Abstract：Human genetic resources are the key resources to carry out life science research. It is very important to standardize the management of human genetic resources in clinical research. Based on the self-examination of human genetic resources management and the accumulation of daily work experience, the Affiliated Hospital of Guizhou Medical University found the following risk points of human genetic resources management in clinical studies: lack of awareness of sponsors/researchers in reporting and unclear types of reporting; the estimate of the number of biological samples required for the test is unreasonable, the collection purpose is not specific, and the supervision of the use is not comprehensive; the rationality of clinical research intellectual property ownership is not in-depth, and the fairness of the distribution of experimental results needs to be enhanced. Based on the above risks point analysis, strengthen the education of the human genetic resources, enhance the consciousness of the declaration, improve the level of scrutiny, clear responsibilities, strengthen the daily supervision, from the four stage of clinical research project initation, start, development and completion, establish and improve the human genetic resources to further improve human genetic resources management system.
李琴* 周岩* 刘琳 张倩 李娜 何艳. 临床试验中人类遗传资源管理的风险防控分析及应对措施[J]. 中国医药导报, 2022, 19(32): 193-196.
LI Qin* ZHOU Yan* LIU Lin ZAHNG Qian LI Na HE Yan. Risk prevention and control analysis of human genetic resources management and countermeasures in clinical trials. 中国医药导报, 2022, 19(32): 193-196.
京公网安备 11010502046598号