000) 7 International ethical guidelines for biomedical research involving human subjects (CIOMS, 2002) 8 The independent ethics committee of the World Declaration on Bioethics and human rights (UNESCO, 2005) formulates standard operating procedures according to the above regulations and guidelines, and takes them as the basis for its work The ethical review of biomedical research involving people is organized in accordance with the corresponding standard operating procedures 3 The basic working principles for the establishment and operation of the independent ethics committee of principles and functions are: legality, impartiality, independence, qualification, pluralism, transparency, timeliness and non-profit Following the principles of justice, independence, pluralism, transparency and non-profit, the independent ethics committee of Shanghai pharmaceutical clinical research center mainly undertakes the following functions: 1 Providing fair and independent ethical review for biomedical research projects involving people; 2 Providing training and continuing education for relevant personnel of clinical research; 3 To study the ethical issues in biomedical research at home and abroad, and propose policies and regulations; 4 Actively participate in medical ethical activities at home and abroad, and strengthen exchanges at home and abroad 4 Science and Ethics: China's "quality management standards for clinical trials of drugs", the "Declaration of Helsinki" of the World Medical Association, and the "international ethics guide for biomedical research of human body" of the International Committee of Medical Sciences (CIOMS), have formulated and established the ethical and scientific standards for biomedical research of human body Scientific review and ethical review are inseparable: unscientific research involving human subjects is immoral in itself The purpose of the independent ethics committee's review of biomedical research is to protect the rights and security of the subjects According to the above guidelines, the independent, competent and timely ethical review of biomedical research projects of human body should be carried out under the premise of scientificity When necessary, the ethics committee can invite experts or / and representatives of special groups to provide consultation Chairman of the third independent ethics committee: Zhu Wei Professor of Applied Ethics Center and Social Science Foundation Department of Fudan University; special researcher of health development center of Shanghai Academy of Social Sciences; member of independent ethics committee of pediatric hospital affiliated to Fudan University; member of Preparatory Committee of bioethics Professional Committee of Chinese society of Dialectics of nature; Honorary Director: Hu Qingli Former assistant director general and deputy director general of the World Health Organization; former member of the International Bioethics Committee of UNESCO; lifelong professor of Pediatrics, Ruijin Hospital Affiliated to Shanghai Jiaotong University Medical College; member of the medical ethics Expert Committee of the national health and Family Planning Commission; honorary deputy director: Shen Mingxian Researcher, Institute of philosophy, Shanghai Academy of Social Sciences; director of ethics department, South research center of national human genome; part-time professor, doctoral supervisor, School of life sciences, Shanghai Jiaotong University; Member: researcher Wu Rong, Fudan University; Associate Professor Deng Wei, Fudan University; Wang Yanyan Deputy chief physician, Xuhui District Central Hospital; Xiong Yan, researcher, Shanghai life science information, Chinese Academy of Sciences; Cao Guoying, Ph.D., Huashan Hospital, Fudan University; Wang Shangshang, dermatologist, Huashan Hospital, Fudan University; Liu Wenjuan, deputy chief physician, Xuhui District Central Hospital, Shanghai; Ying Jianzhong Intermediate lawyer, freelance writer, financial commentator; Chen Jianbo intermediate lawyer, Shanghai Junlan law firm; Li Jing, deputy chief physician, East China Hospital Affiliated to Fudan University; Honorary Consultant: Professor Qiu Xiangxing, Medical College of Shanghai Jiaotong University; Professor Jin pihuan, Fudan University Secretary: Zhang Hongxia, master of Chinese international education, Shanghai pharmaceutical clinical research center.