药物临床试验伦理跟踪审查中的问题与对策

Problems and Countermeasures in Ethical Tracking Review of Drug Clinical Trials

伦理跟踪审查是保护临床试验受试者权益的重要手段,我国现阶段伦理跟踪审查仍然存在法律效能低、无标准操作指南、培训不到位、监管体系欠缺、审查资源匮乏等问题。基于此,提出完善相关法规指南、建立规范化培训体系、健全监管体系以及加强伦理委员会基础设施建设等措施,以完善跟踪审查制度,使跟踪审查工作真正切实、有效。

Ethical tracking review is an important mean to protect the rights and interests of the clinical trial subjects. At the present stage of China's ethical tracking,there are still many problems,such as low legal efficiency,no standard operation guide,lack of training,lack of supervision system and lack of resources. Based on this,this paper proposed the measures of improving the guidelines of relevant regulations,establishing a standardized training system,improving supervision system and strengthening the construction of basic facilities of the ethics committee,so as to improve the system of tracking review,so that the work of tracking review is really practical and effective.