Research and teaching using animals:
Regulation, ethics, and oversight
• Eric Sandgren, VMD, PhD
– Associate Professor of Pathobiological Sciences
– Chair, All Campus Animal Care and Use Committee
• Holly McEntee, BA, MA
– IACUC Administrator, UW-Madison
The character of public support for use of
animals in biomedical research is highly variable
• How is the polling question asked?
• Who asks the question; who is asked?
• Does the question state whether possible animal
pain or distress is a part of the research?
Education is, sadly, deficient.
Use of animals in research and teaching
is highly regulated
• Animal Welfare Act (AWA)
– USDA Animal Care Policies
• Public Health Service Policy (Office of
Laboratory Animal Welfare, OLAW)
• AAALAC: Association for the Assessment and
Accreditation of Laboratory Animal Care,
International
The Animal Welfare Act
• Passed in 1965 by the US Congress; multiple
amendments
• Enforced by the USDA; failure to follow the law
can result in fines or jail
• Unannounced inspections at least once per year
• Does not cover rats, mice, or birds bred for
research
Animal Welfare Act--significant requirements
• The Institution must have an IACUC (Institutional
Animal Care and Use Committee)
• The Institution must provide for the psychological
well being of non-human primates
• The Institution must provide exercise for dogs
Public Health Service
• Institutions using PHS funds must follow “The
Guide for the Care and Use of Laboratory
Animals” (Guide)
• Covers all vertebrate species
• Failure to follow the Guide can result in loss of
funding to the institution
The Guide defines the requirements of a
Laboratory Animal “Program”
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•
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Program integration
Physical plant
Animal environment, housing, and management
Personnel qualifications and training
Occupational health and safety
Veterinary medical care
IACUC
Institutional official
IACUC
• Must have at least a laboratory animal veterinarian, a
scientist, and a community member not affiliated with the
institution and who does not use animals in research
• Reviews all facilities and programs twice a year; identifies
and ensures correction of any deficiencies
• Reviews “Protocols”, the researcher’s or teacher’s proposal
for animal use
• Monitors animal use; can suspend any animal activity that
does not meet standards
The protocol review
process (simplified)
AAALAC: Association for the Assessment
and Accreditation of Laboratory Animal Care
• Not regulatory, but evaluates the quality of a
program; provides an independent “seal of
approval”
• Graduate (includes Primate Center), Medical, and
Veterinary Schools at UW-Madison are accredited
• CALS and L&S have made the decision to
become accredited
The ethics of animal use
• Utilitarianism: the view that an action is
right if and only if it produces a better
balance of benefits and harms than available
alternative actions
• Consider the “U.S. Government Principles
for the Utilization and Care of Vertebrate
Animals Used in Testing, Research, and
Training”
U.S Government Principles (summary)
• Procedures involving animals should be designed and performed with due
consideration of their relevance to human or animal health, the
advancement of knowledge, or the good of society.
• The animals selected for a procedure should be of an appropriate species
and quality and the minimum number required to obtain valid results.
[Alternative] methods…should be considered.
• Proper use of animals, including the avoidance or minimization of
discomfort, distress, and pain when consistent with sound scientific
practices, is imperative.
• Procedures with animals that may cause more than momentary or slight pain
or distress should be performed with appropriate sedation, analgesia, or
anesthesia.
• Animals that would otherwise suffer severe or chronic pain or distress that
cannot be relieved should be painless killed at the end of the procedure or, if
appropriate, during the procedure.
U.S Government Principles (continued)
• The living conditions of animals should be appropriate for their species and
contribute to their health and comfort….veterinary care shall be provided as
indicated.
• Investigators and other personnel shall be appropriately qualified and
experienced for conducting procedures on living animals.
• …exceptions…should be made by…an appropriate review group such as an
IACUC
Utilitarianism!
Stewardship
The three “R’s”:
a consensus in the research community
• Reduce
• Refine
• Replace
IACUC Protocol Review
• Does the research address an important question?
• Does the research require the use of animals?
• Is the research necessary, in that it does not
needlessly repeat previous work?
• Is the experience of each animal in the study
adequately described and justified?
Back to Utilitarianism:
Animal researchers and PETA have the same
ethical underpinnings. Go figure.
What are animals used for?
• Rowan 1968 (accurate numbers are hard to find)
–
–
–
–
Teaching………………………………8%
Research……………………………..40%
Toxicology…………………………..20%
Drug development……………………6%
How many animals are used each year?
• AWA regulated animals
– 1-2 million per year
– Does not include mice, rats, or many birds bred for
research
• Trends from the 1970s to the 1990s
– Reduction in dogs: 200,000 down to 100,000
– Reduction in cats: 75,000 down to 40,000
– Primate number stable at about 50,000
UW-Madison: animals used
Dogs
1991
1298
1996
606
2000
669
2005
673
Cats
438
173
258
138
G. Pigs
1330
964
23
2
Hamsters 6265
5333
2206
1062
Rabbits
2428
1598
658
129
Primates
2096
2306
2441
1990
UW-Madison (Oct 2004 - Sept 2005)
#bred/held
No pain
Treated pain
Dogs
15
155
518
Cats
3
80
58
G. Pigs
0
2
0
Hamsters 0
863
199
Rabbits
7
21
108
Primates
670
1363
627
Opponents of animal in research
• It is unethical to use animals regardless of the benefits
(animal rights perspective)
• Most human health advances have come from improved
sanitation
• Research animals live impoverished lives, filled with fear
and pain
• Stressed animals are poor models
• Most of the research can be done using alternative methods
Proponents of animal research
• We cannot do this research on humans; utilitarianism can
guide our use of animals in a way that is ethical
• Dramatic improvements in both human and animal health
have been made possible by animal research
• Research animals are well cared for, and if used properly
provide good models of human and animal biology and
disease
• There are no alternatives that can replicate the complexity
of a living organism
Environmental Enrichment
• Non-human primate enrichment; also AV, cage mates
• Rodent enrichment: nestlets, structures, cage mates
Case study: Harry Harlow
• Harry Harlow, 1905-1981. Deborah Blum wrote about
Harlow in her 2002 book “Love at Goon Park”
• Background: The discovery of disease transmission had led
to a belief in a sterile, isolated environment as the IDEAL
environment for raising infants.
• During the early 1900s:
– Workers at orphanages avoided contact with children as
much as possible
– Mothers were instructed not to kiss or cuddle their
infants
– Behaviorist Watson wrote “obvious affection always
produced ‘invalidism’ in a child.”
Harlow, continued
• Harlow was attempting to prove that touch,
affection, and “a mother’s love’ all are important
and valid aspects of biology and human
relationships.
• His studies profoundly changed the way children
were raised
• Experiments employing his methods would not be
approved today
Pig Taser Study
• Importance of the issue: People are dying from
the supposedly non-lethal taser; how can this
alternative to bullets be made safer?
• Need for animals: The study purpose is to map
the flow of electricity through a body, and
specifically through the heart; this can only be
modeled in a living organism. Pigs have a
cardiovascular system that resembles that of
humans.
Pig Taser Study (continued)
• Lack of alternatives: Human volunteers cannot be
implanted surgically with recording electrodes, and
shocked to look for ventricular fibrillation; cadavers
provide no physiological information
• Animal experience: Pigs are anesthetized throughout
the entire procedure (anesthesia was designed by
human and veterinary anesthesiologists), and they are
euthanized before waking; therefore, they can have
no sensation of pain
The future at UW-Madison
• Currently there are major organizational changes;
we recently have conducted the first campus-wide
program review in addition to the existing unitspecific reviews
• Ensuring compliance on campus: FIFIs
• 3 R’s
• Continue to communicate with the public about
the use of animals in research and teaching
Thank you for caring;
thanks to the animals