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OVERVIEW OF PERFORMANCE STANDARDS FOR THE HUMANE CARE AND USE OF LABORATORY ANIMALS1
Patricia Turner, Planning Committee Co-Chair, Professor in the Department of Pathobiology and Program Leader of Laboratory Animal Science at the Ontario Veterinary College, University of Guelph, opened the workshop by reviewing how the committee developing the 8th edition of the Guide for the Care and Use of Laboratory Animals approached the topic of performance standards. She emphasized that the Guide, which was published in 2011, was never intended to be an encyclopedia or even a standalone reference. “Rather, it was intended to be a tool integrated with other pieces of information to develop the best care and use practices at any particular facility,” she explained.
The current Guide is the first edition that emphasizes the Three Rs – replacement, reduction, and refinement (Russell and Burch, 1959), the importance of animal well-being in ensuring the integrity of animal-based research, and the responsibility of both the institution and researcher to provide humane care to laboratory animals. As a document, the Guide was meant to be the starting point for institutions to develop guidelines and policies for the comprehensive care of animals used in research. This process would involve collaboration between the institution, the IACUC, as well as technicians, caregivers, and veterinarians who work closely with animals and research groups on a daily basis, while important concepts, such as cost and efficiency, would not be considered in isolation. In addition, said Turner, the Guide was meant to help investigators plan and conduct their studies with scientific rigor.
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1 This section is based on the presentation by Patricia Turner, and the statements are not endorsed or verified by the National Academies of Sciences, Engineering, and Medicine.
The concept of performance standards first appeared in the 7th edition of the Guide, published in 1996. The concept proposed that institutions should have the flexibility to structure their programs to fit their own research needs while providing only minimal guidance as to what such flexibility meant and how institutions should accomplish it. When the update process for the 8th edition began in 2008, researchers had produced a wealth of new information, and acceptable practices for the care and use of laboratory animals had evolved. As a result, the committee that wrote the 8th edition was charged by the statement of task to include performance standards as a central feature. The resulting 220-page document provides examples, references, and information on how to implement performance standards.
Engineering standards in the 8th edition are meant to provide a minimum or a starting point for how to best care for animals, Turner explained. This emphasis, she noted, puts a substantial burden on the research and laboratory animal science communities to develop and implement performance standards in tandem, which is not necessarily easy. “While it provides flexibility to institutions, a performance standard approach requires a mature and experienced outlook to know what might be possible and how it can be achieved. It requires knowledge of systems and procedures in the context of each institutional program, and it may require significant research and consultation,” said Turner. “In addition, it results in a need for careful planning and for critical and ongoing assessment of how the performance standard is working and whether it is truly benefiting the program and the animals.”
Addressing the challenges of developing and implementing performance standards can be frustrating, and after the Guide’s publication, the committee received requests to “just tell me what to do.” Frustrated institutions sometimes default back to engineering standards, said Turner, because it seems easier to do what is prescribed instead of exploring and developing an alternate procedure better suited to the animals, the institution, or the specific research needs.
Turner then defined engineering, performance, and practice standards:
- An engineering standard is a standard or guideline specifying in detail a method, technology or technique for achieving a desired outcome. It does not allow modifications in the event acceptable alternative methods are available, and because of its prescriptive nature it provides limited flexibility for implementation. Engineering standards are helpful for setting a minimum benchmark.
- A performance standard is a standard or guideline describing a desired outcome while providing flexibility in achieving this outcome. When developing a performance standard, it is essential to clearly define the desired outcomes and regularly monitor appropriate performance outcomes to verify the success of the process.
- In the absence of scientific literature or other definitive source, a practice standard is the application of professional judgment to a task or process that over time and experience has been demonstrated to benefit or enhance animal care and well-being.
Performance standards are not exclusive to laboratory animal science, and are often used in other settings such as banking, airline flight tracking, and public safety. Their common feature, said Turner, is that they are not static once developed and implemented. Ideally, engineering and performance standards are balanced, setting a target for optimal practices, management, and operations while encouraging flexibility and judgment. Practice standards, which evolve over time and are widely used and accepted, help define what approaches are and are not acceptable for animal care and use by encompassing a broad base of knowledge, skills, and attitudes. Examples of practice standards in veterinary medicine include collecting temperature, pulse, and respiration during a physical examination; collecting and keeping proper medical records; and collecting informed consent from the owners when enrolling animal patients in clinical trials.
Despite performance standards being at times challenging to develop, there are two good reasons for using them, Turner noted: they provide significant flexibility to institutions to modify and update practices and procedures in response to new information, and they permit timely changes in practice without new regulation or policy. She emphasized that a performance standard both defines expected outcomes and balances the importance of meeting a baseline established by engineering standards with the need for flexibility.
A good performance standard uses what she called “appropriate language,” particularly regarding terms such as must, should, and may that appear frequently in the Guide. “Must,” she explained, indicates actions that the Guide committee considered to be imperative and a mandatory duty or requirement for a facility to follow; “Should” indicates a strong recommendation for achieving a goal, while recognizing individual circumstances might justify an alternative strategy; “May” indicates a suggestion to be considered. It is tempting, said Turner, to
make everything a “must” when developing performance standards, but being reasonable is important. “If something is unlikely to be achieved in every instance, then we are setting the facility up for failure. We need to ask, ‘Is it absolutely essential in every case to have a certain standard in place for ensuring or enhancing animal welfare or safety?” she said. “Should” and “may,” Turner added, can also refer to items that become the norm over time, citing social housing as an example: the Guide refers to social housing as a “should” item, but it has become a “must” in the performance standards written by many institutions.
Performance standards can trigger changes in the standard of practice for laboratory animal care and use as individual institutions monitor, evaluate, and validate the success of a specific approach. Toward this end, Turner stressed the importance of sharing changes in performance standards by presenting them at conferences and publishing them in the peer-reviewed literature. Publication, she added, adds to the credibility of the work, makes it easier for other institutions to justify changing their performance standards, and can illustrate an approach with potential utility in other situations. While this evolution can frustrate researchers and institutional officials who may feel the ground is constantly shifting under their feet, it does reflect new knowledge and expectations and increases the level of care for research animals.
Turner then discussed how the Guide committee developed certain recommendations related to performance standards. Her first example considered temperature. A Guide table lists recommended dry-bulb macroenvironmental temperatures for many species. While it is easy to look at the table for the engineering standard, said Turner, it is important to interpret this information in context with the associated text to get the full meaning of committee’s intentions. For rodents, the Guide further recommends that dry-bulb temperatures in animal rooms should be set below the animals’ lower critical temperature to avoid heat stress, to provide the animals with adequate resources for behavioral thermoregulation (such as nesting materials) and to minimize variations around a set temperature. The Guide also lists circumstances requiring additional considerations, such as when animals are recovering from surgery or when the facility houses neonates or hairless rodents.
She then discussed social housing. All animals, the Guide states, should be housed under conditions that provide sufficient space and supplementary structures and resources required to meet their physical, physiologic, and behavioral needs. Single housing of social species should be the exception and be justified based on experimental requirements or veterinary-related concerns about animal well-being. This performance
standard implies that facilities must have an understanding of species’ typical social behavior, including behaviors such as dominance or aggression. It also means the IACUC and veterinarians need to review rigorously and regularly any proposal which includes single housing.
In response to this performance standard, institutions have had to reexamine their ability to socially house certain species, such as rabbits and male mice of different strains. For example, research has shown that BALB/c mice can be housed in isosexual groups for long periods of time with minimal agonistic behavior, but only if those groups are established by five to six weeks of age and only if housed with sufficient environmental resources. Many institutions, noted Turner, are still trying to decide whether and how laboratory rabbits can be paired and group-housed in research settings. “This is a continuing and evolving process in terms of our knowledge of social housing, but without this performance standard requirement, institutions wouldn’t be forced to look at some of these practices more closely,” said Turner.
Another example of a performance standard focuses on environmental enrichment programs, which the Guide states should be reviewed by the IACUC, researchers, and veterinarians on a regular basis to ensure they benefit animal well-being and are consistent with the experiments performed. According to this performance standard, personnel responsible for animal care and husbandry should receive training in the behavioral biology of the species they work with to appropriately monitor the effects of enrichment and identify the development of adverse or abnormal behaviors. Furthermore, it aims to balance the importance of deploying resources and enrichment strategies with the need to support the scientific goals of the study, and it therefore requires a solid understanding of each particular project, said Turner. This performance standard also implies that enrichment should be considered an independent variable that needs to be suitably controlled for in studies.
Turner noted that the cage and pen space performance standard has generated a great deal of comment and interest by the research community. The Guide states that “at a minimum, animals must have enough space to express their natural postures and postural adjustments without touching enclosure walls or ceiling, be able to turn around, and have ready access to food and water. In addition, there must be sufficient space to comfortably rest away from soiled areas,” and “cage height should take into account the animal’s typical posture and provide adequate clearance for the animal from cage structures, such as feeders and water devices.” Furthermore, “sufficient space should be allocated
for mothers with litters to allow the pups to develop to weaning without detrimental effects for the mother or the litter.” As this performance standard implies, animal space needs are complex, and space allocations need to be assessed, reviewed, and modified as necessary by the IACUC based on performance indices such as health, reproduction, growth, activity, and behavior. For example, the 8th edition provides recommended minimum space needs for rodent females with litters based on current practice standards used by some breeding operations. These are intended to serve as a starting point for addressing the space needs of breeding groups taking into consideration additional parameters such as number of adults, litter size, sanitation frequency, and the age of the pups.
A new performance standard requires validation, and one should never be developed at the expense of animal health and well-being, or in a way that interferes with the science being conducted, said Turner. She added that the principles of the Guide are intended to provide an ethical approach for all animals used in research, including fish and cephalopods. However, since there are over 30,000 fish species it would be impossible to include sufficient detail for each of them.
In her conclusion, Turner emphasized that a well-established performance standard, meets the following criteria:
- It supports scientific objectives,
- It supports the health and welfare of the animals,
- It has outcomes set in advance and associated criteria to assess them, and
- It is regularly monitored for success.
The 8th edition of the Guide relies heavily on developing and implementing appropriate performance standards to enhance the care and well-being of laboratory animals. This approach, said Turner, allows for institutions to be responsive and to implement actions in a timely fashion while requiring rigor and validation to ensure the outcome is as good as or better than the previous performance or engineering standard.
