With the expansion of clinical research projects and drug innovation research and development practice in China, more and more human body participates in clinical trials which also become more and more complicated. Various hospitals and research institutes have established ethics committee in accordance with national policies, regulations and clinical trial ethics management standards and also established review mechanisms. However, in practical work, how to continuously improve the ethical review of clinical trial projects and the protection of subjects remains a lack of systematic induction and summary. On February 22nd, the Center for Medical Research and Ethics of Central South University jointly with the Global Doctors Organization and China Science & Technology Publishing & Media Co., Ltd. (Science Press) held a seminar on “Research Report on Clinical Research Ethics Practice and Subject Protection” in Changsha, and completed the nation's first "Research Report on Clinical Research Ethics Practice and Subject Protection".
Zhang Liming, Deputy Director of the Division of Science and Technology Education of the National Health and Family Planning Commission, Liang Yiheng, Deputy Director of the Hunan Food and Drug Administration, Long Kaichao, Deputy Director of the Hunan Provincial Health Department, Tian Yongquan,Director of the Medical Ethics Research Center of Central South University and Vice President of Central South University , and Luo Aijing, Secretary of the Third Xiangya Hospital of Central South University attended the opening ceremony of the seminar. More than 30 medical ethics experts from Peking Union Medical College Hospital, Cancer Hospital of Chinese Academy of Medical Sciences, Peking University Medical School, Cancer Hospital of Sun Yat-sen University, Nanfang Hospital of Guangdong Province, Shanghai Medical College of Fudan University, Huazhong University of Science and Technology, the three affiliated hospitals of Central South University System and other famous universities gathered to discuss the ethical issues in the ethical practice of clinical research. The seminar was organized by the Third Xiangya Hospital of Central South University, and was chaired by Yuan Hong, deputy director of the Medical Ethics Research Center of Central South University and vice president of Xiangya Third Hospital of Central South University.
At the opening ceremony, Luo Aijing, Tian Yongquan, Long Kaichao, Liang Yiheng and Zhang Liming successively spoke and analyzed the urgency and importance of clinical research ethical practice and subject protection from the hospital, school, and government levels. Zhang Liming made a briefing on the key work of medical ethics in 2014: first, extensive investigations and research to enhance the pertinence of ethical management; second, improving the formulation and implementation of relevant ethical laws and regulations; third, further improving the expert committee to provide better support to ethical management work. Finally, on behalf of the National Science and Education Department of the National Health and Family Planning Commission, he congratulated on the establishment of Center for Medical Ethics Research at Central South University and the achievements it got in a short period of time. He also put forward valuable opinions and suggestions on the seminar.
At the meeting, the participating experts spoke enthusiastically on the “Chinese Ethics Practice of Clinical Research Report” and discussed issues in China’s clinical research practice and raised acute academic opinions and suggestions for revision,such as: the organizational structure of the IRB, the standardized writing of informed consent, the recruitment and management of participants, the compensation of disadvantaged groups, the construction of regional/central ethics, and disputes in science and ethics.
Afterwards, Professor Li Enchang, President of "Chinese Medical Ethics" magazine made a lecture on "Some Issues Concerning the Writing of Medical Ethics Papers." Shi Zhanxiang, Head of China Region for Global Doctors Organization, made a wonderful "Question on Scientific Research Integrity". PPT report.
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