Institutional Animal Care and Use Committee (IACUC) General Information

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Institutional Animal Care and Use Committee
(IACUC)General Information
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UMCES IACUC Members

• Christopher L. Rowe, Chesapeake Biological
  Laboratory, Chair and Scientist Member
• John L. Hoogland, Appalachian Laboratory,
  Scientist Member
• Elizabeth North, Horn Point Laboratory,
  Scientist Member
• Erica Kropp, Center Administration,
  Non-scientist Member
• Kirk Mantay, South River Federation, Community
  Representative
• Janet E. Whaley, USDA/APHIS, Veterinarian

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General InformationI. Ethics of Animal Use in
ResearchThe use of animals in scientific
research is a controversial issue. Animals have
been used throughout history for anatomical and
physiological research as well as for testing
toxic substances. Many medical advances,
including vaccines for polio and rabies, the
development of certain antibiotics and cancer
treating agents and transplant medicine, have
been developed thanks to the use of animals in
research. But the question arises as to whether
it is right or wrong to use animals for these
purposes.
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18th century Utilitarian philosophers believed
that pain and suffering should be minimized and
that animals deserved moral protection. Great
Britain was a leader in the animal welfare
movement and founded the Society for Prevention
of Cruelty to Animals in 1824. The Cruelty to
Animals Act was passed in Great Britain in 1876
and regulated animal experimentation.
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There are, however, other views of the moral
value (or status) of animals that influence the
question of if and how animals are used in
research.Animal rights theorists equate the
lives of animals (or some animals more than
others) with those of human beings and believe
that humans do not have the right to use animals
solely as a means to a human end. Others have
taken political and social action to draw
attention to their views.
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Those who espouse an animal welfare point of
view, however, may believe that while humans and
animals are not necessarily morally equivalent,
animals do have a 'right' not to suffer
needlessly.
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Even those who do not believe that animals have
any moral standing in relation to humans may
believe that it is harmful for a human being to
inflict needless pain and distress on a sentient
being. And from a scientific point of view,
pain and distress can add an uncontrollable
variable into an experiment and so it is in the
interest of good science to control pain and
distress whenever possible.
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A research institution that receives money and
support from the public is responsible for
conducting research according to the limits set
by society. In this instance, the use of animals
in research is a privilege and not a right. The
consensus at this time in the United States is
that animals should be treated humanely and that
pain and distress should be minimized when
animals are used for research or teaching
purposes. This is evident in the laws and
regulations that have been developed by
democratic processes.
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Laws and Regulationsi. Animal Welfare Act
(AWA)In the 1960's, there was public concern
over the conditions experienced by research
animals and fears of pet animals being stolen and
sold into research. These concerns led to the
passage of the Animal Welfare Act (AWA) in 1966.
This act licenses dealers, exhibitors and
breeders of animals, regulates research
facilities that use animals, lists standards for
the humane care and treatment of animals and
regulates the transportation of animals. The Act
was amended in 1970, 1976, 1985, and
1990.http//www.nal.usda.gov/awic/legislat/usdal
eg1.htm
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The AWA specifically exempts birds, mice and rats
used in research as well as agricultural animals
that are used for agricultural production. The
Act also exempts horses that are not used for
research purposes. The protection for these
animals is covered by other regulations and
inclusion under the AWA was considered to be
redundant. The United States Department of
Agriculture (USDA) is the government agency that
is responsible for the enforcement of this act.
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Public Health Service (PHS) PolicyThe Public
Health Service Policy on the Humane Care and Use
of Laboratory Animals is based on the 9 United
States Government Principles for the Utilization
and Care of Vertebrate Animals Used in Testing,
Research and Training. http//grants.nih.gov/gran
ts/olaw/references/phspol.htmUSGovPrinciples
This policy covers all species of animals
including birds, mice and rats and it covers all
research that is funded by the National
Institutes of Health (NIH).
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Institutions covered by this policy, must
annually submit a written document called an
Assurance to NIH, which documents how the
institution is complying with all the regulations
covering animals used in research. The Office of
Laboratory Animal Welfare (OLAW) at NIH is the
agency that is responsible for enforcement of
this policy.
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B. Other Guidelinesi. Guide for the Care and
Use of Laboratory AnimalsThe Guide for the Care
and Use of Laboratory Animals ("The Guide") was
first developed in 1963 as a manual for research
facilities receiving public funding for research
using animals. The latest version of the Guide
sets specific standards for the care and use of
laboratory animals. It addresses institutional
responsibilities, husbandry and housing
standards, veterinary care and physical plant
specifications. It is written by experts in
laboratory animal care and is published by the
National Research Council.
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UMCES PolicyOur policy on animal care and use
follows federal and other laws and regulations.
It addresses the roles and responsibilities of
the Institutional Official (President Don
Boesch), the Institutional Animal Care and Use
Committee (IACUC), and the UMCES Community.
President Boesch appoints all IACUC
members.Note that our assurance with the PHS
restricts laboratory housing and manipulative
experiments on vertebrates to fish, amphibians,
and reptiles only. However, non-invasive field
studies on mammals and birds are permitted.
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The IACUC, which is a committee mandated by the
AWA and the PHS policy, reviews and must approve
all activities involving vertebrates at UMCES.
The AWA and PHS policy state membership
requirements for the committee

• 1 veterinarian (with laboratory animal
  background and responsibility at the
  institution),
• 1 member of the community (to represent the
  public interest),
• 1 scientist who uses animals in research, and
• 1 non-scientist member.University policy
  states that the committee should have at least 5
  members, currently our committee has 6 members.

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• The committee reviews all animal usage protocols.
  In addition, the committee ensures
• that the use of animals is necessary to answer
  a scientific question,
• a search for alternatives to the pain and
  distress is conducted and that pain and distress
  experienced by the animals is minimized, and
• that all the laws and policies for the use of
  laboratory animals are followed, including
  environmental safety

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The committee also ensures the humane care of
animals through the inspection of animal housing
and use facilities twice a year and by
investigating any complaints made regarding
animal use.The committee is also responsible
for reporting any instances of non-compliance and
recommending corrective action.
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C. Pain and Distressi. PainIt is difficult
to know how animals experience pain and distress.
The AWA defines a painful procedure in an animal
as "any procedure that would reasonably be
expected to cause more than slight or momentary
pain or distress in a human being to which that
procedure was applied, that is, pain in excess of
that caused by injections or other minor
procedures."
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DistressDistress is harder to define. Distress
differs from stress, which is a physiological
reaction that can lead to an adaptive response.
Distress is currently defined as "a state in
which an animal cannot escape from or adapt to
the external or internal stressors or conditions
it experiences resulting in negative effects upon
its well being" Principle IV of the US
Government Principles states that unless the
contrary is established, the assumption must be
made that a procedure that causes pain or
distress in a human being will cause pain and
distress in an animal.
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iii. AlternativesCurrent regulations stress
the need to search for and develop alternatives
to procedures on animals that cause more than
momentary pain or distress. The concept of the 3
"R"s has been used when thinking about
alternatives to animal use. This concept was
developed in 1959 by Russell and Burch in their
book The Principles of Humane Animal
Experimental Techniques. The 3 "R"s are
Replacement, Reduction, and Refinement.
Investigators at UMCES, who use animals that may
undergo more than momentary pain or distress,
must consider the 3 "R"s in the design of their
experiments or teaching protocols and must
demonstrate their search for alternatives.
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Replacement of animals with other systems may be
an option. Computer modeling or in vitro testing
may be a substitute for animal models. "Lower" or
non-vertebrate animals may be used in some
situations rather than a higher order animal.
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Reduction of the number of animals used for
research is also an important concept. This is
done mostly through experimental design and the
use of statistics.
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Refinement refers to methods that decrease the
amount of pain and distress experienced by the
animals that are actually needed to perform an
experiment. This is done through the use of pain
relieving measures such as anesthetics and
analgesics whenever possible.
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II. Use of Animals in Research and Teaching

• A. To use animals at UMCES you must
• Have an approved and up to date (active) animal
  use protocol
• Be certified by the IACUC to use animals in
  research or teaching
• Complete any additional training needed
• Occupational health, be up-to-date in
  vaccinations/testing, etc.
• Ensure the humane care and treatment of animals

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Hints on Animal Use Protocolsi. Always
download the most recent version of the animal
use protocol from the IACUC web site
http//www.umces.edu/about/iacucii. Answer all
the questions completely and attach relevant
appendices, etc., to protocol form as new end
pages. iii. Once the protocol is completed,
email the file as a single attachment to the
IACUC Office Assistant, Gail Canaday,
(canaday_at_umces.edu). Submit it well in advance
of your starting date, at least 2 months.
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iv. Also, mail a hardcopy with your signature and
that of your Laboratory Director to Gail.v.
Gail will then post the electronic copy to Moodle
and notify the IACUC members that a new protocol
is available for review.vi. IACUC members
generally review the protocol in 1 month, adding
their comments, if any, for all members to read.
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C. IACUC will Recommend One of the
Followingi. Approve the protocol, as
is.IACUC will send you a letter saying that the
protocol has been approved and you may begin work.
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ii. Approve with stipulations. This means that
IACUC had a few minor questions that needed
clarification before final approval. If this is
the case, you will receive a letter outlining the
questions that need clarification, or steps that
need to be taken before final approval is
granted. You respond to the committee in writing
and once the stipulations have been met, you will
receive a final approval letter.You may not
begin work or order animals until you receive
final approval.
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iii. Defer the protocol. If your protocol is
deferred, this means that IACUC did not have
enough information to approve or not approve your
protocol. Again, IACUC will write you a letter
outlining the questions they had and request
further information.iv. Not approve the
protocol. While this is rare, if a protocol is
not approved, IACUC will require you to submit an
entirely new protocol. IACUC will identify animal
welfare concerns and provide policy requirements
for a new submission.
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D. Protocol Number (example) F-AL-03-01Once
your protocol is approved, that approval is valid
for 3 years pending annual renewal. The protocol
will receive a number. The first letter, F or S,
designates faculty or student, the next 2-3
letters the laboratory (AL, CBL, or HPL), the
next 2 digits the year (04, 05, etc.), and the
last several digits the number of protocols
approved in that year. Faculty and student
protocols are numbered separately. The protocol
number is also used to identify animals. It
should be on the aquarium/cage cards for all
animals. A copy of the protocol, or the protocol
number should be available in any areas where
animals are taken or used.
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E. Continuing ReviewOnce your protocol is
approved, the IACUC will request a brief report
for an annual continuing review and renewal of
approval. You will receive correspondence from
the IACUC office regarding this continuing review
and your response is required in order for your
animal use protocol to remain active.F.
Three-year Re-reviewBased on federal
regulations, the protocol approval is valid for 3
years. If needed beyond 3 years, you will need to
submit well in advance of its termination date a
new, updated protocol for a de novo review by
the IACUC.
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G. Changes to ProtocolsAll changes to animal
use protocols must be approved by the IACUC
before they are initiated. Submit all changes in
protocol to the IACUC office in writing.i.
Very minor changes may be handled
administratively by the IACUC office.ii. Major
changes, such as a change in animal numbers, a
change in animal species, or changes in
objectives or procedures, will be reviewed by the
full committee.
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H. Closing a StudyIf you are closing your
study, inform the IACUC of this action by
requesting a change memo.
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I. Certification for Animal UseEveryone who
uses animals in research or teaching must be
certified by the IACUC. This certification is
accomplished through attendance at an IACUC
Training Seminar offered in October of each year.
All personnel must obtain this certification at
the earliest date following their employment at
UMCES. A Letter of Certification will be mailed
to you stating that you have completed IACUC
training and when.
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J. Occupational Healthi. Be aware of
occupational health issues related to your work
(see laboratory safety officer). For example,
zoonoses are diseases that can be passed between
humans and other animals. You should be aware of
some of the zoonotic diseases carried by the
species that you are working with.Check out
Center for Disease Control and
Preventionhttp//www.cdc.gov/DiseasesConditions/
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ii. Tetanus vaccinationIt is required that all
personnel who work with animals be vaccinated for
tetanus.iii. Rabies vaccinationIf you are
working with bats or other carnivores, it is
recommended that you receive the pre-exposure
rabies vaccination.
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Other TrainingWe expect that only trained,
experienced personnel will capture, mark, track,
transport, take tissue or fluid samples, perform
surgery, or euthanize laboratory or wild animals.
If this training is not obvious to the IACUC or
is insufficient, we may stipulate that such
training be completed to our satisfaction before
beginning the research.
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An additional note Semi-annual facility
inspectionsRepresentatives of the IACUC conduct
site visits every 6 months to ensure that
approved protocols are being followed.Some
issues we are particularly stringent about1.
Labels on holding tanks/cages (as appropriate)
must be present listing the approved protocol
number, species, numbers, etc. Blank forms are
available on the IACUC web site.2. Husbandry
logs must be available showing feeding, cleaning,
water quality check histories.3. Food must be
properly stored and labeled.