University of Wyoming
Institutional Animal Care and Use Committee
Scientist Involvement








1950- Animal Care Panel (ACP)
1951- Proceedings of the ACP published
1952- Institute of Laboratory Animal Resources
1960- Animal Facilities Certification Board
1963- Guide for Laboratory Animal Facilities and Care
1965- AAALAC incorporated
1965- 2nd edition of “The Guide” published; 7th edition
published in 1996
1967- ACP became AALAS
Government Involvement






1962- NIH Contract – First “Guide”
1966- Laboratory Animal Welfare Act
1970- Animal Welfare Act (’70, ’76, ’85’ 90,
2002)
1971- NIH “Policy”
1973- Public Health Service Policy (’79, ’85)
1985- PHS Act (Health Research Extension Act)
1966 Laboratory Animal Welfare Act



Focus on preventing theft of dogs and
cats
Holding areas emphasized
Only developed specific areas of standards

Housing, Feeding, Watering, Sanitation,
Shelter, Separation of species, Ventilation,
Veterinary care
Animal Welfare Act





1970 the LAWA changed to AWA
Extended to the laboratory
Reported number of animals by pain
category
Required appropriate use of anesthetics
No ACUC yet
1971 NIH Policy





Institutions had to have “Assurances”
Annual inspections
Compliance with AWA
Follow the “Guide”
1973 Public Health Service Policy followed
1979 PHS highlights




IACUC now required
Assurance required before funding
received
All live vertebrates
Annual reports required

Recommended to have protocol reviews
1985 AWA Amendments








Established the IACUC
Assigned responsibility to Institutional Official
(IO)
Protocol review
Semiannual inspection and program review
Search for alternatives to painful procedures
Personnel qualifications
Environmental enrichment
Exercise for dogs
1985 PHS Policy







More detailed Assurance
IO ultimately responsible
IACUC members are appointed by CEO
Minimum of 5 members
Protocol reviews required
Semiannual reports of program review
Detailed training program description
UW IACUC












Bill Gern, Institutional Official
Dorothy Yates , Liaison to Institutional Official
Linda Osterman, Coordinator
Colette Kuhfuss, Coordinator
Dave Evertson, Attending Veterinarian
Dan Rule, IACUC Chair, Animal Science
Scott Seville, Zoology and Physiology
Sreejayan Nair, School of Pharmacy
Myrna Miller, Veterinary Sciences
Bob Boysen, Unaffiliated member
Ashley Guritza, UW General Council,
Tara Evans, UW General Council
IACUC Protocol Preparation
FOR IACUC USE
Approved for period (one year maximum)
Approved ______________ to ________________
Copy to PI ________________________________
Copy to Animal Care Worker _________________
DHHS/NIH/OLAW ASSURANCE #A-3216-01
EFFECTIVE: 08/26/05-08/31/09
UNIVERSITY of WYOMING
INSTITUTIONAL ANIMAL CARE and USE COMMITTEE
PROTOCOL APPROVAL FORM
Submit completed form to the IACUC, Office of Research, Room 308, Old Main.
RESEARCH SHALL NOT BEGIN BEFORE THIS FORM IS APPROVED.
New project ____________
Revised protocol ____________
Date________
Title of project :
Project leader(s):
Department(s):
Phone:
Email:
Type: Research _____
Instruction ______
Location of animal room: Building/Room number
Location of animal care log book/medical records: Building/Room number
Duration of project: Begin
End
(Project will be approved for one year from date of IACUC approval. An update form must be submitted annually if project extends beyond one year.)
Sponsoring agency (if applicable):
UW Budget ID/Project Grant number (if applicable):
Name person(s) and/or unit responsible for animal care:
Name:
Phone:
Animal species (genus, species, common name) (one species per protocol form):
Number to be used/year:
Total animal days/year (# animals x #days):
Number to be used/project:
Total animal days/project:
Source of animals:
Commonly overlooked
Animal species (genus, species, common name) (one species per protocol form):
Number to be used/year:
Total animal days/year (# animals x #days):
Number to be used/project:
Total animal days/project:
Source of animals:
Is simple math, but quite often the number of animals
indicated on this page does not match up with the numbers
indicated in the description of the research
Proposal category:
A _____ Live animals will be humanely killed without any treatments, manipulations, etc.,
but will be used to obtain tissue, cells, sera, etc.
B _____Live animals will have manipulations, surgery, etc. performed while anesthetized.
The animals will be humanely killed at termination of the experiment without regaining consciousness
(non-survival surgery).
C _____ Live animals will receive a painful stimulus of short duration without anesthesia
behavior experiments with flight or avoidance reactions) resulting in a short-term traumatic response.
Other examples in this category are blood sampling, injections of adjuvant, etc.
D _____ Live animals will have significant manipulations, surgery, etc., performed while
anesthetized and will be allowed to recover (survival surgery). Such procedures (e.g., chronic catheters,
surgical wounds, implants) cause a minimum of pain and/or distress. Also included are mild toxic drugs
or chemicals, tumor implants (including hybridomas), tethered animals, short-term restrained animals.
E _____ Live animals will have significant manipulations, surgery, severe discomfort, etc.
without benefit of anesthesia, analgesics or tranquilizers. Examples are toxicity testing, radiation sickness,
irritants, burns, trauma, biologic toxins, virulence challenge, prolonged restriction of food or water intake,
cold exposure, restraint, or drug addiction. All use of paralytic agents (curare-like drugs) must be included
in this category.
O _____ Other: Standard husbandry practices, weighing, observation, insemination.
Choice of category??



If not clear on which category to check,
be conservative
Check the next highest category to make
sure the project is covering the bases
adequately
The IACUC review will compare
procedures with category chosen
1)
a. Purpose (in
lay terms)
b. Scientific objective(s)
Potential for use of in vitro systems or computerized models instead of live animals
i.
Elaborate on current availability of animal data that could be used to predict outcomes
ii. Elaborate on the uniqueness of the study such that the requirement for live animal
research is necessary
Purpose – in “lay terms”



Should be written at a high school level
The nature of the study and the relevant
benefactors should be indicated
For example, if the study is to benefit
agricultural production, say so



Biomedical
Veterinary medical
Environmental, zoological, etc.
1)
a. Purpose (in
lay terms)
b. Scientific objective(s)
Potential for use of in vitro systems or computerized models instead of live animals
i.
Elaborate on current availability of animal data that could be used to predict outcomes
ii. Elaborate on the uniqueness of the study such that the requirement for live animal
research is necessary
This is where you justify the use of animals for the
research.
- “In vitro or comperized models cannot be use because…”
- “The current animal data indicates….; however,…..”
- “The proposed study is unique because….; therefore,
new animal research is necessary to address the problem.”
2) Describe all procedures: Description should allow the IACUC to understand the experimental course of
an animal from its entry into the experiment to the endpoint of the study.
Overview of procedures
(Reference citations for b-e)
b.
Type and duration of restraint
c.
Name and dose of anesthesia and/or tranquilizer (contact attending veterinarian)
d.
Surgical procedures
i. pre-operative procedures
ii. asceptic methods to be used: surgical attire
iii. who will perform surgical procedures
iv. where will surgical procedures be performed
v. non-survival/survival surgery
vi. justification if more than one surgical procedure per animal
Post-surgical care
i. Recovery facility
ii. Name, dose, route of administration and regimen for analgesia;
(investigate literature for pain management for species used;
consult attending veterinarian)
2) Describe all procedures: Description should allow the IACUC to understand the experimental course of
an animal from its entry into the experiment to the endpoint of the study.
Overview of procedures
(Reference citations for b-e)
b.
Type and duration of restraint
c.
Name and dose of anesthesia and/or tranquilizer (contact attending veterinarian)
d.
Surgical procedures
i. pre-operative procedures
ii. asceptic methods to be used: surgical attire
iii. who will perform surgical procedures
iv. where will surgical procedures be performed
v. non-survival/survival surgery
vi. justification if more than one surgical procedure per animal
Post-surgical care
i. Recovery facility
ii. Name, dose, route of administration and regimen for analgesia;
(investigate literature for pain management for species used;
consult attending veterinarian)
Describe procedures




Be thorough
Address each item
If not conducting surgery, address with
“N/A”
A “copy and paste” would work here, but
be succinct – no need for numerous
paragraphs and pages from your grant
proposal
3) Justification for species chosen (lowest possible species on phylogenetic scale)
“lowest species on the phylogenetic scale”




Example – you propose to use sheep
Why can’t you use a mouse?
Some examples of why have included the
specialized GI tract; the presence of a large
enough pituitary to study; characteristic
reproductive cycles
Start the sentence with “The (species) is the
lowest species on the phylogenetic scale
because……” finish the sentence
4) Statistical justification for the specified number of animals
(assistance to determine the appropriate number of animals per treatment)
a. Justification for number of animals per experiment
b. Justification for number of experiments per year (as stated on page 2)
c. Literature cited/reviewed for justification of number of animals proposed
Statistical Justification


The same statistical justification used in a
grant proposal should be used here
Examples of what NOT to use include:



Number chosen based on number of cages or
pens
Based on available financial resources
Based on what you used last time
Statistical Justification




If you need to add animals because of
expected mortality, say so
Don’t add animals just because more
would be better
The idea is to use enough to obtain data
worthy of interpretation
Too few or more than necessary could be
a red flag
Statistical Justification



If previous studies demonstrate how the
proposed number is appropriate to test your
hypotheses, cite the work
If the number is larger than capacity, propose to
replicate the treatments to achieve the
appropriate number
If no data are available, propose the study as a
pilot trial to obtain base line data that can be
used to calculate the appropriate “n”
Power tests







Power tests are often used to establish “n”
Some data are required
Pilot studies, literature
Statistics books, stat analysis software
Research Office web page links
Consult (collaborate) with a statistician
Power test may not be best approach
Will animals be subjected to euthanasia?
a. Method of euthanasia
b. Drug and dosage
c. If using drugs for euthanasia, describe disposal of animal remains.
d. If animals will not be euthanized, describe plan for future use or other
dispersal.
Landfill disposal




If euthanasia method includes use of drugs for
which residues could be consumed by birds of
prey, such as eagles, this could be a problem
Indicate that landfill personnel will be instructed
to bury the remains immediately
There is a charge for the service, so a contract
could be needed
For rodents, incineration at the Pharmacy facility
is a good approach
If the proposal category checked is D or E, then the experimental procedures may
cause more than momentary or slight pain or distress. Address the following:
Provide written narrative description, including methods and sources used in search,
of how it was determined that alternatives to potentially painful or distressful procedures
are not available.
Including
i: Literature cited; database references must include name of databases
searched, the date of the search, period covered, and keywords used.
And/Or
ii: personal communications
Please refer to Animal Welfare Act 9CFR Section 2.31 (d) (1) (ii)
Category D and E





Requires the most attention
Requires a thorough search for and discussion of
alternative procedures
Search key words should include in the list “alternatives”
along with key words pertinent to the research area
Alternative procedures that could be less painful and less
stressful might not be appropriate for your study;
indicate why
Your procedure might be a less painful and stressful
modification of published procedures – i.e. the
alternative. If so state that it is the alternative
Addressing the issue of
“D” and “E” category




Be thorough
Actually look for alternatives
Who knows, you might find something
useful
If not, at least you tried, and this is what
is most important for the protocol
reviewer
Explain why this research does not involve unnecessary duplication of previous
research or experiments.
Describe the literature search method.
a. If using a web-based database search, indicate date of search, name of
database, keywords used, and number of responses.
b. Discuss relevant literature to justify why unnecessary duplication of previous
research is not involved.
Please refer to Animal Welfare Act 9CFR Section 2.31 (d) (1) (iii)
…..unnecessary duplication….





Appears redundant
If the research proposed has not been done before, you
would or should know this
Indicate the search engine and key words
Some studies are closely related, but the hypotheses
were clearly different so the approach would be different
Plan to “split hairs” as the difference might not be
obvious to a reviewer who is not as closely associated
with the work as you are – keep the language simple
and clear
Training/experience documentation: Federal regulations require appropriate training
and experience for all personnel involved in the care and use of animals.
An up-to-date "Verification of Training for Animal Work" form must be on file in the
Research Office for each person, including the P.I., involved in the care and use of
animals to be used in this protocol.
Verification of Training for Animal Work form: http://www.uwyo.edu/Research/forms.htm
For PI(s) (name):
attached ___ on file ___ date _____________
For animal care worker/lab technician (name): attached ___ on file ___ date _____________
Graduate student(s) (name):
attached ___ on file ___ date _____________
Others (name):
attached ___ on file ___ date _____________
Please list specific experience and/or qualifications of each animal care worker necessary to
perform the specific techniques and procedures described in this protocol (such as surgery)
if not included on the "Verification of Training for Animal Work" form attached or on file.
Training




Get the training certification from the Research
Office web page
Fill it out and submit it
Once on file, reference this item as “on file”
Everyone who is involved in animal research is
required to take the CITI online training to be
compliant with UW assurance
Principle Investigator Assurance: "I have received a copy of the NIH Guide for the Care and Use of
Laboratory Animals and/or The Guide for the Care and Use of Agricultural Animals in Agricultural Research
and Teaching and will provide for the care, use and treatment of the animals used for the purpose described
above accordingly. I will use procedures which will avoid or minimize discomfort, distress and pain to animals
used in my research. I have considered alternatives to procedures that may cause more than momentary
slight pain or distress to the animals. These studies do not unnecessarily duplicate previous experiments.
I HAVE CONSULTED AS NEEDED WITH ATTENDING VETERINARIAN (David Evertson 7457341), OR BACKUP VETERINARIAN ON STAFF AT ALPINE VETERINARY CLINIC,DURING
THE PLANNING OF THIS PROJECT AND WILL CONSULT WITH THE VETERINARIAN
DURING THE PROJECT. I will inform
the attending Veterinarian immediately if any problems occur, including unanticipated pain or distress, injury,
morbidity or mortality. I will submit a revised protocol for IACUC approval if any significant deviation from the
approved project procedures occurs. I will submit an annual update for IACUC approval for continuation if this
project extends beyond one year. I assure the IACUC that all persons involved in the care and use of animals
used to conduct this protocol have received the appropriate training and are qualified to perform the
procedures described above."
Principle Investigator Assurance: "I have received a copy of the NIH Guide for the Care and Use of
Laboratory Animals and/or The Guide for the Care and Use of Agricultural Animals in Agricultural Research
and Teaching and will provide for the care, use and treatment of the animals used for the purpose described
above accordingly. I will use procedures which will avoid or minimize discomfort, distress and pain to animals
used in my research. I have considered alternatives to procedures that may cause more than momentary
slight pain or distress to the animals. These studies do not unnecessarily duplicate previous experiments.
I HAVE CONSULTED AS NEEDED WITH ATTENDING VETERINARIAN (David Evertson 745-7341), OR
BACKUP VETERINARIAN ON STAFF AT ALPINE VETERINARY CLINIC,DURING THE PLANNING OF
THIS PROJECT AND WILL CONSULT WITH THE VETERINARIAN DURING THE PROJECT. I will
inform the attending Veterinarian immediately if any problems occur, including
unanticipated pain or distress, injury, morbidity or mortality. I will submit a revised protocol for
IACUC approval if any significant deviation
from the
approved project procedures occurs. I will submit an annual update for IACUC approval for continuation if this
project extends beyond one year. I assure the IACUC that all persons involved in the care and use of animals
used to conduct this protocol have received the appropriate training and are qualified to perform the
procedures described above."
The assurance



By signing, the investigator, department
head, ACUC chairman, and IO assure that
all indicated will be done
Is a contract
The University of Wyoming also has
submitted assurances that the IACUC
must act according to established
guidelines
Annual Updates





If there are no changes, indicate
“No Changes”
Indicate the number of animals proposed
for the previous year from the original
protocol
Indicate the number actually used
If the numbers used and proposed are
different, that is a “Change”
Indicate the number proposed for
upcoming year
Reminders and helpful hints on commonly
overlooked items:
New protocols:
○ Genus and species are indicated.
○ For blood draws/injections: location on animal; volume; needle
dimensions are given.
○ If anesthesia and/or euthanasia are proposed the dosages are
indicated along with injection location, volume, and needle dimensions.
○ For all personnel on the protocol each has appropriate CITI training
completed.
Reminders and helpful hints on commonly overlooked items:
New protocols:
○ For a category “D” or “E” protocol, the literature search for alternatives
has been done with the search key words including the term “alternatives”
in the list along with the search engines used.
○ For statistical justification, calculations of “n” are included with
reference(s); for pilot studies the verification of lack of sufficient data or
published data from other labs is included.
Reminders and helpful hints on commonly overlooked items:
Annual updates:
○ For annual updates in which the work done was approved as a pilot study,
the continuation of the project will likely not be a “pilot” study as sufficient
data for calculation of animals numbers; statistical justification of “n” will be
needed in the annual update for additional animal experiments.
○ For annual updates, any change in the number of animals is
indicated with brief justification.
Indicate the number proposed in the original protocol; the number used
during the year of the update, and the number to be used in the upcoming
year.
Please remember that all investigators (even DVMs) are required to contact
the Attending Veterinarian if any issues regarding the health and well-being of
the animals on protocol occur!
Additional Protocols




Teaching protocol
Breeding colony protocol
Wildlife in development
Electronic versions planned
FOR IACUC USE
UNIVERSITY OF WYOMING
INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE
Required informational sheet for instruction involving the use of animals
Semester/ year approved for instruction
involving the use of animals: __________
The informational sheet must be filled out and submitted by the faculty member instructing the class using the
animals before the first day of class during the semester in which the students will be using the animals.
This sheet should be used for class projects or assignments designed to provide students with an opportunity to work
with animals as part of a class. If the animals will be used in research, research training, experimentation, biological
testing, or exhibition purposes, the faculty member or student must submit a full IACUC protocol.
The informational sheet should be submitted to the IACUC in care of:
Institutional Animal Care and Use
Committee
1000 East University Avenue,
Dept. 3355
Room 308, Old
Main
Laramie, WY 82071
Name:
Title:
Institution:
Department:
Phone: 307-766-5320
Fax:
307-766-2608
email: IACUC@uwyo.edu
Phone:
Fax:
Email:
Address:
2) Title, semester of class.
3) Purpose for the use of the animals (in lay terms).
4) Description of the procedures, including:
- Overview of procedures
- Number of animals and species
- Type and duration of restraint
- Name and dose of anesthesia and/or tranquilizer (contact
attending veterinarian)
- Surgical procedures and post-surgical care
- Justification for species chosen (lowest possible species on
phylogenetic scale)
- If euthanasia will be used, include (1) the method, (2) the drug
and dosage, and (3) the disposal of the animal remains. If animals
will not be euthanized, describe plan for future use or other
dispersal.
5) Describe the training that will be provided to the
students to ensure that they are appropriately qualified
and trained to conduct the procedures.
6) Attach a copy of the course syllabus and any other
relevant information (e.g., lab manual)
Required Training



CITI training online
Do not have to re-take if done previously
elsewhere
Required by everyone
Summary




IACUC is important
Contact the ACUC with questions
Expect protocol revisions
The ACUC will try to make the process as
straight forward as possible for the
researchers