CAJ | 학술논문

描述了药物临床试验伦理审查实践中常见的风险因素，从伦理审查机构设置、人员组成、培训、审查程序及监督机制等方面列举了风险的表现形式，分析了伦理审查风险的成因，并提出通过申请并通过国际认证、改进伦理审查机构设置、加大培训力度、引入伦理督查与伦理验收等方法规避风险。
묘술료약물림상시험윤리심사실천중상견적풍험인소，종윤리심사궤구설치、인원조성、배훈、심사정서급감독궤제등방면열거료풍험적표현형식，분석료윤리심사풍험적성인，병제출통과신청병통과국제인증、개진윤리심사궤구설치、가대배훈력도、인입윤리독사여윤리험수등방법규피풍험。
The authors presented in the paper the following subjects: a description of risk exposures commonly found in drug clinical trials; risk types in terms of the personnel organization of ethical review boards, and the composition of the ethical review board members, as well as ethical training, ethical review procedures and supervising of the ethical review. To avoid these risks, an analysis is made on the causes of ethical review risks, and recommendations are proposed on international certification, reform of ethical review board setup, greater efforts on training, introduction of ethical supervision and ethical acceptance procedure.