Yagi Kenta, Maeda Kazuki, Sakaguchi Satoshi, Chuma Masayuki, Sato Yasutaka, Kane Chikako, Akaishi Akiyo, Ishizawa Keisuke, Yanagawa Hiroaki
Clinical Research Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan.
Department of Clinical Pharmacology and Therapeutics, Tokushima University Graduate School of Biomedical Sciences, Kuramoto-cho, Tokushima, Japan.
J Med Internet Res. 2020 Nov 19;22(11):e22302. doi: 10.2196/22302.
With the global proliferation of the novel COVID-19 disease, conventionally conducting institutional review board (IRB) meetings has become a difficult task. Amid concerns about the suspension of drug development due to delays within IRBs, it has been suggested that IRB meetings should be temporarily conducted via the internet.
This study aimed to elucidate the current status of IRB meetings conducted through web conference systems.
A survey on conducting IRB meetings through web conference systems was administered to Japanese national university hospitals. Respondents were in charge of operating IRB offices at different universities. This study was not a randomized controlled trial.
The survey was performed at 42 facilities between the end of May and early June, 2020, immediately after the state of emergency was lifted in Japan. The survey yielded a response rate of 74% (31/42). Additionally, while 68% (21/31) of facilities introduced web conference systems for IRB meetings, 13% (4/31) of the surveyed facilities postponed IRB meetings. Therefore, we conducted a further survey of 21 facilities that implemented web conference systems for IRB meetings. According to 71% (15/21) of the respondents, there was no financial burden for implementing these systems, as they were free of charge. In 90% (19/21) of the facilities, IRB meetings through web conference systems were already being conducted with personal electronic devices. Furthermore, in 48% (10/21) of facilities, a web conference system was used in conjunction with face-to-face meetings.
Due to the COVID-19 pandemic, the number of reviews in clinical trial core hospitals has decreased. This suggests that the development of pharmaceuticals has stagnated because of COVID-19. According to 71% (15/21) of the respondents who conducted IRB meetings through web conference systems, the cost of introducing such meetings was US $0, showing a negligible financial burden. Moreover, it was shown that online deliberations could be carried out in the same manner as face-to-face meetings, as 86% (18/21) of facilities stated that the number of comments made by board members did not change. To improve the quality of IRB meetings conducted through web conference systems, it is necessary to further examine camera use and the content displayed on members' screens during meetings. Further examination of all members who use web conference systems is required. Our measures for addressing the requests and problems identified in our study could potentially be considered protocols for future IRB meetings, when the COVID-19 pandemic has passed and face-to-face meetings are possible again. This study also highlights the importance of developing web conference systems for IRB meetings to respond to future unforeseen pandemics.
随着新型冠状病毒肺炎（COVID-19）在全球范围内的传播，传统方式召开机构审查委员会（IRB）会议已成为一项艰巨任务。鉴于担心因IRB内部延误而导致药物研发暂停，有人建议IRB会议应通过互联网临时召开。
本研究旨在阐明通过网络会议系统召开的IRB会议的现状。
对日本国立大学医院进行了一项关于通过网络会议系统召开IRB会议的调查。受访者负责不同大学IRB办公室的运营。本研究并非随机对照试验。
该调查于2020年5月底至6月初在42家机构进行，当时日本刚刚解除紧急状态。调查的回复率为74%（31/42）。此外，68%（21/31）的机构引入了用于IRB会议的网络会议系统，13%（4/31）的受访机构推迟了IRB会议。因此，我们对21家为IRB会议实施网络会议系统的机构进行了进一步调查。据71%（15/21）的受访者称，实施这些系统没有经济负担，因为它们是免费的。在90%（19/21）的机构中，已经通过个人电子设备进行了通过网络会议系统召开的IRB会议。此外，48%（10/21）的机构将网络会议系统与面对面会议结合使用。
由于COVID-19大流行，临床试验核心医院的审查数量有所减少。这表明COVID-19导致了药物研发的停滞。据71%（15/21）通过网络会议系统召开IRB会议的受访者称，引入此类会议的成本为0美元，经济负担可忽略不计。此外，86%（18/21）的机构表示委员会成员的评论数量没有变化，这表明在线审议可以与面对面会议以相同方式进行。为提高通过网络会议系统召开的IRB会议的质量，有必要进一步研究会议期间摄像头的使用以及成员屏幕上显示的内容。需要对所有使用网络会议系统的成员进行进一步审查。当COVID-19大流行过去且再次可以召开面对面会议时，我们针对本研究中确定的请求和问题所采取的措施可能会被视为未来IRB会议的规程。本研究还强调了开发用于IRB会议的网络会议系统以应对未来不可预见的大流行的重要性。
