JMIR Publications

ABSTRACT

Background:

With the global proliferation of the novel coronavirus (COVID-19), conducting Institutional Review Board (IRB) meetings in the conventional manner has become a difficult task. Amid concerns about the suspension of drug development due to delays within the IRB, it has been suggested that IRB meetings be temporarily held online.

Objective:

By conducting a survey on the current state of Web-IRB, this study aimed to elucidate the current status of Web-IRB and highlight related nationwide issues, while presenting the necessary course of action for future Web-IRB Should be defined sessions.

Methods:

A survey on Web-IRB meetings was conducted in Japanese national university hospitals. Respondents were persons in charge of operating the IRB office of each university. The survey yielded a response rate of 74%.

Results:

Due to the COVID-19 pandemic, the overall number of reviews in clinical trial core hospitals has decreased. Additionally, while 68% have introduced Web-IRB, 13% of the surveyed facilities have postponed IRB meetings. According to 71% of the respondents who implemented Web-IRB, the cost of implementation was 0 yen, showing that there is almost no financial burden for its implementation. In 90% of the facilities, Web-IRB meetings were already being conducted using personal electronic devices. Furthermore, in 48% of the facilities, the Web conference system was used in conjunction with face-to-face meetings.

Conclusions:

Due to the COVID-19 pandemic, the number of reviews in clinical trial core hospitals conducting clinical trials has decreased. This suggests that the development of pharmaceuticals has stagnated because of COVID-19. According to 71% of the respondents using Web-IRB, the cost of introducing Web-IRB was 0 yen, showing that there is negligible financial burden regarding implementation. Moreover, it was shown that online deliberations can be carried out in the same manner as face-to-face meetings, as there was no significant change in the number of comments made by the board members. To improve the quality of Web-IRB meetings, it is also necessary to further examine the use of cameras during the meeting and the content displayed on members’ device screens. It became clear that further examination is required on all members who will utilize the Web conference system. The measures addressing the requests and problems identified in this study could potentially be considered as protocols for future IRB meetings when the COVID-19 pandemic has passed and face-to-face meetings become possible again. This study also highlights the importance of developing Web-IRB to respond to future unforeseen pandemics.