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Detailed Steps in The Development of Performance Standards - Mulder
Detailed Steps in The Development of Performance Standards - Mulder
Performance Standards
Todays talk
Performance standards
The Guide
General approach
Goal
Key steps
Key stakeholders
Our philosophy and approach
Standardized process
Proposal, review and analysis, post-approval monitoring
Performance standards
The Guide endorses a performance-based
approach to meeting Guide recommendations
Performance approach requires(Guide, p 6)
Professional input
Sound judgment
Team approach
Clearly defined outcomes and goals
Regular monitoring of performance measures
Goal
A performance approach allows use of alternative
methods to those outlined in the Guide to provide
equivalent or improved conditions for animals
Conditions that do not meet minimal Guide
recommendations should result in deleterious
changes in animal welfare that are measurable
5. Review of results
IACUC: approve, disapprove, or require modifications to the
exception
6. Regular monitoring
Key stakeholders
The IACUC
Attending veterinarian
Researchers
Animal users
Specialists (as needed)
Unique expertise in areas of study design, equipment,
interpretation of results, etc.
Vivarium management
Including husbandry personnel
Standardized form
Consistency and
documentation purposes
Proposed exception
Rationale for the exception
Proposed performance measures
Proposed methods to investigate the exception
Research proposal with hypothesis
Including statistical analysis when applicable
Results reviewed
Variance approved/modified/denied by IACUC
Identify exceptions
Examples
Cage density of mice and rats
Cage change frequency
Multiple rodent species in the
same housing room
Water bottle sanitation
frequency
Species:
Mice and rats
Breeding cages
1 male + 2 females &
litter(s)
Strict interpretation of
space recommendations
problematic
Guide, p 57
Application of variance
Applied only to production
facilities housing mice and
rats
Variance specifies
not apply to animals that are
experimentally manipulated
Guide, p 56
Guide recommendation
Space allocation
Table 3.2 (prior slide)
Space allocation
performance indices
Health
Reproduction
Growth
Behavior
Activity
Space utilization
Special needs
e.g. obesity
Experimental use
Guide p 56
Proposed variance
Continued use of .cage density standards
developed by Charles River based upon many
years of experience with producing rodents at
these densities
Densities modified over the years in response to internal
evaluations and professional judgment
Post-approval monitoring
Utilizing key performance indicators
Performance measures
Categories:
Production indices
Behavioral indices
Clinical measures
Multiple measures
from each
Space allocation
performance indices
Health
Reproduction
Growth
Behavior
Activity
Space utilization
Reproductive performance
Example indices
Production Index (PI)
Pups weaned per female breeder per week
Behavioral assessment
Example Indices
Aggression/Fighting
Maternal aggression
towards pups
Aggression between
weanlings and adults
Scoring systems
For each parameter
Most data collected in
production rooms by
trained husbandry
technicians
Space utilization
required 24-7
videography, difficult to
achieve in a functioning
barrier room.
Behavioral measures
Space utilization
Performed in a behavioral
lab
24-7 video
Light and dark cycle
recording
Spanned the breeding life
(multiple litters) of breeding
groups
Clinical measures
Examples
Mortality
By sex, breeding colony
segment, etc.
Research proposal
Team approach
Veterinarians
Behavioral scientist w/ significant rodent experience
IACUC members
Production management
Husbandry staff
IACUC
Reviewed and approved research protocol
Interpretation of results
Differences will be identified between groups
Must Question: Are they physiologically, metabolically or
behaviorally relevant?
A statically significant difference at some P value (e.g., p
< 0.05) does not mean that there is a problem - may just
reflect adaption.
Adaption can occur without harm to welfare
Failure to adapt or being forced to try to adapt to extremes
without adequate time or resources results in clinical harm.
e.g. Housing room temperatures for rodents are generally
below the thermoneutral zone; social housing, nesting
material, bedding allow adaptation
Interpretation of results
It is unlikely that all findings will be in agreement
between Guide recommendations and
alternatives.
IACUC must consider:
Is there a definable and consistent mechanism that is
clearly linked to detrimental animal welfare?
If so, further evaluation may be warranted
Or, the IACUC can require modifications, restrictions,
or deny the exception.
Animals:
Inbred: C57BL/6, BN
Outbred: CD-1, CD
Breeding conditions:
Mice: female alone,
pair, trio
Rats: female alone, pair
Cage sizes:
Small*
CRL standard
2011 Guide
Huge*
*Unrealistic. Added to
attempt to force a change.
30
Cage sizes
Mice
226 cm2
305 cm2*
432 cm2
800 cm2
Rats
580 cm2
758 cm2*
903 cm2
1355 cm2
32
33
Behavioral measures
1/0 sampling (yes/no) for
Play behavior or popcorning
2 minutes every 30 minutes over a
24 hour period
Additional measures
Reproductive measures
Litter size at birth
Litter size at weaning
Weaning weight
Production Index (PI)
Wean/female/week
Other
Hair loss (pups/adults)
Fighting/wounding
Stereotypies
Settings
Behavioral lab
48 mouse cages
32 rat cages
Barrier room
480 mouse cages
320 rat cages
35
RESULTS (PARTIAL)
Full results to be published soon
By Kate Pritchett-Corning & Brianna Gaskell
36
Preliminary results
Cages can be too small
Excessive soiling in smallest
cages
CD rats breeding in pairs in
the smallest showed a
decrease in reproductive
performance
Reproductive performance
did not decrease with mice
in smallest cage
37
38
Corner inactivity
Review by IACUC
Full results of the
evaluation were presented
to the IACUC
The IACUC approved the
use of CRL cage densities
for breeding mice and rats
Post-approval monitoring
IACUC review of performance indicators
Annual review of the variance for 2 consecutive years
Key performance indicators
Thank you
&
Questions