我国药物临床试验机构伦理委员会建设的不足及对策

The Deficiency of the Ethics Committee of Drug Clinical Trial Institution and the Countermeasure

药物临床试验机构伦理委员会是药物临床试验伦理审查的主体机构,目前我国临床试验的伦理审查工作仍存在很多困境。本文关注我国药物临床试验中的伦理困境,着重分析药物临床试验机构伦理委员会建设的不足之处,最终提出明确伦理委员会规则和标准、加强伦理委员会组织建设、完善制度建设等对策,以期提升我国药物临床试验伦理审查水平。

The ethics committee is the main body of the ethical review of drug clinical trial, and there are still many difficulties in the ethical review of clinical trials in China. This article is concerned with the ethical dilemma in drug clinical trials in China, and analyzes the deficiency of the construction of the ethical committee of the drug clinical trial organization. Finally, we put forward the countermeasures to adapt the ethical standards of drug clinical trials in China.