Adaptation of Research Infrastructure to Meet the Priorities of Global Public Health

The rise of SARS-CoV-2 has resulted in the urgent need to unlock the mechanisms behind the disease it causes, COVID-19, and to develop countermeasures. As a result, there has been a massive push to study the virus and to test potential candidate vaccines, therapeutics, and antivirals. This has caused a rush at many institutions to switch research priorities to contribute to knowledge about the virus and COVID-19. This means that biosafety professionals have been tasked with figuring out how to conduct research with a novel pathogen safely and securely, often without the requisite knowledge and experience to safely assess the risk. Due to the similarity to another coronavirus, SARS-CoV, many biosafety professionals use the risk mitigation measures for this virus as a starting point. Research with live SARS-CoV-2 requires biosafety level 3 (BSL-3) high containment with additional risk mitigation measures, such as specialized training, engineering controls, personal protective equipment, and health monitoring as well as being mindful of the communication complexities of an ever-connected world. Analyzing human samples, developing diagnostics tests, studying downstream metabolites or proteins, or conducting immunology assays may be performed in a BSL-2 facility with enhanced practices depending upon an institution's risk assessment and risk tolerance. Globally, there are regional differences in high containment laboratories and what is studied in each facility. It is unknown if high-containment laboratory capacity in the United States meets or exceeds the national need or if they can be operated safely (Kingsbury, 2009). In addition, not all BSL-3 facilities are created equal and some do not have the optimal safeguards in place for conducting research with pathogens of pandemic potential. The Government Accountability Office (GAO) previously determined the absence of national standards for high containment laboratory design, construction, commissioning, operations, and maintenance raised concerns and increased the risk of laboratory accidents [US Government Accountability Office (GAO), 2013]. Some BSL-3 laboratories are built for specific purposes and others are built with a limited scope of use. Others are designed in an attempt to anticipate all future uses. More often than not, BSL-3 laboratories are value-engineered due to the high costs of construction, daily-operations, upkeep, and maintenance. Organizations do not want to overspend for features they might not use even though they might need them later on. As a result, there are a limited number of BSL-3 high containment facilities in the United States capable of conducting live SARS-COV-2 research safely and securely, especially with animal models. In addition, not all researchers have the training and expertise to work inside of BSL-3 laboratories. Training programs vary greatly depending on the structure and expertise of the trainer and the previous experiences of researchers. Due to the different designs and resulting standard operating procedures (SOPs), often the training from one facility is not necessarily applicable to another. Although the principles and practices behind biosafety and biosecurity are the same regardless of the design, individuals must demonstrate competency in conducting experiments and the laboratory SOPs before working unescorted. In addition, the COVID-19 pandemic is an ever-evolving situation, and as a result, public health guidance is changing frequently. Currently, there is a greater risk of researchers being exposed to SARS-CoV-2 in the community than from working in the laboratory. In combination, these factors present a challenging environment for biosafety professionals who facilitate research and ensure it is being performed in a safe and secure manner. It takes the entire institutional infrastructure—including but not limited to compliance and safety departments, facilities and maintenance personnel, oversight committees, information technology and security, and media relations—to ensure the research can be brought online swiftly and with limited hindrance in the most effective way possible.