我国药物临床试验机构与伦理委员会的职责界定

Clarifying the Responsibilities of Drug Clinical Trial Institution and Ethics Committee in China

目的:明确我国药物临床试验机构与伦理委员会的职责,为药物临床试验管理工作的改进提供参考。方法:总结我国药物临床试验机构与伦理委员会职责冲突的表现,分析其原因并提出建议。结果与结论:我国药物临床试验机构与伦理委员会的职责冲突,主要表现在伦理审查资料递交主体不明确、多中心伦理审查职责界定不清、跟踪审查的管理普遍存在衔接力度不够等方面。可采取三个方面的措施,包括二者就职责分工达成协议;借鉴国外先进理念,完善我国的相关法律法规;深化管理,促进政策、协议的切实执行。以此来进一步明确药物临床试验机构与伦理委员会的职责,提升药物临床试验管理水平。

OBJECTIVE：To clarify the responsibilities of drug clinical trial institution and ethics committee in China,and to provide reference for the improvement of drug clinical trial management. METHODS：The responsibility conflicts between drug clinical trial institution and ethics committee were summarized,and its reasons were analyzed to provide suggestions. RESULTS CONCLUSIONS：The responsibility conflicts have been found between drug clinical trial institution and ethics committee,mainly manifesting as the essential person who submits protocol is not clear;the responsibilities in multicenter ethics investigation are controversial;the management of their track issues are not connected enough. 3 aspects of measures can be adopted,including reaching an agreement of responsibility assignment learning from foreign advanced ideas,improving laws and regulations;enhancing the management,promoting the implementation of policy and agreement. So,the responsibilities of drug clinical trial institution and ethics committee can be further clarified to improve the management of drug clinical trial.