Objective:To provide reference for the preparation of ethical review materials for future clinical trials of medical devices by studying the initial ethical review opinions of clinical trials of different registration classifications of medical devices.Methods:The initial ethical review opinions of the ethics committee of Beijing luhe Hospital Affiliated to Capital Medical University from 2018 to 2023 on clinical trial of medical devices were retrospectively collected,and the problems were classified,and the differences in the incidence of different types of problems in clinical trial of medical devices with different registration classifications and before and after the promulgation and implementation of the new version of"Quality Management Standards for Clinical Trial of Medical Apparatus and Instruments"were compared.Results:A total of 50 initial ethical reviews were collected,focusing on issues related to informed consent,safety and benefits of volunteerts.The incidence of the two types of problems was 80.00％and 66.00％respectively.Meanwhile,the incidence of the two types of problems showed a significant downward trend after the implementation of the new version of the"Quality Management Standards for Clinical Trial of Medical Apparatus and Instruments".Conclusion:The article suggests that the relevant practitioners must put the rights and interests of the volunteerts in the first place when preparing the ethical materials for clinical trials,and constantly update their understanding of laws and regulations to standardize the ethical declaration of the project.
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NSTL
维普
万方数据
