ABSTRACT
Human genetic resources include specimen samples and related information. The application and regulation of human genetic resources in China started at the end of the 20th century and have progressed rapidly. However， many challenges remain. In this paper， we reviewed the current status of sample conservation and management and provided recommendations for further development of human genetic resources in China. The aim is to effectively protect and rationally utilize China's human genetic resources， safeguard national security and people's health， and promote the building of a community of common health for mankind.
ABSTRACT
Human genetic resources are an important strategic resource for the development of science and technology in China. In order to fully utilize and effectively protect human genetic resources in real-world studies, through analyzing the status and characteristics of real-world studies, this study found that the number of real-world studies was increasing year by year, and with some characteristics, such as many uncontrollable factors, strict requirements for evidence formation, and easy information acquisition and disclosure. Combined with the characteristics of real-world studies, the ethical issues of human genetic resource management in real-world studies were summarized into three aspects, including scientific and value of research development, informed consent and privacy protection of subjects, and fairness and justice in benefit sharing. Accordingly, the key points of ethical review were proposed as scientific rationality, fully informed consent and privacy, as well as data security and stakeholders. In addition, it is necessary to give full play to the role of ethical review in research access and process supervision responsibilities, guide researchers to make full use of human genetic resources by strengthening training and process management, and further promote the standardization of real-world studies.