Study on the Protection of the Rights and Interests of Tumor Subjects in Clinical Trials in the Prevention and Control of the COVID -19 / 中国医学伦理学

The outbreak of the COVID -19 has had a big impact on the implementation of clinical trials of tumor drugs and the prevention and control measures such as traffic control and home isolation has caused clinical trials couldn’t proceed normally, so the protection of tumor subjects in clinical trials faces many new challenges. Based on Western and Chinese policies and guidelines on the management of clinical trials during the COVID -19, this paper expounded the impacts of the COVID -19 on tumor patients and tumor clinical trials, analyzed the challenges faced by the protection of tumor subjects in the prevention and control of the COVID -19, and then protected tumor subjects from aspects of optimizing the allocation of health resources, improving non-face-to-face informed consent procedures, strengthening subject visit management, and enhancing clinical trial safety evaluation. It is hoped that these optimization measures can face the future and continue to protect subjects after the end of the epidemic or in new public health emergencies.

The Relevant Regulations of Vulnerability in Foreign Biomedical Research Ethics and Its Enlightenment to China / 中国医学伦理学

The advancement of medicine and biotechnology is based on biomedical research. The rights and safety protection of subjects in biomedical research is one of the core issues of research ethics,and the protection of vulnerable subjects should be the top priority importantly,research ethics should provide special protection for vulnerable subjects. Chinese laws and regulations have not yet given a clear definition of the concept of vulnerability,and the content and regulations related to vulnerability are relatively rough and not perfect. By drawing on the main international and foreign research ethics policies and guidelines,introducing the definition of vulnerability,clarifying the source of vulnerability,and applying vulnerability to the process of biomedical research in China. When applying vulnerabilities,one should avoid using the label approach to include people with common characteristics into vulnerable groups,but mainly analyze the types and sources of vulnerability,and includes as many vulnerable subjects of different types as possible to provide them with more comprehensive and adequate protection in biomedical research.