Protocol #:
Approval Date:
TNPRC Only
Projects:
Assigned Vet:
Census Code:
Institutional Animal Care & Use Committee
PROTOCOL for the Use of Live Nonhuman Vertebrates
(other than NHPs) in Research, Teaching or Demonstration
IACUC Office, 1430 Tulane Ave. TB 23 New Orleans, LA 70112 504-988-6868
TNPRC IACUC Office, 18703 Three Rivers Road, Covington La 70343 985-871-6636
Email a copy of this protocol to iacuc@tulane.edu
Date Filed:
Principal Investigator:
Division / Department:
E-mail:
http://tulane.edu/asvpr/iacuc/index.cfm
Position/Title:
Phone:
Lab Phone:
Address/Mailbox:
Co-investigator and/or Tulane contact:
Position/Title:
Division / Department:
Additional Contact Person(s):
Emergency Contact:
Phone:
(required if PI is an outside collaborator at the TNPRC)
E-mail:
Email:
Phone:
TITLE OF PROTOCOL:
List the Title of the grant only if it differs from the protocol title:
TYPE OF REVIEW: select one FUNDING AGENCY OR SOURCE:
PROJECT START DATE:
DURATION OF PROJECT:
- Please include animal use for the
duration of the entire study. While protocols are approved for three years the committee needs to review the complete
project.
TNPRC ONLY
IS THIS PROTOCOL A SUBCONTRACT OR FEE-FOR-SERVICE?
NO
YES (If the PI of the grant is affiliated with an institution other than TNPRC, “yes” should be indicated.)
IF YES, INDICATE PI OF THE GRANT:
INITIAL PROTOCOL –Proceed to Section III. Species
RENEWAL PROTOCOLS – List protocol number:
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Page 1 of 10
Start at Section I. A
SECTION I. RENEWAL PROTOCOLS ONLY
Please enter a brief summary of what has been accomplished thus far so that the continuation efforts described in
this protocol can be better understood. Please include any relevant publications from your study.

SECTION II. SPECIES, NUMBER & CATEGORY OF ANIMALS currently assigned to this project that will
continue on this project. http://tulane.edu/asvpr/iacuc/index.cfm for detailed description of each USDA category
SPECIES CURRENTLY ASSIGNED
STRAIN
NUMBER
*USDA
CATEGORY
.
.
.
.
.
.
.
.
.
.
.
.
COMMENT:
SECTION III. SPECIES, NUMBER & CATEGORY OF ANIMAL USE to be assigned
 Do not include animals listed in SECTION II.
SPECIES TO BE ASSIGNED
STRAIN
NUMBER
.
.
.
.
.
.
COMMENT:
*USDA
CATEGORY
.
.
.
.
.
.
IMPORTANT
All questions must be answered in order for the protocol to undergo IACUC review.
Do not refer to or attach passages from grants.
SECTION IV. REGULATORY INFORMATION
A. Please check YES or NO as it applies to the species requested. If you answer YES to a question, you must
provide an explanation and justification.
1. Is this an endangered or threatened species?
No
Yes
2. Is short-term (> 30 minutes; < 12 hours) physical restraint of a conscious animal employed?
No
Yes
3.
Is long-term (12 hours or more) physical restraint of a conscious animal employed?
No
Yes
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Page 2 of 10
4.
Will specialized management procedures be required, e.g. specialized caging equipment, restricted or altered
feeding/watering/sanitization schedules, or environmental parameters such as cage size, temperature, lighting
or other fall outside the “Guide for the Care and Use of Laboratory Animals”?
No
Yes
5.
Will you perform more than one major survival surgery on any animal? PLEASE NOTE: major survival
surgery penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic
functions (such as laparotomy, thoracotomy, craniotomy, joint replacement or limb amputation).
No
Yes
6.
Will animals be housed outside of AAALAC-accredited Tulane facilities for over 12 consecutive hours? If
YES, the proposed site must be inspected and approved by the IACUC prior to use. Please list the location
with justification below.
No
Yes
Please complete Appendix A http://tulane.edu/asvpr/iacuc/hsc/deadlines.cfm
7.
Will pain or distress without the use of analgesic or anesthetic agents occur during the course of
experimentation? This is Category E and must be scientifically justified with references.
No
Yes
8.
Will these procedures be filmed, videotaped or photographed for use outside the institution? If so, you must
obtain approval from the Executive Director of Comparative Medicine. (985-871-6285)
No
Yes
SECTION V. PERSONNEL HAZARDS
A. Is there potential exposure of humans to chemical hazards, physical hazards, radioactive agents, or
biohazardous agents during the course of animal experimentation?
No
Yes - please respond to the choices below.
1.
2.
3.
4.
Physical
Describe:
http://www.som.tulane.edu/oehs/
Chemical
Describe:
http://www.som.tulane.edu/oehs/
Radioactive
Describe:
http://www.som.tulane.edu/oehs/
Biohazard
Describe:
http://tulane.edu/asvpr/biosafety/index.cfm
Does this require IBC approval? http://tulane.edu/asvpr/biosafety/committee/index.cfm
YES - Proceed to Question B. below
NO
5.
Recombinant DNA Describe:
Proceed to Question B. below
B. Have you sought Institutional Biosafety Committee (IBC) review?
Yes, please provide the IBC#
Pending review
The above information in A. will be shared with the appropriate office.
SECTION VI. NON-TECHNICAL SUMMARY
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Page 3 of 10
Using non technical language (lay) that a layperson with no scientific background would understand, provide a
brief summary that describes the nature and purpose of the this study and its potential value to human or animal
health the advancement of knowledge or the betterment of society. Do not use scientific jargon, acronyms or
abbreviations and do not cut and paste from grant applications.

SECTION VII. COMPLETE DESCRIPTION OF ANIMAL USE
A. HYPOTHESES - Please state your hypotheses in this section but do not cut and paste passages from your
grant application. It is recommended that you limit this to approximately 20 lines.

B. DESCRIPTION - Provide a concise description including all steps, in chronological order, the experimental
course of an animal from its entry into the experiment to the endpoint of the study. It is recommended that you
provide a table or tables, which includes the Animal Group Composition, Sampling, Procedures, Drugs,
Compounds and Time points. Please provide a table title reference if using more than one table.

Insert table
C. STANDARD OPERATING PROCEDURES (SOPs)
Procedures may reference an approved TULANE SOP/Policy in lieu of a complete description. The dropdown
menus below list the most common procedures conducted. Please choose all of the SOPs that will be used on
your study. Some SOP/policies listed here are available at http://tulane.edu/asvpr/iacuc/hsc/sops.cfm. A table
of contents is available upon request to iacuc@tulane.edu.
If there is no approved SOP then a complete description must be included in the Concise Description (A.).
.
.
.
.
.
.
List any SOPs (# and title) that will be used but are not on the menu above:
D. PROPOSED TREATMENTS
ALLEVIATION OF PAIN AND DISTRESS: Describe the use of analgesics, anesthetics, and tranquilizing
drugs to minimize discomfort, distress, pain or injury. The list below contains some common drugs and doses and
must be checked if they will be administered in this protocol. Guidelines for Rodent & Rabbit Analgesia and
Tranquilization & Euthanasia Methods available at http://tulane.edu/asvpr/iacuc/hsc/sops.cfm
MOUSE AND RAT
DRUG
Preanesthetic
Atropine
Anesthetic Drugs
Ketamine/Xylazine
Pentobarbital
Isoflurane gas
Analgesic Drugs
Buprenorphine
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DOSE
ROUTE
FREQUENCY
0.05 mg/kg
IM/SC
Prior to anesthesia
80-110/5-10 mg/kg
50-80 mg/kg
1-5% in oxygen, to effect
IM/IP
IP
Inhalation
As needed
As needed
Continuous
0.05-0.1 mg/kg
IM/SC/IP
BID-TID
Page 4 of 10
Caroprofen
1-2 mg/kg
SC/PO
Meloxicam
5-10 mg/kg
SC/PO
Local anesthetics/analgesics (can be combined in same syringe)
Lidocaine
0.5%, maximum dose 7
SC/intramg/kg
incisional
Bupivicaine
0.25%, maximum dose 8
SC/intramg/kg
incisional
OTHER analgesics, anesthetics, and tranquilizing drugs that will be used:
BID
SID
Fast onset, but short duration (1 hour)
Slow onset, but long duration (4-8 hours)
RABBIT
DRUG
Preanesthetic Drugs
Glycopyrrolate
Sedative Drugs
Acepromazine/Buprenorphine
Ketamine/Diazepam
Anesthetic Drugs
Isoflurane gas
DOSE
ROUTE
FREQUENCY
0.01 mg/kg
IM/SQ
Prior to anesthesia
1/0.02 mg/kg
20-25/1-3 mg/kg
IM/SQ
IM/SQ
As needed
As needed
1-5% in oxygen, to
effect
20-35/1-3 mg/kg
Inhalation
Continuous
Ketamine/Xylazine
IM
Analgesic Drugs
Buprenorphine
0.01-0.05 mg/kg
IM/SQ
Meloxicam
0.1-0.2 mg/kg
IM/PO
OTHER analgesics, anesthetics, and tranquilizing drugs that will be used:
As needed
BID
Once daily
PIG
DRUG
Preanesthetic
Atropine
Anesthetic Drugs
TiletamineZolazepam/Xylazine
Pentobarbital
Isoflurane gas
DOSE
ROUTE
FREQUENCY
0.04 mg/kg
IM/SC
Prior to anesthesia
4-6/2-3 mg/kg
IM/IV
As needed
40-50 mg/kg
1-5% in oxygen, to
effect
IV
Inhalation
As needed
Continuous
Analgesic Drugs
Buprenorphine
0.05-0.1 mg/kg
IM
BID
Local anesthetics/analgesics (can be mixed and combined in same syringe)
Lidocaine
0.5%, maximum
SC/IT/intraFast onset, but short duration (1 hour)
dose 7 mg/kg
incisional
Bupivicaine
0.25%, maximum
SC/IT/intraSlow onset, but long duration (4-8 hours)
dose 8 mg/kg
incisional
OTHER analgesics, anesthetics, and tranquilizing drugs that will be used:
V10/26/09
Page 5 of 10
Species:
DRUG
DOSE
ROUTE
FREQUENCY
E. VETERINARY CARE
Routine care as specified in the standard operating procedures
 Division of Veterinary Medicine (985-871-6266) http://www.tnprc.tulane.edu/index.shtml
 Department of Comparative Medicine (504-988-5211) http://tulane.edu/asvpr/dcm/index.cfm
Special care. Provide a plan of action including phone numbers of essential personnel.

F. ADVERSE EFFECTS /CLINICAL ENDPOINTS
Please list any adverse effects or reactions that have been documented or could be expected from the use of the test
article (drug, antibody, other material) during the study. If none are expected, please state that.

Please list what treatment plan(s) will be employed in response to such should they be noted during the course of
this research.

G. ENDPOINTS
To review the Policy of Humane Experimental Endpoints in Rodent Research, please click on this link:
http://tulane.edu/asvpr/iacuc/hsc/sops.cfm
The Policy of Humane Experimental Endpoints in Rodent Research is acceptable for this study.
The endpoints for this study are time based and noted on the Experimental Design Section VII.B.
However, if an animal’s physical condition deteriorates the Policy of Humane Experimental Endpoints in
Rodent Research is acceptable for this study.

There is NO ENDPOINT to this study other than the approved study period and euthanasia is not required.
However, if an animal’s physical condition deteriorates the Policy of Humane Experimental Endpoints in
Rodent Research is acceptable for this study.

I choose not to use the Policy of Humane Experimental Endpoints in Rodent Research - Please list the
criteria to use to determine when euthanasia will be performed.

H. EUTHANASIA METHOD
Indicate the method to be used; include dosage and route of administration for each species indicated.

Is the method listed above consistent with the recommendation of the AVMA Guidelines on Euthanasia?
http://www.avma.org/issues/animal_welfare/euthanasia.pdf
V10/26/09
Page 6 of 10
YES, the method listed above is consistent with the recommendation of the AVMA Guidelines on
Euthanasia.
NO, it is not consistent. Please provide justification (supported with references) for not following the
recommendation:
SECTION VIII. ANIMAL USE JUSTIFICATION
A. RATIONALE FOR ANIMAL USE. It must include the reasons why non-animal models cannot be used.

B. APPROPRIATENESS OF THE SPECIES SELECTED (Please address if preliminary studies have been
conducted using other species or lower life forms.)

C. ANIMAL NUMBER JUSTIFICATION
Please identify the approaches listed below used to justify the number of proposed animals for this study and
provide an explanation. More than one justification may be necessary for renewal protocols.
Citation of previous research, with sufficient information provided to indicate that the previous research is
similar enough in concept and methodology to make it reasonable to use similar sample sizes in the
proposed research project.
Explanation
Statistical analysis- if numbers are chosen with the intent of obtaining statistically significant differences,
the most objective tool is usually a power analysis to determine sample size. When groups are compared,
the goal of conducting a power analysis is to determine the appropriate number of animals per group to
ensure detection of a significant difference. Please use the attached link for an example of the information
needed to review a power analysis.
Explanation
Pilot study- the following information must be included:
 Main outcome measure being evaluated (e.g. reduction in tumor size)
 The definition of success (e.g., a 50% reduction in tumor size in 3 animals) that would indicate
that the study should be followed up by a full study.
Explanation

Is your study a Category D or E?
No - Proceed to Section X.
Yes - Please complete Section IX
SECTION IX. ALTERNATIVES TO PAINFUL AND DISTRESSFUL PROCEDURES
As required by Policy 12 of the Animal Welfare Act, “the IACUC is required to assure that the principal
investigator has considered alternatives to procedures that may cause more than momentary or slight pain or
distress” and “that the PI has provided a written narrative description of the methods and sources, such as the
Animal Welfare Information Center, Biological Abstracts, Index Medicus, PubMed, and the Current Research
Information Service.”
V10/26/09
Page 7 of 10
Alternatives are defined as new methods that refine existing usage by minimizing animals’ distress such as the
use of analgesics, reduce animal usage such as the use of certain experimental designs, or replace whole animal
tests with other procedures such as the use of in vitro analyses.
Database
Used
Date of
search
Period
covered by
search
Keywords used
Number of
relevant
references
Were
alternatives
found
If alternatives were found, justify why they are not being used.

Additional relevant sources may include scientific meetings, scientific discussion, consultation with veterinary
staff and federal law or other legal guidelines. Please list below.

SECTION X. ENVIRONMENTAL ENHANCEMENT
Tulane University houses all rodents, guinea pigs and rabbits according to Tulane standard operating procedures
(SOPs). In addition, all animals are group housed, when compatible, and provided with various nesting materials
and/or cage manipulanda, when appropriate. If you need additional information concerning the housing of small
animal species at Tulane contact:
DCM Downtown – 504-988-5211
TNPRC - Contact the Small Animal Veterinarian at 985-871-6496 and/or Small Animal Supervisor at 985-8716348
A. SELECT ONE HOUSING CATEGORY PER SPECIES
SPECIES
.
.
.
.
HOUSING
.
.
.
.
EXPLANTION / *JUSTIFICATION
B. SELECT ONE ENRICHMENT CATEGORY PER SPECIES
Standard Enrichment – Enrichment Policy is available at http://tulane.edu/asvpr/iacuc/hsc/sops.cfm
Specific Enrichment required for the proposed study. You must provide specific instructions for the type of
enrichment required:
Mice
Nesting Material
Rubber toys
Balls
Feed supplements
Hides/Tunnels
Other Species:
Rat
Nesting Material
Rubber toys
Balls
Feed supplements
Hides/Tunnels
Specify Enrichment:
Ferret
Nesting Material
Chew toys
Balls
Feed supplements
Hides/Tunnels
Restricted Enrichment required for proposed study
Please provide the specific restrictions and provide a justification:
V10/26/09
Page 8 of 10
Rabbit
Balls
Dumbbells
Feed supplements
Nesting material
Group Housing
SECTION XI. PERSONNEL
Provide a listing of all personnel who will have direct contact with animals involved with the proposed
experimentation. Do not list veterinary medicine staff involved with the daily husbandry. You must list each
person’s role on the project. All individuals must be appropriately qualified and trained in the proposed animal
care and use.
NAME/ TITLE
SPECIFIC ROLE ON PROJECT -i.e.
surgery, tissue collection, euthanasia,
consult
TRAINING - List training for role or indicate that
additional training is needed.
Outside Persons who will conduct procedures Persons who will conduct any procedure on-site must have
completed the training and occupational health programs. All persons involved must complete the required
training prior to the start of the project.
DCM Downtown – 504-988-5211
TNPRC - Please contact the Occupational Nurse at 985-871-6596 to complete the necessary forms.
NAME/
TITLE
AFFLIATION
SPECIFIC ROLE ON PROJECT
-i.e. surgery, tissue collection,
euthanasia,
TRAINING - List training for role or
indicate that additional training is needed.
RISK ASSESSMENT AND HISTORY FORM (RAHF): All faculty, staff, and students who handle animals as
a part of this protocol must participate in the Animal Handlers Health Surveillance Program to include the
completion of the RAHF and the application of medical follow up as needed. For information or copies of these
forms, please contact:
Office of Environmental Health and Safety via email oehsrahf@tulane.edu or by telephone, 988-5486 (press 1)
TNPRC staff only - contact the Occupational Nurse at 985-871-6596
Access the form at http://www.som.tulane.edu/oehs/docs/26F-oehss20.pdf
SECTION XII. FACILITIES
List all extra-vivarial rooms used for animal experimentation, demonstration or housing (if animals are kept
longer than 12 hours the room must be approved by IACUC prior to use).
BUILDING
V10/26/09
ROOM NUMBER
USE
Page 9 of 10
SECTION XII. PRINCIPAL INVESTIGATOR CERTIFICATIONS
1.
2.
3.
4.
5.
6.
7.
8.
I certify that the animal care and use described in this protocol is exactly as described in the funding
application (if applicable) for this protocol.
I certify that I have determined that the research proposed herein is not unnecessarily duplicative of
previously reported research.
I certify that all individuals working on this protocol are participating in the Tulane University
Occupational Health and Safety Program.
I certify that the individuals listed in Personnel, if noted to do animal work, are authorized to conduct
procedures involving animals under this proposal, have received training in: the biology, handling, and care
of this species: aseptic surgical methods and techniques (if necessary): the concept, availability, and use of
research or testing methods that limit the use of animals or minimize distress: the proper use of anesthetics,
analgesic, and tranquilizers (if necessary): and procedures for reporting animal welfare concerns.
For all USDA Classification D and E protocols I certify that I have reviewed the pertinent scientific
literature and have found no valid alternative to any procedures described herein which may cause more
than momentary pain or distress, whether it is relieved or not.
I certify that I will obtain approval from the IACUC before initiating any changes in this study.
I certify that I will notify the IACUC regarding any unexpected study results that impact the animals. Any
unanticipated pain or distress, morbidity, or mortality will be reported to the attending veterinarian and the
IACUC.
I certify that I am familiar with and will comply with all pertinent institutional, state, and federal rules and
policies.
I have read the assurances and I understand that failure to comply with these assurances may result in suspension
or termination of this animal activity and the filing of a report of non-compliance with this Institution’s IO and
appropriate governing agencies.
Principal Investigator
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