人类遗传资源管理在临床试验中的要求和推动作用

Human genetic resource management requirements and its promoting effect in clinical trials

随着国家科技部对人类遗传资源管理工作的不断推进,临床试验中涉及到的人类遗传资源的管理也日趋受到重视。本文主要讲述人类遗传资源在临床试验中的申报与审批、相关制度建立等方面的管理要求,以及该管理对提升伦理审查水平、推动机构建设、明确试验各方责任等方面带来的促进作用。

With the continuous promotion of the ministry of science and technology to the management of human genetic resources, the management of human genetic resources involved in clinical trials has been paid more and more attention. This paper describes the management requirement of application and approval, the relevant system of human genetic resources in clinical trials, and the promoting effect of human genetic resources management in enhancing the ethical review level, promoting the construction of institutions, and clearing the responsibility of all parties to the trial.