James Madison University Institutional Animal Care and Use Committee
Animal Use Protocol (AUP)
(for Laboratory Animal Research or Teaching)
FOR OFFICE USE ONLY:
Protocol #:
Date Received:
1. Administrative Information (PLEASE SINGLE CLICK ON SHADED BOXES TO TYPE)
Project Title:
Project Dates:
From:
To:
(Not to exceed 3 years minus 1 day)
MM/DD/YYYY
MM/DD/YYYY
Principal Investigator:
E-mail address:
Phone Number:
Lab Phone Number:
Department:
Address (MSC):
Type of Project:
Laboratory Animal Research
Teaching
If Teaching:
Course #
Course Title:
Previously approved protocol
number (if applicable):
Use of recombinant DNA and synthetic nucleic acid molecule research:
Yes
No
Institutional Biosafety
If “Yes,” approval received:
Yes
No
Pending
Committee Review/Approval:
IBC Protocol Number(s):
Biosafety Level(s):
2. Project Funding (if applicable)
Funding Source
OSP Proposal #
VAVA-
Start Date
End Date
Principal Investigator(s)
3. Experience and Training
List all persons working on this protocol. All individuals listed must satisfactorily complete all pertinent CITI training
modules and enter the date below. In addition, face-to-face training of specific research and safety procedures
must be provided by the Principal Investigator (PI) BEFORE students begin working with the animals. Those
untrained in specific research and safety procedures must also be closely supervised by the Principal Investigator
(PI) while learning these procedures.
Name:
Hands-on
Training (in the
Lab):
CITI Working
with the IACUC
Training:
CITI Species
Specific Training:
SOP Training Date(s):
4. Project Summary for Layperson
In lay language, briefly summarize the overall intent/objectives of the study. Remember, your target audience for
this summary is a non-scientist. A suggestion is to write the summary on a high school grade reading level. Explain
your project using terminology and concepts that are understandable to a non-scientist reader. Keep in mind your
reader may not have background in specific procedures you are describing. Avoid terms and acronyms that are
specific to your research field. Research protocols are commonly requested under the Freedom of Information Act
(FOIA) and State Open Records. Should the university receive a request under FOIA or the state open record law,
the summary ought to be written in such a way that the general public can understand.
Harm/Benefit Analysis: In 2-3 sentences and using lay language, compare the potential harm to participating
animals with the potential benefits of the research for humans, animals and/or the advancement of science.
5. Animals
Complete a separate column for each species or rodent strain to be used. If more than 3 species or strains are to
be used, duplicate this page and insert appropriately. Please include all information that applies to the animals you
propose to use in this protocol/proposed research.
NOTE: We recommend including enough animals to cover unforeseen circumstances, such as loss of animals.
A
B
C
a. Species (common name)
b. Strain
c. Gender
M
F
M
F
M
F
d. Age range
e. Weight range
f. Number of animals/project year
Year 1:
Year 2:
Year 3:
Year 1:
Year 2:
Year 3:
Year 1:
Year 2:
Year 3:
g. Vendor/Source
h. Building and room number where
animals will be housed
i. Building and room number where
project will be performed
j. If location of project is different from
animal facility where housed, are
animals housed for longer than 24
hours in this area?
Yes
k. Does this project require breeding
of animals?*
Yes
No
N/A
Yes
No
N/A
No
Yes
Yes
No
N/A
No
Yes
No
*NOTE: If you frequently need to breed animals for multiple studies, or if breeding is a typical part of your
research, you may want to submit a breeding protocol. Please use this template and indicate it is for breeding of
animals for use on future studies.
6. Study Objectives
a. In scientific language, provide a project summary describing the purpose of the study. Briefly explain the aim
of the study and why the study is important to human or animal health. If this is a triennial resubmission,
include an update of how far the project has proceeded up to this point and how the data will be expanded
upon in the next 3 years.
b. List the specific aims or objectives for the project:
c. Please describe how animals will be monitored after normal work hours, weekends, and holidays:
d. Does your project involve any of the following procedures? Please select the applicable boxes below and follow
related instructions.
Yes
Procedure
Animal identification methods (e.g., ear tags, tattoos, collar, cage card, implant, etc.) Please specify:
Breeding
Blood collection
Anesthesia
Non-survival surgery
Animal pain or distress
Prolonged restraint (physical restraint of a conscious animal lasting longer than 30 minutes)
Animal work done at another institution
Survival surgery (Please attach Form I: Surgery)
Illness, induced disease, or pathological condition (Please attach Form II: Disease.)
Special diets and/or food or water restriction (Please attach Form III: Dietary.)
Immunizations (Please attach Form IV: Immunization.)
Hazardous Materials (exogenous tumors, cells lines, hybridomas, biohazards, isotopes, etc.)
(Please attach Form V: Hazardous.)
e. Provide a detailed description of the use of animals. All procedures to be employed in the study must be
described. This description should allow the IACUC to understand the course of an animal from its entry into
the project to the endpoint of the project. Cover all items checked above as instructed in the table. A best
practice is to provide an acceptable range of the specific items described below to allow flexibility in the use
of professional judgment and avoid non-compliance due to work conducted off protocol as a result of overly
restricted parameters.
7. Justification for Animal Use
a. Describe the number of animals to be used for each procedure in the table below.
Procedure
Example: Oral gavage
Animals per
Group
10
Groups per
Procedure
10
Procedures per
Year
1
Animals per
Year
100
*If this table does not fit with your study, you may create your own. However, the same information needs to be conveyed.
b. You arrived at these numbers by (select all that apply).
Power analyses indicate that the proposed number of experiments is the lowest required for
statistically valid tests of the hypothesis. The number of animals should be the minimum number
required to obtain statistically valid results. Include justification for group size through a power
analysis when possible:
The experiments will compare the effects of several independent variables and therefore require
many groups or cohorts.
The outcome measures or phenomena being measured are variable and large sample sizes are
necessary for statistically valid sampling.
Differences from controls are expected to be small, and large sample sizes are necessary to
distinguish differences reliably.
The experiments are technically difficult and multiple attempts will be needed to obtain satisfactory
data from each experiment.
Other (explain):
c. What is the rationale for using animals in this study? Select all that apply.
This research requires behavioral measurements from living animals.
This research requires biological measurements or tissue samples from living animals.
Computer or other models cannot be used to replace animals in this research.
The research cannot be done in vitro.
This research is a direct extension of previous work on this species.
This research seeks to extend previous findings from other species specifically to this species.
Nothing is known about the physiological/behavioral phenomena of interest in this species.
More is known about related aspects of the physiological/behavioral phenomena of interest in this
species than any other.
This species represents the best compromise between the simplest (lowest) organism that can be
used and the most relevant model system for human physiology/behavior.
This species is the most cost-effective for the proposed research.
Other (explain):
d. Search for alternatives to the use of live animals.
A literature search for alternatives to the use of live animals is required. Please provide the details of your
search below:
i. List a minimum of 2 databases consulted (e.g. PubMed, Scopus, Toxline, Biological Abstracts, etc.).
(1)
(2)
Additional databases:
ii. Date of search:
iii. Years covered by search:
iv. Please provide a brief justification of date range used in search (e.g., anything past a certain date is
outdated):
v. Key words or search strategies used (e.g., models, in vitro, pilot, tissues, etc.):
vi. Provide a brief summary of your search results:
8. Experimental Stress and Pain
a. Prolonged Restraint
i. Does this protocol/proposed research involve prolonged restraint (e.g. animals held in slings or small
confinement apparatus)? Note: brief restraint, for the purpose of performing routine clinical or
experimental procedures need not be described. Yes
No
ii. If YES, indicate frequency and duration of restraint and describe the method of restraint and the
rationale for its use.
b. Research-related Stress:
i. Will the animals be subjected to stressful conditions such as high intensity light or noise, water
immersion of electrical shock as part of your project: Yes
No
ii. Describe the stressor, its level and frequency, and the rationale for it use.
c. If conducting blood withdrawals, please describe the volume, frequency, withdrawal site(s), and
methodology:
d. If conducting tail biopsies or tail bleeding, please describe procedure in detail:
e. Please provide a plan of action that will be followed in case of animal illness (i.e., initiate treatment, call
investigator prior to initiating treatment, euthanasia):
f.
Please describe the experimental endpoint criteria as defined in the SOP for Euthanasia (e.g., tumor
size/appearance, percentage body weight gain/loss, inability to eat or drink, behavior abnormalities, clinical
symptomatology, or signs of toxicity):
g. Indicate the appropriate pain and distress category(ies) and the number of animals in each. Sums should
equal the total animals from Section 5 above.
http://www.aphis.usda.gov/animal_welfare/downloads/Animal%20Care%20Inspection%20Guide.pdf, Policy # 11.
Pain and Distress Category
(based on USDA categories)
Pain and distress category B – holding or breeding
Number of animals per year
Year 1
Year 2
Year 3
Totals
Pain and distress category C – minimal, transient, or
no pain or distress
Pain and distress category D – pain or distress
relieved by appropriate measures
Pain and distress category E* - unrelieved pain or
distress
*For category E animals, a scientific justification is required to explain why the use of anesthetics, analgesics,
sedatives or tranquilizers during and/or following painful or distressful procedures is contraindicated.
For category D and E animals, you must conduct a targeted literature search for alternatives to painful and
distressful procedures. Please provide detailed results of your literature search below.
i. List a minimum of 2 data bases consulted (e.g., PubMed, Toxline, Scopus, Biological Abstracts, etc.).
(1)
(2)
Additional databases:
ii. Date of search:
iii. Years covered by search:
iv. Please provide a brief justification of date range used in search (e.g., anything past a certain date is
outdated):
v. Key words or search strategies used (e.g., analgesics, reduce pain, non-invasive, training):
vi. Provide a brief summary of your search results:
9. Euthanasia and Final Disposition of Animals
a. If animals will not be euthanized, select disposition:
Return to colony, flock, or herd
Adoption (http://www.jmu.edu/researchintegrity/iacuc/forms/adoption-release-form.doc)
Experimental animals may be transferred to another AUP for non-survival procedures. Breeders and
non-experimental animals may be transferred to another AUP.
Other:
b. If animals will be euthanized, check method(s) of euthanasia:
Carbon dioxide (CO2)-induced hypoxia followed by a secondary mechanical means of euthanasia
If secondary, please specify:
Exsanguination under anesthesia.
Perfusion under anesthesia.
Injectable agent overdose.
Decapitation. If used without prior anesthesia, you must provide scientific justification below*
Cervical dislocation. If used without prior anesthesia, you must provide scientific justification
below*
Other method of euthanasia. Please specify:
*Provide scientific justification for decapitation or cervical dislocation without anesthesia here:
10. Use of Anesthetic Agents/ Drug Enforcement Agency (DEA) Regulated Controlled Substances
**Please see the Guidelines for Use of Non-Pharmaceutical Grade Drugs
a. Will this project involve any DEA regulated controlled Substance? Yes
No
If you answered YES:
i. The PI will have a DEA license (or have applied for a license) BEFORE use of controlled substances
under this AUP.
Provide name on license and license number or the application confirmation number.
ii.
iii.
iv.
The PI will include the proposed use of controlled substances at appropriate doses.
The PI will provide appropriate security (anchored cabinet with a minimum of 2 separately keyed
doors and limited access to keys or lock combinations) for controlled substances.
The PI will be responsible for keeping records of controlled substance use.
b. Are the controlled substances to be used listed in either the anesthesia, euthanasia, or analgesia sections of
this protocol?
Yes
No
Note: You must be individually licensed or have applied for a license with the DEA to use controlled
substances at James Madison University. By signing this animal use protocol/proposed research you agree
to abide by all JMU policies and procedures for use of controlled substances. Unauthorized use of DEA
controlled substances may result in suspension of the protocol.
c. Specify in the table below the anesthetic agent for each procedure. Where anesthetic combinations are
called for, list each drug separately. Researchers are encouraged to list potential drugs they may use in order
to provide for flexibility.
Procedure
Drug
Dose
Route
Expected Duration of
Anesthesia
d. Volatile (gas) anesthetic agents.
i. Are you using a volatile anesthetic (e.g. isoflurane)? Yes
No
ii. How will this be vented (e.g., fume hood) or scavenged (e.g. charcoal canister)?
iii. List the location of the venting or scavenging equipment.
e. List who will administer the anesthesia and the qualifications of each person listed.
11. Principal Investigator’s Statement
POLICY: It is University policy that the procurement, housing, care and use of animals should conform to the National
Research Council Guide for the Care and Use of Laboratory Animals Eighth Edition (the Guide) or succeeding Editions
and other relevant federal policies and procedures. The policy applies to all student/faculty research and teaching
whether funded from external or internal sources. Please refer to the policy located at the following web address:
http://www.jmu.edu/JMUpolicy/2202.shtml for additional guidance.
I certify (select box) that the statements made in this request are accurate and complete and that the animal
usage in this protocol/proposed research does not unnecessarily duplicate previous experiments.
If I receive approval for this project, I agree to inform the IACUC in writing of any adverse events or
unanticipated problems (http://www.jmu.edu/researchintegrity/iacuc/forms/iacuc-adverseevent.doc). I further agree not to proceed with the project until the problems have been resolved.
I will not make minor or significant procedural changes to procedures involving animals without
submitting a written amendment to the IACUC and will not undertake such changes until the IACUC
has reviewed and approved them.
I agree not to take visitors, including the media, into the animal facility without prior approval by the
IACUC and my Department Chair.
All photographs and videotapes of research animals and/or personnel will be for documentation of
my research and for scientific purposes only.
It is my responsibility to ensure that every person working with animals is appropriately trained.
I will not begin work on the procedures described in this protocol/proposed research until I receive
notice of approval from the IACUC.
I will keep a copy of this protocol/proposed research and all subsequent correspondence.
I have completed the Occupational Health Risk Assessment form and will ensure additional
personnel also complete the Occupational Health Risk Assessment form.
I agree to follow all laboratory safety procedures and wear the following protective gear when
handling animals: lab coats, surgical gloves or other hand protection, and facemasks when
appropriate.
I agree to read and document that I have read and understood all applicable Standard Operating
Procedures.
I will ensure that all personnel will read and document that they have read and understood all
applicable Standard Operating Procedures.
INVESTIGATOR SIGNATURE:
To the best of my knowledge, I certify that the information provided in this Animal Care and Use Protocol is
complete and accurate. I understand that approval must be renewed annually, that every third year the IACUC
must perform a new review of my protocol, and that I might be required to complete a newer version of the Animal
Care and Use Protocol and provide additional information at the time of the triennial review.
I also understand that IACUC approval must be obtained by an amendment to this protocol before I:
 Use additional animal species, increase the number of animals used, or increase the number of procedures
performed on individual animals;
 Change procedures in any way that might be considered a minor or significant departure from the written
protocol;
 Perform additional procedures not described in this Institutional Animal Care and Use Protocol;
 Allow other investigators to use these animals on other protocols, or use these animals on another of my
IACUC-approved protocols.
I further certify that:
 No personnel will perform any animal procedures until they have been approved by the IACUC;
 When new or additional personnel become involved in these studies, I will submit their qualifications,
training, and experience to the IACUC and seek IACUC approval before they are involved in animal studies;
 I will ensure that all personnel are aware of the institutional Occupational Health and Safety training prior
to their contact with animals. The Standard Operating Procedures for Biology
(http://www.jmu.edu/researchintegrity/iacuc/sops/index.shtml) or Standard Operating Procedures for the
College of Health and Behavioral Studies (https://www.jmu.edu/researchintegrity/iacuc/sopschbs/index.shtml) will fully explain the overall Occupational Health and Safety program and must be
delivered face-to-face or be declined in writing to participate.
 I will ensure that all personnel involved with the care of laboratory animals have received the proper onthe-job training in conjunction with the appropriate Standard Operating Procedures.
 I will provide my after-hours telephone numbers to the animal care staff in case of emergency.
Principal Investigator: In signing this document I am ensuring that I have considered alternatives to animal
models and alternatives to procedures that cause more than momentary pain or distress AND that I have paid
careful attention to the appropriate species, the number of animals, and procedures used. All procedures
involving animals will be performed under my direction. These activities do not unnecessarily duplicate
previous procedures.
Name (Printed)
Co-Principal Investigator
Signature
Date
Name (Printed)
Signature
Date
Department Chairperson’s Endorsement: I have reviewed the proposal which is the basis of this Animal Use
Protocol and endorse its submission.
Name (Printed)
Signature
Date
Attending Veterinarian: I have reviewed this protocol in the context of provisions of the Animal Welfare Act,
the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and
Training and other statutes and regulations relating to animals.
Name (Printed)
Signature
Date
When students are proposed in a protocol application, this certification must be obtained for all named
students.
By signing below, the Responsible Student Researcher certifies that he/she is familiar with the University’s IACUC
policy. He/she further certifies that he/she has completed training regarding animal care and use protocols
within the last three years and is familiar with the Standard Operating Procedures.
Student Researcher(s) Name
Signature of Student Researcher(s)
Date
Submit an electronic version (in a Word document) of your ENTIRE protocol to researchintegrity@jmu.edu.
Provide a SIGNED hard copy of the Animal Use Protocol (AUP) to:
Office of Research Integrity, MSC 5738
601 University Boulevard
Blue Ridge Hall, Third Floor, Room # 344