浅析医疗器械临床试验中知情同意的电子化管理

Electronic Management of Informed Consent in Clinical Trials of Medical Devices

对现阶段医疗器械临床试验知情同意环节中,常见的知情同意书内容不完整、审核不统一、签署不规范、保管不重视、过程流于形式等问题进行了归纳总结,并就研究者、受试者在知情同意过程中违规现象和原因进行了探究与分析。究其原因在于当下临床试验知情同意环节监管不足。因此,管理者提出了电子化管理理念,并提出建立医疗器械临床试验管理系统、将虚拟现实和指纹识别技术应用于电子化管理等建议和措施,以期提高医疗器械临床试验中知情同意环节的监管质量。

This paper recapitulates the common problems of informed consent in clinical trials of medical devices, including incomplete informed consent forms, inconsistent review, nonstandard signatures, ignorance of safekeeping of document and formalistic process of informed consent. It also explores and analyzes the phenomena and causes of irregularities stemming from researchers, subjects and regulators, as well as the reason for the lack of supervision in clinical trials. Therefore, the concept of electronic management is offered, and some measures are put forward, such as the establishment of management system and the application of virtual reality and fingerprint identification, so as to improve the quality of supervision of informed consent.