Abstract

BackgroundWith 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.ObjectiveThis study aimed to elucidate the current status of IRB meetings conducted through web conference systems.MethodsA 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.ResultsThe 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.ConclusionsDue 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.

Highlights

  • In 2020, the novel COVID-19 disease became a pandemic [1], causing several changes to people’s lifestyles [2]

  • To improve the quality of institutional review board (IRB) meetings conducted through web conference systems, it is necessary to further examine camera use and the content displayed on members’ screens during meetings

  • We carried out a questionnaire survey among national university hospitals in the country after the official notice to understand the problems concerning IRB meetings conducted through web conference systems

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Summary

Introduction

In 2020, the novel COVID-19 disease became a pandemic [1], causing several changes to people’s lifestyles [2]. Japanese ordinances indicate that IRBs should operate in all medical research institutes [5] Within this context, the Ministry of Health, Labor, and Welfare [6] issued a notice titled “On handling of reviews by the Institutional Review Board regarding clinical trials related to the novel coronavirus,” which advised that IRB meetings were allowed to be conducted via the internet. Due to the declaration of a state of emergency and university regulations, it has become difficult to conduct face-to-face IRB meetings in a group setting at Tokushima University hospital. 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

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