Impact of COVID-19 on IRB Reviews, Ongoing Research and Protocols

FPU IRB understands that the situation around COVID-19 is rapidly evolving and guidance may be needed for the research community on the continuous protection of human subjects. FPU IRB operations will continue functioning as normal during the current coronavirus disease (COVID-19) outbreak and the City of Fresno “shelter-in-place” order. The IRB Committee will continue to review the numerous protocols received electronically, as well as accept amendments related to changes in research conduct because of the unforeseen circumstances. During the current outbreak, researchers may implement changes to the IRB research, prior to IRB review and approval of the research changes, when necessary to “eliminate apparent immediate hazards to participants.” (see the electronic code of federal regulations, protection of human subjects under 45 CFR 46.108[a][3][iii] and 21 CFR 56.109[a] for details).

FPU IRB has a set of recommendations for faculty, study teams and students, in addressing some issues in IRB protocols in light of the recent pandemic, including how to address: in-person studies/surveys, low enrollment in studies, monitoring changes over time and/or participants, research participants with possible exposure and communicating changes to protocols to IRB. The attachment with IRB recommendations is intended to provide guidance and support for the FPU research community and will be posted at the review board website.