Performance Standards for the Humane Care and Use of Animals in Research

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1 Performance Standards for the Humane Care and Use of Animals in Research ILAR Roundtable Washington, D.C. PV Turner, MS, DVM, DVSc, DACLAM, DABT, DECAWBM Professor and Program Leader, LAS Dept of Pathobiology, University of Guelph Guelph, Canada

2 The Guide as a Tool Sets a tone for overall approach to consideration of the use of animals in research Assist institutions in caring for animals used in research Assist investigators in planning and conducting studies Foundation for comprehensive animal care and use program

3 7 th Edition of The Guide Formal introduction of the concept of Performance Standards Gave institutions the flexibility to structure programs to fit research needs Minimal guidance on what that meant and how to accomplish it

4 8 th Edition of The Guide Update process began in 2008 New technologies Many new publications Changes in the standards of practice Evolution of concept of Performance Standards Statement of Task: Performance Standards should remain a central feature of the recommendations Public Comments: Overwhelming support for the performance standards approach The Result: More information, references, and examples of how to implement Performance Standards

5 Be careful what you wish for Implementing performance standards is not an easy process Requires knowledge of systems and procedures in the context of each institutional program May require research and consultation Careful planning and critical, ongoing assessment

6 Engineering Standard A standard or guideline that specifies in detail a method, technology or technique for achieving a desired outcome Does not provide for modification in the event that acceptable alternative methods are available Prescriptive and provides limited flexibility for implementation Helpful for setting a minimum standard

7 Performance Standard A standard or guideline that, while describing a desired outcome, provides flexibility in achieving this outcome It is essential that the desired outcomes be clearly defined and appropriate performance measures be regularly monitored to verify the success of the process

8 Engineering vs Performance Standards Ideally, engineering and performance standards are balanced, setting a target for optimal practices, management and operations, while encouraging flexibility and judgment, if appropriate, based on individual situations. The Guide, pg 7

9 Practice Standards The application of professional judgment to a task or process over time, which has been demonstrated to benefit or enhance animal care and use. Used in the absence of scientific literature or other definitive source, where experience demonstrates a particular practice to be beneficial to animal care and well-being

10 Why Use Performance Standards? Provides significant flexibility to institutions to modify and update practices and procedures as new information becomes available (responsiveness) Permits change in practices without legislative changes (timeliness) Intention was to make the Guide, 8 th Ed a living document

11 Evolution of Performance Standards Information in peer-reviewed literature Time-proven experience in the field Modification of practices and procedures with changing conditions and new information May lead to modification of existing or development of new performance standards over time

12 Define outcomes Balance of standards Flexibility Recognizing a Good Performance Standard Identifies that there are many ways to achieve defined goals Uses appropriate language (interpreting Must, Should, and May )

13 Use of Must, Should, and May Must - must indicates actions that the Committee consider to be imperative and are a mandatory duty or requirement Should - should indicates a strong recommendation for achieving a goal, however, the Committee recognized that individual circumstances might justify an alternative strategy May may indicates a suggestion to be considered

14 Practice Standards or Developing Standards of Practice? Evolve over time Begin locally (at one institution) Implement performance standards for a specific situation Monitor, evaluate, and validate the success of the approach SHARE > present/**publish** May not fit all situations, but may illustrate an approach useful for other institutions

15 Examples of Performance Standard Approaches Temperature Social housing Environmental enrichment Cage/Pen space

16 Temperature Macro-environmental temperature Table 3.1 (e.g., Rodents C) Generally reflect tolerable limits. provided animals are housed with adequate resources for behavioral thermoregulation Should normally be selected and maintained with minimal fluctuation near the middle of the ranges

17 Temperature (cont d) The ambient temperature in which thermoregulation occurs without the need to increase metabolic heat production or activate evaporative heat loss mechanisms is called the thermoneutral zone (TMZ) and is bounded by the lower and upper critical temperatures (LCTs and UCTs; Gordon 2005). In general, dry bulb temperatures in animal rooms should be set below the animal s LCT to avoid heat stress. This, in turn, means that animals should be provided with adequate resources for thermoregulation (nesting material, shelter) to avoid cold stress. TNZ for mice is C, LCT is 26 C

18 Temperature (cont d) Implications: When animal room temperatures are set lower, as recommended in the table, sufficient nesting material should be provided Variation around a set temperature should be minimized

19 Social Housing All animals should be housed under conditions that provide sufficient space as well as supplementary structures and resources required to meet physical, physiologic, and behavioral needs. Single housing of social species should be the exception and should be justified based on experimental requirements or veterinary-related concerns regarding animal well-being. Social animals should be housed in pairs or groups of compatible individuals unless they must be housed alone for experimental reasons or because of social incompatibility.

20 Social Housing (cont d) Implications: Requires understanding of species-typical social behavior Cage complexities and resources provided such that they cannot be monopolized by dominant animals or elicit aggression between animals The need for single housing should be reviewed on a regular basis and approved by the IACUC and/or veterinarian

21 Environmental Enrichment Enrichment programs should be reviewed by the IACUC, researchers and veterinarian on a regular basis to ensure that they are beneficial to animal well-being and consistent with the goals of animal use. 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, as well as identify the development of adverse or abnormal behaviors.

22 Environmental Enrichment (cont d) Implications: Enrichment strategies should take into account the scientific goals of the study Enrichment should be considered an independent variable and suitably controlled Training - Personnel responsible for daily care should be familiar with normal animal behavior such that abnormal behavior may be recognized and reported

23 Cage and Pen Space 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. 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. 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.

24 Implications Space Recommendations (cont d) An animal s space needs are complex Tables contain recommended minimums Consideration of only the animal s body weight or surface area may be inadequate Considerations for determining space needs Age and sex of animals Number and duration of housing Intended use Special needs

25 Implications Space Recommendations (cont d) Space allocations should be assessed, reviewed, and modified as necessary by the IACUC considering the performance indices such as: health, reproduction, growth, behavior, age, activity, and use of space..and special needs determined by the characteristics of the animal strain or species and use

26 Rodent Breeder Cages Previous editions of the Guide lacked guidance Recommended space for female + litter reflected current standard of practice in some breeding operations using commercially available high density housing racks Intended to be a starting point for addressing space needs of breeding groups

27 Rodent Breeder Cages (cont d) Comment in the Table states that, Other breeding configurations may require more space and will depend on considerations such as number of adults and litters, and size and age of litters. That is other breeding configurations (pairs, trios, etc.) may require more space than the recommended minimum for a female + litter

28 As new information becomes available that challenges existing approaches When conditions arise that are not adequately covered in The Guide When insufficient guidance exists on a particular subject When are New Performance Standards Needed?

29 Developing Performance Standards A well-established performance standard meets the following criteria: Supports scientific objectives; Supports the health and welfare of the animal(s); Has associated outcome criteria; and Is regularly monitored for success Guide, pg 6

30 Summary The Guide, 8 th Ed is heavily reliant on development and implementation of appropriate Performance Standards to enhance research animal care and well-being This approach allows for responsiveness and timeliness as new knowledge appears Still requires rigor and validation to ensure outcome is as good or better than previous Performance Standards

31 Thank-you!