Managing Biorisk Linked to Rapidly Expanding SARS-CoV-2 Research.

Abstract

COVID-19 was declared a pandemic by the World Health Organization in March 2020 and is caused by the virus known as SARS-CoV-2. A critical component of global efforts to combat a pandemic is biomedical research. To carry out the research safely, laboratories need to have implemented a wellthought-out biorisk management system (BMS). BMS is a systematic approach to addressing biorisk through hazard identification, risk assessment, risk mitigation, and performance monitoring. This system needs to be already implemented during non-pandemic times so that research related to the outbreak can be managed safely during the pandemic period. Biomedical research, especially on a novel infectious agent, has to be balanced with mitigation measures that are commensurate with the risk. Guidelines for research on SARS-CoV-2 were created early in the outbreak by the US Centers for Disease Control and Prevention and Ministry of Health, Singapore. The guidelines stipulate that virus isolation, virus characterization in cell culture, and the manipulation of infectious virus require biosafety level 3 (BSL-3) containment together with siteand activity-specific risk assessment. The Duke-NUS animal BSL-3 facility is a small annually certified (at BSL-3 containment) 3-lab modular building with about 100 m of functional floor area. The facility has implemented a BMS that includes a multidisciplinary biosafety committee (BC) that oversees all aspects of safety in the facility. There are facility standard operating procedures (SOPs) and risk assessments (RAs) that cover all facility operations. In addition, every time a research team wants to start a project, they need to submit a project application that includes SOPs and RAs for all the research procedures to be undertaken in that project. This application is reviewed by the BC and after approval is implemented in conjunction with the facility SOPs and RAs. Since the COVID-19 outbreak, the BC has seen a 15-fold increase in number of project applications to perform SARSCoV-2-related research. When considering these applications alongside the existing BMS strategy, the following challenges were encountered and addressed: