Expand the organizational structure of the ethics Committee of institutional clinical trials;
(1) The clinical trial ethics committee is a permanent institution of the hospital, which carries out its daily work under the guidance and assistance of the hospital.
(2) The clinical trial ethics committee independently examines and supervises the clinical research on drugs, medical devices and diagnostic reagents involving human bodies carried out by hospitals.
(3) The review of clinical research by the Ethics Committee is independent, and the work of the Ethics Committee is not influenced by any trial participants. Other departments and individuals shall not modify the final evaluation decision of the Committee meeting, and the chairman shall not change the decision rejected by the Committee meeting.
(4) The hospital provides funds, personnel and venue support for the normal work of the Ethics Committee, and provides sufficient meeting and office space and necessary equipment and facilities, including filing cabinets, computers, photocopiers and fax machines.
(5) The appointment of the chairman shall be discussed by the Academic Affairs Office and a letter of appointment shall be issued.
The expansion of the main responsibilities of the ethics Committee;
Review the scientific and ethical rationality of biomedical research projects involving people, including initial review, follow-up review and review, in order to protect the dignity, safety and legitimate rights and interests of subjects.