Animal Research and COVID-19: Planning for Recovery and Continuity of Research Programs
The COVID-19 crisis has significantly impacted animal subjects research and animal care and use programs. In the immediate response, institutions have been appropriately focused on the care of animals and the safety of animal care personnel. Many have been required to make difficult decisions resulting in disruptions to animal colonies, rationing of personal protective equipment (PPE) and limits to research-related animal interactions.
The road to recovery for research will be long and may require similarly difficult decisions. Rebuilding animal lines will involve money and time — bringing back a cryopreserved line could require several months. Some research studies will need to be restarted. Resources to care for animals may not be immediately available. And there could be limitations in the supply chain to replace the number of animals, especially mice, that will be required to resume research studies. For instance, since many institutions have restricted breeding of commercially available animals during the disruption, there may be a delay in obtaining some common strains available from the commercial breeders upon ramp-up.
The focus on the health and well-being of animals and personnel is paramount. The Guide for the Care and Use of Laboratory Animals (Guide) mandates contingency planning for personnel and animals in times of crisis. Following the immediate crisis, institutions should start planning for post-crisis stabilization and, for some, transformation.
Develop a road map to understand needs and capacity in the upcoming year
Institutions should develop a flexible road map in the near term to guide supporting the resumption of research as operations recover from the initial crisis period. The road map would ideally be a fluid document that is a companion and extension to existing crisis response plans. It will need to be responsive to a number of factors, including those out of the control of the institution, such as federal, state and local directives. Institutions should start by understanding and incorporating factors that can be planned and managed.
Development of a road map should consider needs by individual research lab and the institutional capacity to accommodate recovery. By addressing these needs now, institutions can begin to communicate funding requirements, ready necessary facilities and prioritize the future allocation of resources. Additionally, these discussions may help researchers begin to seek recovery for financial losses.
The Office of Laboratory Animal Welfare (OLAW) has noted that institutions have financial recovery options. Institutions may place research animals from expired or shutdown projects on holding protocols and recover per diem costs on National Institutes of Health (NIH) awards. Alternatively, institutions may contact the NIH awarding institute for administrative supplements for unanticipated costs resulting from the COVID-19 crisis, though the level of funding that will be available for this is not yet clear.
Plan needs at a detailed level
Institutions should communicate with individual research labs to understand their resource, compliance and financial needs in the upcoming months and as research ramps back up. One institution in a heavily COVID-19-impacted area further described its process for engaging individual researchers as an ongoing outreach process. At that institution, animal operations leadership met with each lab at the outset of the disruption to obtain justifications for their current studies and to identify future studies that would move forward. Deans and the vice president of research then identified a small number of studies that could be completed. The institution plans to repeat a similar process during the ramp-up period.
By understanding needs at a more granular level, institutions can more accurately determine the larger picture for research demand and also identify where flexibilities may exist to enable growth at a more deliberate pace.
Institutions should understand what capacity will represent “the new normal” after initial recovery, levels of readiness and the timeframe to achieve these goals.
Effective capacity of facilities may be limited for an extended period. Existing models suggest that the return to stabilization after the initial crisis will not be a simple, linear ramp-up, but rather a slower recovery process with fluctuations to accommodate ongoing management of the COVID-19 outbreak. As part of the road map exercise, institutions should begin to identify what levels of research their institutions can reasonably support, while considering flexibilities in capacity to avoid excessive future disruptions. For instance, one institution cited an estimate that capacity would be driven primarily by 60%-70% staffing levels, which were a factor of staff testing, projected staff rate of infection and training for husbandry tasks.
Facilities may also need to transform to accommodate increases in COVID-19 research in the upcoming months. These transitions could impact operations and the overall capacity of the facility.
Last, institutions will need to determine how quickly recovery can reasonably occur. Repurposing facilities for BSL-2/-3 and training staff on procedures will require time and money. Replacing existing reductions in workforce and limitations on necessary supplies, such as PPE, could also slow recovery. These investments may be time-consuming and costly, but should be evaluated for research direction, not only in the ongoing COVID-19 response but also in preparation for any future threats.
Create a plan for allocation
Building a road map will assist with allocating resources and minimizing disruption as institutions move toward recovery. However, executing this plan will require policy decisions, institutional oversight and new resource allocation processes.
Operationalize the recovery process
Determine which research will receive the highest priority for access to limited resources, establish institutional guidance and communicate.
Organizational prioritization will vary, but should consider the following factors:
Develop a dedicated research review committee to evaluate scientific merit of studies for access to limited resources.
Decisions related to resource allocation and research prioritization are complex and cannot be fully addressed at the operational level. A cross-functional committee of researchers, administrators and leadership would provide the necessary perspective and the authority to best make these difficult decisions.
Animal facilities should also institute measures to control resource allocation as needed.
Implementing the road map
Addressing these questions should be a first step for institutions as they continue to navigate the changing COVID-19 environment. The answers to the framework presented above will vary by institution, depending on the degree of disruption to date, focus of research going forward and capacity of facilities. In addition to these internal factors, institutions will also need to monitor and incorporate external factors, including state, local and federal directives. Regardless of these many factors, institutions should develop a road map now and begin to identify and build the mechanisms needed to execute the plan in the upcoming months.
The response to COVID-19 is constantly evolving, which means that new challenges will likely arise, as will new guidance. Fortunately, the federal government has been actively publishing guidance to allow institutions to stay informed. The Office of Laboratory Animal Welfare (OLAW) recently published “COVID-19 Pandemic Contingency Planning for Animal Care and Use Programs” to guide institutions through the response. The OLAW site includes FAQs, informational content and additional links for institutions. The U.S. Department of Agriculture (USDA) also published a set of FAQs.
Huron will continue to provide guidance as institutions work through the COVID-19 crisis, including companion guidance for human subjects research, which discusses similar topics for evaluation of scientific merit and other operational considerations.
Please see Huron’s COVID-19 resource webpage for additional content and upcoming guidance in the upcoming weeks and months.