Common Problems of Informed Consent in Medical Equipment Clinical Trials and Relevant Solutions
YANG Chun-mei, YUAN Dan-jiang
Institute of Pharmaceutical Clinical Trials, Jingzhou Central HospitaI, Tongji Medical College, Huazhong University of Science and Technology, Jingzhou Hubei 434020, China
Abstract：This paper analyzed the problems of informed consent during medical equipment clinical trials, including the poor writing, nonstandard signing, formalized content and loss of signed informed consent. Moreover, this paper also discussed relevant solutions to improve the writing of informed consent, ethical reviews and file management, regulate the researchers’ behavior and strengthen the awareness of protecting the right of informed consent.
杨春梅，袁丹江. 医疗器械临床试验中知情同意常见的问题与对策[J]. 中国医疗设备, 2015, 30(6): 148-150.
YANG Chun-mei, YUAN Dan-jiang. Common Problems of Informed Consent in Medical Equipment Clinical Trials and Relevant Solutions. China Medical Devices, 2015, 30(6): 148-150.
