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VILLANOVA UNIVERSITY
Institutional Animal Care and Use Committee
Animal Use Protocol for Instructional Courses
I. INTRODUCTION
The Villanova Institutional Animal Care and Use Committee (IACUC) has long directed efforts
toward the assurance of humane animal care serving, essentially, as the research ethics board
committed to animal welfare at this institution. As intermediary between science and the public,
the IACUC must judge the merit of proposed animal research and enforce regulations set forth in
the Animal Welfare Act (AWA) and in accordance with the guidelines stated in the Public
Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals. Such endeavors
have primarily affected research programs in which animal utilization is considered necessary.
However, educational programs at this academic institution also entail the utilization of animals
for instructional purposes in undergraduate and graduate courses. In order to ensure appropriate
treatment of all animals used at Villanova, the IACUC mandated submission of protocols for the
utilization of all vertebrate animals in teaching effective January 1, 2002. Implementation of this
procedural change reflects anticipated modifications in animal welfare regulations and,
improvement of IACUC assessment of animal use issues at Villanova.
In light of the diverse areas of science in which animal utilization may occur, in this
document, the term "animal" is defined as any vertebrate animal including typical laboratory
animals housed in on-site facilities, wildlife, and aquatic animals. In addition, the term
"utilization" refers to any procedure in which animals are handled or manipulated in invasive or
non-invasive techniques. Field investigations that involve only visual observations in
unobtrusive manners and the use of archived materials (e.g., museum specimen collections) do
not require protocol submission. Outside of these exceptions, in courses that utilize animals the
following critical issues need to be addressed in accordance with guidelines published in the NIH
Guide for the Care and Use of Laboratory Animals, the AWA, and by the USDA (Animal
Welfare Regulations: Title 9 Code of Federal Regulations):
1. Assure compliance with standards of care for live animals. Animals used for
instructional purposes must receive the same humane care and treatment as those used for
research purposes. This necessitates proper instruction, training, and supervision of
students.
2. Clear and well publicized policies pertaining to the utilization of animals in teaching.
Dissemination of this information to prospective students by course instructors and
faculty advisors across colleges is essential to ensure appropriate treatment of animals
and avoid any misunderstanding among students about the use of animals in Villanova
courses. Within individual courses an approved departmental statement on animal use or,
supporting literature from government or other research agencies should be distributed on
the first day of class. Faculty must have in place a mechanism by which they ensure each
student has read and/or heard this information and, clearly understands the policies
therein.
3. Assure the occupational health and safety of personnel/students. Measures must be
taken to assess potential risks involved in procedures or exercises in which animals are
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utilized. If necessary, additional training should be given to protect those individuals
working with animals in a laboratory or field setting.
4. Search for alternatives to use of animals. Can educational objectives be met by other
means? When learning objectives cannot be met by replacement with non-animal models
(e.g. mathematical or computer) or in vitro models (e.g. tissue culture) or are better
facilitated by the utilization of animals, it is important that effective animal use be
assured through careful planning of laboratory procedures. Instructors must refine animal
utilization procedures to limit potential pain and distress and minimize the number of
animals to the greatest extent possible without compromising educational goals.
IACUC review and approval of animal protocols for instructional courses will ensure that these
criteria are met and consequently assure protection of teaching faculty. Faculty may access the
Office of Laboratory Animal Welfare (OLAW: www.grants.nih.gov/grants/olaw), the Animal
Welfare Information Center (AWIC: www.nal.usda.gov/awic), or the United States Department
of Agriculture (USDA: www.aphis.usda.gov/ac) for helpful information when completing
protocol forms. In addition, a copy of the NIH Guide for the Care and Use of Laboratory
Animals may be borrowed from the department offices in Biology (Mendel 147) or Psychology
(Tolentine 334) as an information resource.
II. GENERAL INSTRUCTIONS
1. Protocol submission is REQUIRED for all courses using vertebrate animals or 18 day or older
chick embryos.
2. Procedural protocols may be submitted by primary faculty which upon approval, become
"blanket" protocols receiving an IACUC referral number. These protocols may cover various
courses in which the same approved procedures are used. When a course is utilizing a preapproved blanket protocol, faculty must cite the specific IACUC referral code in their course
protocol forms. Use of blanket protocols will obviate the need to submit separate forms for
procedures that are shared between courses and therefore limit unnecessary work.
3. Course protocols should reflect expected animal usage according to prior enrollment patterns
and lab procedures. Approved protocols are good for a maximum of three years. Significant
deviations in animal procedures, animal species, or animal numbers as well as a change in
the primary faculty within that period of time will require submission and review of a new
protocol.
4. When planning of animal procedures in advance may not be appropriate, as with graduate
level experiment-based courses in which mini research projects are developed during the
semester, interim protocols may be submitted. Such interim protocols should be submitted as
soon as possible upon planning of the research project and as far in advance as possible of
the planned animal procedures. In the case of student directed in-course projects, faculty
should encourage their students to complete a protocol form as part of the experimental
process. Measures will be taken by the IACUC to address such interim protocols with
appropriate justification as to why advanced approval was not possible.
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III. DEADLINES
To ensure review of animal protocols in advance of the start of classes each semester, please
submit protocols in accordance with the following deadlines:
May 15 for summer session courses
August 15 for fall semester courses
December 10 for spring semester courses
Adherence to submission deadlines is essential. Faculty members who submit protocols on time
will be notified of the IACUC decision prior to the beginning of classes. The IACUC cannot
guarantee review of late protocols (submitted after the deadline) in advance of the planned
procedures in that course. Such delay will put faculty at risk of noncompliance and may result in
IACUC intervention in animal procurement, access, and usage in that course.
IV. SUBMISSION
Protocols are to be submitted by campus mail to the IACUC chair at the address listed below or
by E-mail as an MSWord file attachment. In the case of E-mail submission, the instructor is
asked to send a print copy of the approval page with their signature by campus mail to the
IACUC chair. Faculty will receive a hard copy of the protocol for their files upon approval.
Dr. Louise Russo
Department of Biology
Email: louise.russo@villanova.edu
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For IACUC use only
VILLANOVA UNIVERSITY
INSTITUTIONAL ANIMAL CARE and USE COMMITTEE
ANIMAL USE PROTOCOL FOR TEACHING
(VERTEBRATES ONLY)
(REVISED January 2014)
INSTRUCTIONS: Please read carefully
This form is to be completed and submitted to the Chair of the Institutional Animal Care and Use
Committee (IACUC) by all faculty who use vertebrate animals in their courses for teaching purposes.
The completed protocol should describe all animal procedures and must adhere to the standards and
requirements as stated in the NIH Guide for the Care and Use of Laboratory Animals. The names of all
faculty who will be using animals under the submitted protocol must be kept on file by the principal
instructor. If you have any questions about completing the protocol, please contact the IACUC chair
at 610-519-4869 or by E-mail (louise.russo@villanova.edu).
When approved, a copy of this protocol will be returned to the principal instructor. If the protocol is
undertaken, it will become a public document. Any significant changes to an approved protocol
regarding teaching procedures, faculty, or types and numbers of animals must be submitted for additional
review and approval.
THIS FORM MUST BE TYPED
1. PROTOCOL/EXPERIMENT TITLE (required):
2. PRINCIPAL INSTRUCTOR(s) and CAMPUS ADDRESS
Name
Campus Telephone
3. ESTIMATED DATES OF PROTOCOL: From
to
Campus E-mail
(not to exceed 3 years)
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4. ACADEMIC DEPARTMENT and COURSE (include course number) IN WHICH PROTOCOL WILL
BE USED
5. PROVIDE A NON-TECHNICAL STATEMENT/DESCRIPTION of the GOALS OF THE STUDENT
LABORATORY for which ANIMALS are to be USED. Describe anticipated educational benefits (should
be written for a lay person’s/ non-scientist’s understanding):
NOTE: ITEMS 6 through 13 MUST be completed by instructors incorporating use of live
animals in their laboratory exercises.
For laboratory procedures that require use of preserved specimens ONLY, continue protocol
at item #14.
6. SUPERVISOR IN CHARGE OF ANIMAL COLONY
In cases where live animals are to be housed and maintained for extended periods of time in Villanova
vivaria, identify the individual who will be responsible for oversight of the animal colony (to check boxes
in Word, double click on the appropriate box and select “checked” from the option list):
Departmental Animal Caretaker, please identify:
Faculty member submitting this protocol
Student, please identify:
Animals will not be housed in Villanova facilities, SKIP to item #9
7. PERSON(s) WHO WILL PROVIDE PRIMARY ANIMAL CARE if different than the individual
indicated in item #6.
8. EMERGENCY CONTACT IF PRINCIPAL INSTRUCTOR IS ABSENT
Name(s)
Phone (s)
9. PROCEDURES TO BE USED
Describe all laboratory or field investigation procedures to be performed utilizing animals. Differentiate
between species. For field investigations that involve capture and manipulation of animals, describe methods of
acquisition, the type of invasive or non-invasive manipulation that is planned, and the final disposition of
captured specimens. For surgical procedures involving recovery, methods of anesthesia including drug
compounds, dosages and routes of administration, and post-operative care must be described. If you are using
only procedures covered by a previously approved "Blanket" Protocol, identify that protocol by reference
number in the space below and Skip to Item #14.
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NOTE: federal guidelines now specifically stipulate that if animals are to be administered drugs/chemical
agents, formulations must include pharmaceutical-grade compounds (PGCs) for both veterinary and research
applications. However, investigators may request an exception to this mandate based upon acceptable scientific
justifications for the use of non-PGCs. Please refer to Appendix B to this protocol which includes a summary
of the Guidelines for the Use of Non-Pharmaceutical Grade Compounds in Laboratory Animals. Within your
experimental procedure narrative, you MUST include specific information for each treatment compound as to
whether it is a PGC or non-PGC compound in addition to source information (supplier/place of purchase). If
you expect to use a non-PGC in your protocol, you MUST include specific scientific reasoning for that
option in your experimental procedures for IACUC review. Use information outlined in the Guidelines for
the Use of Non-Pharmaceutical Grade Compounds in Laboratory Animals (Appendix B) for support of your
request making clear why you cannot use a PGC compound for the protocol.
10. SELECT APPLICABLE STATEMENT REGARDING PAIN and DISTRESS. Unless the contrary is
established, faculty should consider procedures that would cause pain and distress in humans likely to
cause pain and distress in animals. Refer to Appendix A for categories of animals based upon pain and
distress level.
Pain and/or distress will not be induced by the described procedures
Some level of distress will be induced ; pain will not be induced
Pain and/or distress will occur; pain will be relieved by drugs listed below as appropriate:
ANIMAL SPECIES
(Genus species)
DRUG
DOSE
ROUTE
If drug intervention would interfere with the protocol, clearly describe the reasons why.
If pain and/or distress are induced during the laboratory procedure an alternative procedure(s) must be
considered.
No alternative is acceptable. Reference source:
An alternative is available but will not be used, explain:
11. If this procedure may cause more than momentary or slight pain or distress to the animals, by law you
must consider an alternative. These alternatives include a less stressful procedure, replacing the species selected
with one believed to be less likely to suffer from the procedure, and reducing the number of animals you are
requesting. Please indicate the source(s) you examined for the alternatives and answer the following questions.
Animal Welfare Information Center (AWIC)
Current Research Information Center (CRIC)
PsychInfo
Literature Search
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Biological Abstracts
Other (Please specify)
The USDA and NIH require the following information: date of Literature Search
Years covered in the literature search: from
to
Key words used in literature search:
12. If SURVIVAL SURGERY IS REQUIRED, IN WHICH ROOM(s) WILL SURGERY AND POSTOPERATIVE CARE BE PERFORMED?
13. PROPOSED EUTHANASIA TECHNIQUES
List by species and technique, including drug type, dose, and route of administration where applicable
ANIMAL SPECIES
MODE of EUTHANASIA
What criteria will the investigator use to assure that death has occurred (be very specific i.e.
cessation of respiration/heart beat, exsanguination, etc.)?
14. ANIMAL INVENTORY AND FACILITIES
Indicate the species and animal numbers likely to be used in described procedures as well as the room
location(s) where they will be stored or housed if applicable. NOTE: Prior approval must be obtained
from the IACUC if live animals are to be kept for more than 12 hours at sites other than those listed
below.
Field investigation only, animals will not be housed in Villanova facilities
Preserved specimens will be used, storage locations indicated
Live animals will be used, housing locations indicated
ANIMAL SPECIES
NUMBER
to be
USED
LOCATION WHERE
STORED/HOUSED
Include building and room numbers
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15. PROPOSED SOURCE(s) OF ACQUIRED ANIMALS. For live animals indicate supplier. For preserved
specimens indicate vendor(s) from which materials are obtained.
16. JUSTIFY THE NUMBER OF ANIMALS AND SPECIES THAT WILL BE USED IN THE COURSE.
Base this number on anticipated enrollments reflective of course history and laboratory design. Please
explain.
17. IS THERE AN ALTERNATIVE TO THE USE OF ANIMALS FOR THIS EDUCATIONAL PURPOSE?
No, explain :
Yes, explain why alternative is not being used:
18. DISPOSITION OF ANIMAL REMAINS:
Provide specific information on where (building and room number) and under what conditions animal remains
are to be stored until processed for disposal. If remains are processed through the contracted Villanova
biohazardous waste contractor (Browning Ferris Industries) simply indicate standard handling procedure. If
other arrangements are made, indicate specific information regarding handling of remains and final method of
disposal.
19. WHAT MEASURES WILL BE TAKEN TO INFORM STUDENTS OF A DEPARTMENTAL OR
COURSE SPECIFIC ANIMAL USE POLICY (e.g. statement in syllabus, handout, training session, etc.)
AND WHAT STEP(S) WILL BE TAKEN TO ENSURE STUDENT UNDERSTANDING AND
AGREEMENT WITH THE STATED POLICY?
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20. APPROVAL
I have determined that students, staff, and/or faculty who carry out the procedures described herein are qualified
to complete these tasks in a humane and scientifically acceptable manner.
Date
Signature of Principal Investigator (PI)
Name and Title of PI (Type or Print Clearly)
COMMENTS BY CAMPUS VETERINARIAN
APPROVED BY CAMPUS VETERINARIAN
Date
Signature of Veterinarian
APPROVED BY ANIMAL CARE COMMITTEE
Date
Signature of IACUC Chair
CATEGORY OF ANIMALS APPROVED FOR USE: (to be completed by the IACUC)
A
B
C
D
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Appendix A
CATEGORIES of ANIMAL USE ACCORDING to the LEVEL of INDUCED
PAIN & DISTRESS
Category A. Studies on live, vertebrate animals causing little or no pain or distress. These include:
housing and restraining animals for observation or examination, blood sampling, injection of nontoxic materials.
Category B. Studies involving some pain or distress of short duration. These include cannulation of
vessels or body cavities performed under anesthesia, minor surgical procedures under anesthesia
such as biopsies, overnight food or water deprivation, behavioral studies on awake animals that
involve short-term restraint. Studies on anesthetized animals that do not regain consciousness are
included in this category.
Category C. Studies using animals involving moderate to severe pain or stress or the potential for
moderate to severe pain/stress. These include major surgical procedures under anesthesia,
permitting recovery with adherence to acceptable veterinary practices, i.e. post-op analgesia, fluid
therapy and required veterinary nursing care. Animals should not show signs of prolonged clinical
distress such as behavioral abnormalities, dehydration, abnormal vocalization, or infections. Should
these clinical abnormalities develop and cannot be alleviated, the animals must be euthanized with
minimal delay.
Category D. Projects that involve significant stress or pain without the benefit of pain-relieving
drugs or appropriate therapy. Such studies include: application of noxious stimuli from which
escape is impossible, exposure to noxious stimuli or agents whose effects are unknown, footpad or
intradermal injections of Freund=s complete adjuvant, the use of euthanasia methods not approved
by AVMA. These projects are considered by some to be highly questionable or unacceptable
irrespective of the significance of the results. It is the explicit responsibility of the investigator to
explore alternative methods before proceeding with such studies. Veterinary involvement in these
studies is essential.
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Appendix B
Guidelines for the Use of Non-Pharmaceutical Grade Compounds in
Laboratory Animals
Reference: http://oacu.od.nih.gov/ARAC/documents/Pharmaceutical_Compounds.pdf
Investigators are expected to use pharmaceutical grade compounds whenever possible. The
Guidelines presented here are a synthesis of the requirements and expectations for the use of nonpharmaceutical grade compounds when they are necessary. This document references the
regulations, policies, and guidelines of the major animal research oversight organizations.1-4
Definitions:
Pharmaceutical-grade compound: A pharmaceutical-grade compound (PGC) is defined as any
active or inactive drug, biologic or reagent, for which a chemical purity standard has been
established by a recognized national or regional pharmacopeia (e.g., the U.S. Pharmacopeia (USP),
British Pharmacopeia (BP), National Formulary (NF), European Pharmacopoeia (EP), Japanese
Pharmacopeia (JP), etc.). These standards are used by manufacturers to help ensure the products
are of the appropriate chemical purity and quality, in the appropriate solution or compound, to
ensure stability, safety, and efficacy. 2 The Food and Drug Administration (FDA) maintains a
database listing of FDA approved commercial formulations for both FDA approved human drugs
(the Orange Book) and veterinary drugs (the Green Book).
Availability: Refers to compounds that are commercially available from an active U.S. vendor. Note:
OLAW has stated that the exorbitant cost of Nembutal (pentobarbital 50 mg/ml injection) has
placed it logistically into the unavailable category. 4
New investigational compound: A compound supplied by its manufacturer for testing in an
experimental setting only and for this reason would not have chemical purity standards established
and by default is considered a non-pharmaceutical grade compound (Non-PGC).
Requirements:
When compounds are used for the clinical treatment of animals or to prevent or reduce/eliminate
animal pain or distress PGCs must be used whenever possible.2
When compounds are used to accomplish the scientific aims of the study PGCs are preferred if
available and suitable. 2
The use of Non-PGCs in laboratory animals must be described and justified in the animal use
protocol and/or covered by an IACUC policy developed for their use and approved by the IACUC.
The AAALAC states that the investigator and the IACUC should consider the following factors when
using Non-PGCs2 :
 The provided scientific justification such as:
 A PGC is not available; this includes new investigational compounds.
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 A PGC is not available in the appropriate concentration or formulation or the
appropriate vehicle control is unavailable
 The Non-PGC is required to generate data that are part of an ongoing study or to
generate data that are comparable to previous work
• Whether the chemical properties of the compound are appropriate for the study (e.g., the
purity, grade, stability in and out of solution, solution vehicle properties, pH, osmolality, and
compatibility of the solvent and other components of final preparation) and the route of
administration.
• The method of preparation, labeling (preparation and use-by dates), administration and
storage of formulations should be appropriately considered with the aim of maintaining
their stability and quality;
• Use must be compliant with applicable national or regional regulatory guidelines and
requirements and the requirements of relevant funding agencies.
The last three factors are not specific to Non-PGCs and therefore should be considered by the ACUC
in general terms as is done for all pharmaceuticals and reagents and will only be considered further
in this guideline briefly.
Although the potential animal welfare consequences of complications are less evident in nonsurvival studies, the scientific issues remain the same as in survival studies and therefore apply to
non-survival studies. The use of a non-pharmaceutical-grade euthanasia agent must meet the same
standards as for use in any other application.3
The guidelines pertain to all components, both active and inactive, contained in the preparation to
be administered. Therefore, the vehicle used to facilitate administration of a compound is as
important of a consideration as the active compound in the preparation. Veterinary and human
drugs that are reconstituted in a manner not in accord with the product insert are considered NonPGCs.
Recommendations for use of non-pharmaceutical-grade compounds:
Where the use of Non-PGCs may be essential for the conduct of science, the goal of the ACUC
should be to consider the health and well-being of the animals while aiding the researcher in
minimizing potentially confounding experimental variables and maximizing reproducibility of the
research.2
As stated by OLAW, this Guideline suggests that the IACUC, in making its evaluation may consider
factors including, for example grade, purity, sterility, acid-base balance, pyrogenicity, osmolality,
stability, site and route of administration, compatibility of components, side effects and adverse
reactions, storage, and pharmacokinetics.3 As these considerations should be made for
pharmaceuticals and reagents of all kinds, this guidance from OLAW is generally applicable.
When selecting compounds the following order of choice should be applied:
1. FDA approved veterinary or human pharmaceutical compounds;
2. FDA approved veterinary or human pharmaceutical compounds used to compound a needed
dosage form;
3. USP/NF, BP, or other pharmacopeia recognized PGCs used in a needed dosage form;
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4. Analytical grade bulk chemical used to compound a needed dosage form (requires
justification);
5. Other grades and sources of compounds (requires justification).
The NIH Veterinary Pharmacist can provide assistance in availability, procurement, and formulation
of various PGCs.
The IACUC may use a variety of administrative methods to review and approve the use of such
agents. For example, the IACUC may establish acceptable scientific criteria within the institution,
rather than on a case-by-case basis. Investigators and IACUCs should consider relevant animal
welfare and scientific issues including safety, efficacy, availability of PGCs, and the inadvertent
introduction of new variables.3 With the exception of pentobarbital4, and presumably any other
comparable situations, cost savings alone is not an adequate justification for the use of Non-PGCs.
Acceptable scientific justifications for the use of non-pharmaceutical-grade compounds:4
1. No equivalent veterinary or human drug is available for experimental use. The highest-grade
equivalent chemical reagent should be used and formulated aseptically, with a non-toxic
vehicle, as appropriate for the route of administration.
2. Although an equivalent veterinary or human drug is available for experimental use, the
chemical grade reagent might be required to replicate methods from previous studies if it is
the only option to produce results that are directly comparable.
3. Although an equivalent veterinary or human drug is available, dilution or change in
formulation is required.
• If the formulation as provided must be diluted, altered by addition, or otherwise changed,
there may be no additional advantage to be gained by using the USP formulation.
• In this situation, use of the highest grade reagent may have the advantage of single-stage
formulation and also result in purity that is equal to or higher than the human or
veterinary drug.
• Professional judgment should be used to determine the appropriate test material and to
ensure use of an agent with the least likelihood for causing adverse effects.
4. The available human or veterinary drug is not concentrated enough to meet experimental
requirements.
5. The available human or veterinary drug does not meet the non-toxic vehicle requirements for
the specified route of administration.
References:
1
U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care, Policy 3Veterinary Care, March 25, 2011.
2 AAALAC Frequently asked questions about Non-Pharmaceutical Grade Compounds
3 OLAW Position Statement- Non-Pharmaceutical Grade Substances
4 Transcript of OLAW On-line Seminar broadcast on March 1, 2012 - Use of Non-PharmaceuticalGrade Chemicals and Other Substances in Research with Animals
Approved – 12/03/2008
Revised – 12/08/2010; 04/10/13