Remote review practices of Institutional Review Boards during the COVID-19 pandemic in Korea: comparison with a Japanese study

Abstract

The worldwide pandemic of the novel coronavirus disease 2019 (COVID-19) had an immediate impact on acceleration of the introduction of alternative methods of operation for Institutional Review Boards (IRBs) defined in ICH E6 (GCP) guidelines. This study was carried out to compare the operational status of IRBs in Korea during the COVID-19 outbreak with the results of a survey conducted in Japan during the same period. An online survey of IRBs was conducted in Korea from May 5 to July 31, 2020. A self-administered questionnaire about the profiles of IRB organization, impact of the COVID-19 outbreak on IRB operation, and status of using Information and Communication Technology (ICT) tools such as electronic document management systems and digital communication systems was distributed by e-mail to 169 IRBs in Korea. Responses were collected electronically via the online questionnaire survey. The survey results were then analyzed and compared with those from our previous survey in Japan containing the same questionnaire items, which was distributed to 520 IRBs. A total of 43 IRBs in Korea participated in the survey, and the results were compared with those from 97 Japanese IRBs. Although the local IRB has the largest share in both Japan and Korea, the frequency of review meetings and the impact of the COVID-19 outbreak were greater in Korea than in Japan. Both countries used ICT during the COVID-19 outbreak, but Korea was less concerned about ICT use compared to Japan.