Transcript Institutional Animal Care and Use Committee (IACUC)

Office for the
Responsible Conduct of Research
Use of live, vertebrate
animal subjects in research
B. Helen Jost, PhD
IACUC Director
IACUC Co-Chair
Historical use of research animals

Research animals have been used as human
surrogates for well over a century
 Without regulation
 Often without concern for animal welfare

During that time, there were a number of
animal cruelty laws in several states across
the country
 However, there were no laws that specifically
addressed the procurement and use of animals in
research
Genesis of animal research regulation

Several affiliated research groups formulated
and used standards of care for rodents
 Standardized conditions were important to
experimental reproducibility
 Animal welfare was also considered (3 R’s)

Dognapping of “strays” to sell to research labs
was a reality
 In 1965, a story in Time about Pepper the
Dalmatian sparked a strong desire across the
country to halt this practice
The Animal Welfare Act

The Animal Welfare Act (AWA) was
enacted in 1966
 Only included dogs and cats
The AWA covers animals used in commerce,
exhibition, teaching, testing, and research
 The AWA excludes:

 Cold-blooded animals (reptiles, fish, frogs)
 Animals used for agriculture (cattle, pigs, sheep, goats,
horses, llamas)
 Mice, rats and birds purposely bred for use in research
■
90% animal research uses lab mice and rats
AWA oversight
Unannounced inspections by a USDA
Veterinary Medical Officer (VMO)
 The VMO is charged with identifying
non-compliance with the AWA and its regulations

 Visits facilities, inspects animals, reviews records

Non-compliant items (NCIs) are published on-line
and may incur fines
 Identification and correction prior to inspection is
not cited as an NCI
Public Health Service Assurance

Institutions receiving PHS funds for animal
research must assure that research will be
conducted as described in the PHS Policy on
the Humane Care and Use of Laboratory
Animals
 Must follow all applicable laws
 Must follow the Guide to the Care and Use of
Laboratory Animals

The Assurance is renewed every 5 years, with
reports submitted annually
 Without this Assurance there is no NIH/NCI funding
for research involving animals
OLAW oversight
The Office of Lab Animal Welfare
monitors compliance with the PHS Policy
 OLAW uses a mechanism of self-policing and
self-reporting

 The institution identifies non-compliance and reports to
OLAW with corrective actions

There are no unannounced inspections
 However, audits can occur, usually for cause

Serious and uncorrected violations can result in
the loss of PHS funding
 To individuals
 To the institution as a whole
AAALAC accreditation
 Association
for the Assessment and
Accreditation of Laboratory Animal Care
 AAALAC is a voluntary organization that makes
recommendations based on results of site visits
 Standards are continually updated to reflect
current knowledge in laboratory animal science
 OLAW
accepts AAALAC accreditation
in lieu of additional OLAW oversight
Regulatory authority at UA

The University of Arizona is:
 Registered with the USDA as a research institution
 PHS assured
 AAALAC accredited

The Institutional Official (IO) has ultimate
responsibility for the animal care and use
program
 Vice President for Research

The Institutional Animal Care and Use
Committee (IACUC) administers the animal
care and use program
The IACUC

IACUC membership must include:
 Scientists
 Veterinarians
 Non-scientists
 Non-affiliated “community” members

Due to the diversity of the Committee, the
rationale for the use of animals must be
written in easy to understand language
 The “lay” description

Unlike humans, animals can’t consent
 The IACUC acts as their voice
IACUC responsibilities

Oversees the Animal Care and Use Program
 Make recommendations to the IO for improvements

Inspects animal housing and research labs
 Semi-annual inspections

Ensures protocol participants have training
 To understand the laws and ethics of animal research
 To conduct specific animal activities
 To understand occupational health issues

Reviews and approves animal research and
teaching
 Protocols and amendments
IACUC review of animal studies
 IACUC
review and approval is required for
all activities involving warm and cold
blooded vertebrate animals, including:
 Research
 Teaching
 Agriculture or field studies
 Use of UA-funded animals at other institutions
 Approval
must be obtained before the
work begins
Description of animal activities
A brief description of the aim/purpose
 A narrative description of all animal activities, in
the order they will occur
 Identification of the scientific endpoints

 The point at which the experimental aims are met

Identification of humane endpoints
 The point at which animals must be removed from the
study, even if the experimental aims are not met

Identification of pain and distress
 Clinical signs
 How will pain/distress be alleviated?
 Why can’t pain/distress be alleviated?
Modifications to approved activities
 Any
changes in your research with animals
must be approved before the work starts
 Additional animals or species
 Addition of new strains or breeding
 New or modified procedures or time points
 Additional of surgery
 Additional drugs/compounds
 Changes in dosages/administration route
 Changes in euthanasia methods
The ethical balance
Scientific
value
Ethical
cost
 To humans
 Pain
 To animals
 Distress
 To science
 Morbidity
 To society
 Mortality
The 3 R’s (Russell and Birch, 1959)
3 R’s are one tool that the IACUC uses
to balance the scales
 The
 Can we replace the use of animals with
non-
animal models or lower species?
 Can we reduce the number of animals used and
still achieve statistically significant data?
 Can we refine the procedures to minimize or
eliminate pain and distress?
Do animals need to be used?

Does the benefit outweigh the harm to the animal?
 The data can be translated into future human or animal
clinical studies
■
Development of drugs or therapies
 When there are clear benefits to society and the
advancement of knowledge
■

Species ecology and conservation
Can a non-animal model be used?
 In vitro assays, tissue culture
 Computer models, simulations
 Manikins, especially for training
Does the species need to be used?

Hierarchy of species
 Non-human primates
 Farm animals (cattle, pigs, sheep)
 Rabbits, ferrets
USDA
regulated
 Companion animals (dogs, cats)
 Guinea pigs, hamsters, gerbils
 Lab rats
 Lab mice
 Fish, frogs
 Invertebrates

Ag and field studies do not follow this paradigm
 Not animal models
Are the fewest animals used?

The number of animals requested must be
justified

The number of animals per experimental
group should be consistent with generation
of scientifically sound data
 Justification
can include use of:
 A statistical method to ensure a p value
 Previously documented experience (PI or
literature)
The most important R – refine?
Review current scientific literature to identify
modified techniques that reduce pain or distress
 Use appropriate sedation, analgesia and/or
anesthesia for painful or distressful procedures
 Limit the number of procedures experienced by
any individual animal
 Ensure adequate post-procedural care



Know the signs of pain and distress
Identify appropriate scientific and humane
endpoints

Remove animals from the study based on humane
endpoints to minimize pain and suffering
The ethics of animal research

Animal research is affected by the same ethical
issues as other kinds of research
 Data fabrication or falsification; researcher bias;
conflict of interest; intellectual property issues;
misuse of funds

However, there is also protocol non-compliance,
that is performing animal activities that have not
been reviewed and approved by the IACUC
 Non-compliance may be reportable to the USDA or
OLAW

It is critical that everyone know what is approved
 Submit amendments to modify animal activities before
starting the work
The ethics of animal research

As scientists, we should be aware of the impact
that animal research has on our accumulated
knowledge
 Much of what we know about the biological sciences
had its start with animal research
 Most human studies being conducted today rely directly
or indirectly on data from animal studies

However, animal research should only be
undertaken
 After careful consideration of the scientific value
obtained as compared to the ethical cost of using
animals
 With the utmost concern for animal welfare
IACUC Contacts
Sean Limesand, PhD, IACUC Chair
Phone: 626-8903
Email: [email protected]
 David Besselsen, DVM, PhD, Attending Veterinarian
Phone: 626-1066 or 621-1564
Email: [email protected]
 Helen Jost, PhD, IACUC Director and IACUC co-Chair
Phone: 626-5304
Email: [email protected]

Or email: [email protected]
Resources

USDA Animal Welfare Act
 http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/an
imalwelfare?1dmy&urile=wcm%3apath%3a%2Faphis_
content_library%2Fsa_our_focus%2Fsa_animal_welfar
e%2Fsa_awa%2Fct_awa_program_information

PHS Policy
 http://grants.nih.gov/grants/olaw/references/phspol.htm

The Guide
 http://grants.nih.gov/grants/olaw/Guide-for-the-Care-
and-Use-of-Laboratory-Animals.pdf

IACUC home page
 http://orcr.arizona.edu/iacuc