The number of the institutional ethics review committee shall not be less than 7. The composition of the ethics committee shall include medical professionals, non-medical professionals, legal experts and people independent of the research/experimental unit who have no administrative affiliation with the hospital.
1. Organizational structure of ethics committee
1) Clinical trial ethics committee is a permanent institution of the hospital, which carries out daily work under the guidance and assistance of the hospital.
2) The clinical trial ethics committee provides independent review and supervision for the clinical research of drugs, medical devices and diagnostic reagents involving human bodies carried out by hospitals.
3) The ethics committee is independent in reviewing clinical research, and its work is not influenced by any trial participants. Other departments and individuals may not modify the final review decision of the Committee meeting, and the chairman may not change the decision rejected by the Committee meeting.
4) The hospital provides funds, personnel and venue support for the ethics committee to carry out its normal work, and provides sufficient meeting, 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 president's office meeting, and a letter of appointment shall be issued.
2. Composition of the Ethics Committee
1) The Ethics Committee has one chairman, one or two vice-chairmen and several members. The number of all members of the Ethics Committee shall not be less than 7, and the personnel composition shall include medical professionals, non-medical professionals, legal experts and personnel independent of the research/experimental unit who have no administrative affiliation with the hospital. They are independent in reviewing, making suggestions and making decisions.
2) Members need to have different academic backgrounds.
3) Members should have a balanced gender, and the number of male or female members should not be less than 1/3 of all members.
4) If necessary, an independent consultant who meets the academic background and professional knowledge required for reviewing clinical trial projects can be hired.
5) The ethics committee shall have an ethics secretary, and may temporarily hire staff when necessary.
3. Basis for ethical review
1) The ethical review standard in the Quality Management Standard for Drug Clinical Trials issued by National Medical Products Administration (NMPA).
2) Ethical review norms in the Regulations on Clinical Trials of Medical Devices promulgated by the former china food and drug administration (CFDA).
3) guiding principles for ethical review of drug clinical trials issued by cfda (21).
4) Measures for Ethical Review of Biomedical Research Involving People promulgated by the National Health and Family Planning Commission (216).
5) Ethical principles in the latest edition of Helsinki Declaration.
6) the ethics Committee refers to CIOMS, ICH-GCP.
7) standard operating procedures established by the ethics Committee with reference to WHO's "operational guidelines for the ethical review Committee of biomedical research review" (21) and the above laws and guidelines.