Animal Research and COVID-19: Planning for Recovery and Continuity of Research Programs

A crise CoVID-19 afetou significativamente os programas de pesquisa e uso de animais e cuidados com animais. Na resposta imediata, as instituições foram focadas adequadamente no cuidado dos animais e na segurança do pessoal de cuidados com animais. Muitos foram obrigados a tomar decisões difíceis, resultando em interrupções nas colônias de animais, racionamento de equipamentos de proteção pessoal (EPI) e limites para interações com animais relacionadas à pesquisa. A reconstrução de linhas de animais envolverá dinheiro e tempo - trazer de volta uma linha criopreservada pode exigir vários meses. Alguns estudos de pesquisa precisarão ser reiniciados. Recursos para cuidar de animais podem não estar disponíveis imediatamente. E pode haver limitações na cadeia de suprimentos para substituir o número de animais, especialmente os ratos, que serão obrigados a retomar os estudos de pesquisa. Por exemplo, como muitas instituições restringiram a criação de animais disponíveis comercialmente durante a interrupção, pode haver um atraso na obtenção de algumas cepas comuns disponíveis dos criadores comerciais após a ruptura.

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. O guia para o cuidado e uso de animais de laboratório ( Guia) exige o planejamento de contingência para pessoal e animais em tempos de crise. Após a crise imediata, as instituições devem começar a planejar a estabilização pós-crise e, para alguns, transformação. O roteiro ...

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.

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.

A capacidade efetiva das instalações pode ser limitada por um período prolongado. Os modelos existentes sugerem que o retorno à estabilização após a crise inicial não será um acelerador linear simples, mas um processo de recuperação mais lento com flutuações para acomodar o gerenciamento contínuo do surto CoVID-19. Como parte do exercício do roteiro, as instituições devem começar a identificar quais níveis de pesquisa suas instituições podem apoiar razoavelmente, considerando flexibilidades em capacidade para evitar interrupções futuras excessivas. Por exemplo, uma instituição citou uma estimativa de que a capacidade seria impulsionada principalmente por níveis de pessoal de 60% a 70%, que eram um fator de teste da equipe, a taxa de infecção e o treinamento da equipe projetada para tarefas de criação. Essas transições podem afetar as operações e a capacidade geral da instalação. As instalações reaproveitadas para BSL-2/-3 e a equipe de treinamento em procedimentos exigirão tempo e dinheiro. A substituição de reduções existentes na força de trabalho e limitações dos suprimentos necessários, como o EPI, também pode retardar a recuperação. Esses investimentos podem ser demorados e caros, mas devem ser avaliados para a direção da pesquisa, não apenas na resposta covid-19 em andamento, mas também em preparação para qualquer ameaça futura. Quanto excesso de capacidade deve ser incorporado em modelos de cuidados para permitir flutuações na gestão nacional e local do CoVID-19? As instalações existentes podem ser expandidas ou convertidas com os recursos existentes? A conversão afetará o layout da instalação, por exemplo, tráfego de pedestres, movimento limpo/sujo do equipamento, acesso à instalação e listas de pedidos de entrada da sala?

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.

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

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 Planning de contingência pandêmica para programas de atendimento e uso de animais” para orientar as instituições através da resposta. O site da OLAW inclui perguntas frequentes, conteúdo informativo e links adicionais para instituições. O Departamento de Agricultura dos EUA (USDA) também publicou um conjunto de FAQS. Considerações operacionais. Autor

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.