I. Provisions of the Civil Code on Human Clinical Trials Article 18 of the Civil Code of the People's Republic of China stipulates that if clinical trials are necessary for the development of new drugs, medical devices or new prevention and treatment methods, the subjects or their guardians shall be informed of the purpose, use and possible risks of the trials with the approval of the relevant competent authorities and the approval of the ethics committee according to law, and their written consent shall be obtained. For clinical trials, no trial fee shall be charged to the subjects.
2. What conditions should clinical trials meet? 1. The purpose of clinical trials is to develop new drugs, medical devices or new prevention and treatment methods; 2. Approved by the relevant competent authorities in accordance with the law and approved by the Ethics Committee; 3. Inform the subject or the subject's guardian of the purpose, purpose and possible risks of the test, and obtain their written consent; 4. No test fee shall be charged to the subjects. 5, a sound data management system, remote backup and other disaster recovery measures. 6. Facilities, equipment, staffing and disposal capacity for critical illness diagnosis and treatment 7. Facilities, equipment, technical echelon and disposal capacity for critical illness diagnosis and treatment. 8, there are management mechanisms and measures to prevent and deal with emergencies in clinical trials. 9, the establishment of emergency green channel and other mechanisms and measures.
3. Requirements for ethical review of clinical trials 1. The choice of ethical review methods meets the requirements of the articles of association. 2. The presiding member shall be arranged reasonably (professionally related or related to ethical issues, with no conflict of interest). 3. The meeting review project will send the materials to the members for pre-examination in advance, and the interval between the date of sending the materials and the date of meeting review is in line with SOP regulations. 4, research project review to fill in the corresponding review worksheet. 5. The review meeting meets the requirements of the quorum. 6. The review meeting shall abide by the regulations on conflict of interest management. 7, should review the scientific, ethical and compliance of clinical trial scheme; Review the risks and benefits of participants participating in clinical trials. 8. Review the recruitment of subjects, the information informed in the informed consent form, the process of informed consent, the medical care and protection of subjects, privacy and confidentiality, especially whether the informed consent involving vulnerable groups, people with special diseases and people/ethnic groups in specific areas meets GCP requirements. 9. Exemption from informed consent and exemption from obtaining informed consent again shall be examined and approved by the Ethics Committee. 1. The standards and procedures for quick review and follow-up review meet the requirements of SOP. 11. When major or serious problems occur during clinical trials, which damage the rights and interests of subjects and endanger the safety of subjects, the ethics committee shall take necessary measures. The above is the relevant content of the provisions of the Civil Code on human clinical trials for everyone. From the above content, we can know that many human clinical trials are voluntarily enrolled, and the analysis can be controlled at this time.