|Comprehensive Analysis of Ethical Review Opinions on Clinical Trials ofMedical Devices
|中文关键词: 伦理审查 志愿者 申办者 医疗器械 临床试验研究
|英文关键词: ethical review volunteer sponsor medical devices clinical trial
| Objective: To provide reference for the preparation of ethical review materials for future clinicaltrials of medical devices by studying the initial ethical review opinions of clinical trials of diff erent registrationclassifi cations of medical devices. Methods: The initial ethical review opinions of the ethics committee of Beijingluhe Hospital Affi liated to Capital Medical University from 2018 to 2023 on clinical trial of medical devices wereretrospectively collected, and the problems were classifi ed, and the diff erences in the incidence of diff erent typesof problems in clinical trial of medical devices with diff erent registration classifi cations and before and after thepromulgation and implementation of the new version of "Quality Management Standards for Clinical Trial ofMedical Apparatus and Instruments" were compared. Results: A total of 50 initial ethical reviews were collected,focusing on issues related to informed consent, safety and benefi ts 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 showeda signifi cant downward trend after the implementation of the new version of the "Quality Management Standardsfor Clinical Trial of Medical Apparatus and Instruments". Conclusion: The article suggests that the relevantpractitioners must put the rights and interests of the volunteerts in the first place when preparing the ethicalmaterials for clinical trials, and constantly update their understanding of laws and regulations to standardize theethical declaration of the project.