Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.
Front Public Health. 2021 Aug 19;9:657804. doi: 10.3389/fpubh.2021.657804. eCollection 2021.
Our objective is to explore the effect of applying cloud video conferencing methods to the informed consent process in an early-phase clinical trial during the COVID-19 pandemic. All participants who intended to participate in the trial were informed via a cloud video conference before signing the informed consent forms (ICF). Then, the attitudes of the participants with the cloud video conference and their understanding of the trial were evaluated using a questionnaire when they visited to sign the ICF onsite. A total of 165 subjects participated in the cloud video conference process, and 142 visited the site to sign and date the ICFs at the center during the appointment time. The survey showed that nearly 100% of the subjects evaluated the video-based informed consent process as very good or good and gave correct answers to questions about the trial. Furthermore, 136 (95.8%) subjects believed that the knowledge about the trial derived via the video-based informed consent process was consistent with the onsite reality, and 139 (97.9%) subjects expressed their willingness to participate in an informed consent procedure undertaken through an online video conference. The video-based informed consent process achieved the same effects as an onsite informed consent process. The former saves time and cost of transportation for the subject and exhibits good public acceptance; especially in light of the COVID-19 pandemic, this process is conducive for reducing the risk of subject infection due to travel and would also help avoid crowding on site.
我们的目的是探索在 COVID-19 大流行期间，将云视频会议方法应用于早期临床试验知情同意过程中的效果。所有计划参与试验的参与者在签署知情同意书（ICF）之前，都通过云视频会议进行了通知。然后，当参与者在预约时间到中心现场签署并注明 ICF 时，使用问卷评估他们对云视频会议的态度以及对试验的理解。共有 165 名受试者参加了云视频会议过程，其中 142 名受试者在预约时间到中心现场签署并注明 ICF。调查显示，近 100%的受试者将基于视频的知情同意过程评估为非常好或好，并对关于试验的问题给出了正确答案。此外，136（95.8%）名受试者认为通过基于视频的知情同意过程获得的关于试验的知识与现场实际情况相符，139（97.9%）名受试者表示愿意参加通过在线视频会议进行的知情同意程序。基于视频的知情同意过程取得了与现场知情同意过程相同的效果。前者为受试者节省了时间和交通费用，并且具有良好的公众接受度；特别是在 COVID-19 大流行期间，该过程有助于降低因旅行而导致的受试者感染的风险，还有助于避免现场拥挤。
