从保护受试者权益的角度探讨药物临床试验的伦理审查

目的：从保护受试者权益的角度出发，探讨国内药物临床试验的伦理审查，并提出可行性建议，为各医院伦理委员会的建设提供参考。方法：通过总结国内药物临床试验的伦理审查现状，结合我院药物临床试验机构的实际工作，研讨提高伦理审查能力的方法。结果与结论：我国现行的伦理审查程序存在审查标准有较大差异、审查功能发挥不足、审查过程流于形式及缺乏独立性等问题。通过建立完善的标准操作规程、建立并不断完善伦理审查标准、推动并加强持续审查、联合多部门协同审查、获取国际伦理协会认证及加强培训等方面，提高医院伦理委员会的审查能力及水平，确保临床试验的科学性和伦理道德性。

Discussion on Ethical Review of Drug Clinical Trials from the Perspective of Protecting the Rights and Interests of Subjects

Objective:To Discuss the ethical review of domestic drug clinical trials from the perspective of protecting the rights and interests of the subjects, to put forward feasible suggestions, and to provide references for establishing the ethics committees in hospitals. Methods:By summarizing the current status of ethical review of domestic drug clinical trials, combining with the work of drug clinical trial institutions in our hospital, methods of improving the ethical review ability were discussed. Results and Conclusion:The current ethical review protocol in China has some problems, including significant differences in the review criteria, inadequate performance of the review function, formalized review process, and lack of independence, etc. The review level and ability of the hospital ethics committee would be improved by establishing a complete standard operating procedure, establishing and continuously improving ethical review standards, promoting and strengthening continuous review and multi-department joint reviewso as to acquire international ethics association certification and strengthen training in order to ensure the scientificity and ethicality of the clinical trials.