Transcript Institutional Animal Care and Use Committee (IACUC) Field

Institutional Animal Care and Use
Committee (IACUC)
General Information
J. Edward Gates, Ph.D.
Committee Chair
Appalachian Laboratory
University of Maryland Center for Environmental
Science
UMCES IACUC Members:
• J. Edward Gates, Appalachian Laboratory,Chair and
Scientist Member
• John L. Hoogland, Appalachian Laboratory, Scientist
Member
• Christopher L. Rowe, Chesapeake Biological
Laboratory, Scientist Member
• Andrew M. Lazur, Horn Point Laboratory, Scientist
Member
• Erica Kropp, Center Administration, Non-scientist
Member
• Bruce Taliaferro, Hickory Environmental Education
Center, Community Representative
• Janet E. Whaley, National Marine Fisheries Service,
Veterinarian
General Information
I. Ethics of Animal Use in Research
The 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.
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.
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.
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. For a discussion about
the differences between animal rights and animal
welfare, please see:
http://www.sover.net/~lsudlow/ARvsAW.htm
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.
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.
A.
Laws and Regulations
i. 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/usdaleg1.htm
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.
ii. Public Health Service (PHS) Policy
The 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/grants/olaw/references/phspol.htm#
USGovPrinciples
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).
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.
B. Other Guidelines
i. Guide for the Care and Use of Laboratory Animals
The 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 (1996) 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.
ii. UMCES Policy
Our 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.
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 7
members. All UMCES laboratories are represented.
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
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.
C. Pain and Distress
i. Pain
It 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."
Pain can be acute, short lived, or chronic. The signs
manifesting acute or chronic pain may differ and may be
different in different species.
ii. Distress
Distress 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.
iii. Alternatives
Current 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.
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.
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.
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.
II. Use of Animals in Research and Teaching
A. Animal Use Form
To use animals at UMCES you must:
i.
ii.
iii.
iv.
v.
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
B.
Hints on Animal Use Protocols
i. Always download the most recent version of the
animal use protocol from the IACUC web site in
either WordPerfect or MSWord formats,
http://www.al.umces.edu/iacuc
ii. Answer all the questions in Part A and Part B
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, Paulette Orndorff,
[email protected]. Submit it well in advance
of your starting date, at least 2 months.
iv. Also, mail a hardcopy with your signature and that of
your Laboratory Director to Paulette.
v. Paulette will then post the electronic copy to
blackboard.com 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.
C. IACUC will Recommend One of the Following:
i. Approve the protocol, as is.
IACUC will send you a letter saying that the protocol has
been approved and you may begin work.
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.
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.
D. Protocol Number (example) F-AL-03-01
Once 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.
E. Continuing Review
Once 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-review
Based 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.
G. Changes to Protocols
All 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.
H. Closing a Study
If you are closing your study, inform the IACUC of this
action by requesting a change memo.
I. Certification for Animal Use
Everyone 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.
J. Occupational Health
i. 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 Prevention
http://www.cdc.gov
http://www.cdc.gov/DiseasesConditions/
ii. Tetanus vaccination
It is required that all personnel who work with animals be
vaccinated for tetanus.
iii. Rabies vaccination
If you are working with bats or other carnivores, it is
recommended that you receive the pre-exposure rabies
vaccination.
K. Other Training
We 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.
A Good Source for Information on Euthanasia:
AVMA Guidelines on Euthanasia (American Veterinary
Medical Association 2007)
http://www.avma.org/issues/animal_welfare/euthanasia.pdf