PROTOCOL FORM
USE OF LIVING, VERTEBRATE ANIMALS
Institutional Animal Care and Use Committee
Texas Woman’s University
Submit one hard copy and one electronic version to the IACUC secretary in the Office of Research and
Sponsored Programs (ORSP) at least 10 working days prior to the date of the next IACUC meeting.
PROJECT TITLE:
INVESTIGATORS: (List all investigators involved with the protocol and signify Principal Investigator with
an asterisk*)
DEPT. (Principal Investigator):
DEPT. PHONE:
EMAIL ADDRESS (Principal Investigator):
PROPOSED DURATION OF PROJECT: (M/D/Y)
to
From
FUNDING OR PROPOSED FUNDING SOURCE:
PROTOCOL NUMBER:
(if application is other than a new proposal or pilot project)
PROJECT CLASSIFICATION: (Check any that apply.)
A. Grant Proposal (External Source)
Identify Source
C.
D.
E.
F.
B. Grant Proposal (Internal Source)
Identify Source
New Proposal or Pilot Project
Triennial Review of Funded Project
Thesis/Dissertation Project
Course
Breeding Colony
Other (Explain)
PEER REVIEWER
Modification of Ongoing Project
Project Supplement
PEER REVIEWER (Signature)
(Print)
(Attach letter or email if reviewer is at another institution)
IACUC REVIEW (for committee use only)
Protocol Number: ____________
Date Protocol Application was Received by IACUC: (M/D/Y)
_____ Approved
_____ Modifications required for approval
_____ Disapproved
Other Comments:
Additional Review Required: _____No _____Yes (If yes, check all that apply.)
_____Radiation Safety Committee _____Institutional Biosafety Committee
IACUC Approval _____________________________ Date____________________
(IACUC Chair’s Signature)
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OTHER REVIEW
(For Committee Use Only)
Date received by Radiation Safety/Biosafety Committee:________________________
(Please specify committee.)
Committee Action:
_____ Approved
_____ Modifications required for approval
_____ Disapproved
Other Comments:__________________________________________________________________
Radiation Safety Committee Approval: ______________________________ Date: ____________
Institutional Biosafety Committee Approval: _________________________ Date: ____________
(Committee Chair’s Signature)
LAY STATEMENT
In a paragraph or two, describe the purpose of this study and explain how it will contribute to
“the greater good” of society. Your narrative MUST be written so that it can be understood by
someone who is NOT associated with scientific research.
BE SURE TO INCLUDE:
 a statement about the project goal(s)
 a description of potential benefits of the project
 a statement that mentions all of the species to be used and their importance to the project
 a statement about why an animal model is necessary.
Type lay statement here
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I. IACUC REVIEW CATEGORIES FOR ANIMAL EXPERIMENTS:
For each group of animals included in your study, indicate the number of animals per group and
whether pain or distress is associated with a given procedure. (Check all that apply.)
A.
Animals will suffer no pain or distress greater than that produced by routine injections or
venipuncture, and therefore, will receive no anesthetics, analgesics, or tranquilizers.
Animal Group
Control
Experimental
Teaching/training
B.
Number of Groups
Animals per Group
Animals will suffer no pain or distress because they will receive anesthetics, analgesics,
and/or tranquilizers.
Animal Group
Control
Experimental
Teaching/training
Number of Groups
Animals per Group
If surgery is performed, indicate the category:
1. Survival Surgery
Animal Group
Control
Experimental
Teaching/training
Number of Groups
Animals per Group
Number of Groups
Animals per Group
2. Non-Survival Surgery
Animal Group
Control
Experimental
Teaching/training
C. (1) Animals will experience pain or distress greater than that produced by routine injections,
or venipuncture and will NOT receive anesthetics, analgesics, or tranquilizers since this
will adversely affect the study.
.
Animal Group
Control
Experimental
Teaching/training
October 2014
Number of Groups
3
Animals per Group
If surgery is performed, indicate the category.
1. Survival Surgery
Animal Group
Control
Experimental
Teaching/training
Number of Groups
Animals per Group
Number of Groups
Animals per Group
2. Non-Survival Surgery
Animal Group
Control
Experimental
Teaching/training
C. (2) Interventions for pain or distress can ONLY be withheld when scientifically justifiable.
Interventions may be needed for painful study procedures or for accidental injuries or
infections. Specify below which interventions can and cannot be given.
a.
In the event that pain/distress occurs that is not a measurable outcome of
experimental manipulation, what interventions will be given?
analgesia
b.
other
None
What interventions are to be withheld?
analgesia
c.
euthanasia
euthanasia
other
none
If interventions are withheld, provide a brief explanation below as to why
intervention is inappropriate and explain more fully in item # (identity number to
be determined after revision is complete)
C. (3) Explain below what pain/distress assessments will be made and what criteria will be
used to terminate the experiment and/or provide appropriate anesthesia, analgesia or
euthanasia.
C. (4) Describe pre- and post-procedural provisions to assure that pain/distress/discomfort is
the minimum allowable without compromising scientific objectives.
D. (1) Animals will be treated with toxic or potentially toxic compounds.
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Animal Group
Control
Experimental
Teaching/training
Number of Groups
Animals per Group
D. (2) Are there potential hazards to personnel?
Yes
No
(Check each applicable hazard; if any are answered yes, proceed to D (3) below)
Radioisotope (
Carcinogen (
Biohazard (
Other (
)
)
)
)
D. (3) The Safety Officer or Risk Management must be consulted for radioactive and
carcinogenic materials. The Biosafety officer must be consulted for biohazards before
approval of the protocol. If compound is of unknown, but potential, hazard to personnel,
both offices MUST be consulted.
Who did you consult with and on what date? Please provide any written
correspondence concerning consultation.
Name of official(s) consulted:
Date(s) of consultation:
What precautions were recommended (please be specific)
D. (4) Explain below what pain/distress/discomfort assessments will be made and what criteria
will be used to terminate the experiment and/or provide appropriate anesthesia,
analgesia or euthanasia.
D. (5) Describe pre- and post-procedural provisions to assure that pain/distress/discomfort is
the minimum allowable without compromising scientific objectives
E.
Animals will have
food and/or
fluid restricted for an extended period of time.
Although such restriction may produce pain or distress, animals will not receive
anesthetics, analgesics, or tranquilizers since this will adversely affect the study.
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Animal Group
Control
Experimental
Teaching/training
Number of Groups
Animals per Group
II.
NUMBER AND TYPE OF ANIMALS REQUIRED:
A.
Indicate animal use by completing the following table.
Species
B.
Strain
Sex
Age
Size (gms)
(if appropriate)
Number to be
Used
Summary of total number and type of animals required per year. (Specify if multiple species
will be used.)
Number of Animals
to be Used/Year:
x Number
of Years
= Total
Vendor:
C.
Justify the number of animals to be used: include statistical significance, quantity of
tissue needed or other factors that may impact your study.
D.
Explain the rationale for using vertebrate animals in this project rather than an alternative
model such as tissue culture, non-vertebrate species or computer modeling.
III.
ANIMAL HUSBANDRY AND CARE:
A.
Animal Facility room(s) where animal work will be performed: (Check all that apply):
Operating room
Treatment or procedural room
Necropsy room
B.
Food preparation room
Quarantine facility
Services usually provided by the Animal Care Technician that you anticipate being
required for your project: (Check all that apply):
Special housing requirements (diet, lighting, isolation, etc.)
Technical assistance
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Filtered transport caging or vehicles
C.
Research/teaching laboratory room(s) OUTSIDE the Animal Facility in which animal
work will be performed: (Note: Except where special permission has been granted by the IACUC,
animals taken out of the facility may not be returned to the facility unless they are placed in quarantine.)
Room
Building
1.
Indicate the length of time the animals will be kept in this location.
2.
Describe the housing and care the animals will receive.
IV. SAFETY:
A.
Identification of Hazardous Agents. (Describe any of the following to which living animals will be
exposed during the experiment. Include concentration and dosage where applicable):
1.
2.
3.
4.
B.
Biologic agent:
Physical agent:
Radioactive agent:
Chemical agent:
Management of Hazardous Chemical, Physical, Radioactive and Biologic Agents:
1.
What procedures will be used to minimize exposure to research animals as well
as investigators and facility personnel during preparation and administration of
hazardous agent?
2.
Will special procedures be required for disposal of animal waste? (e.g. Is the
waste material a hazard to investigators/facility personnel?) If yes, please indicate
how decontamination of the waste material and/or carcasses will be
accomplished.
3.
Will special procedures be required for storage of toxic or hazardous materials? If
yes, please indicate the appropriate storage conditions.
4.
Please list all non-pharmaceuticals that will be injected. For each nonpharmaceutical listed, please check all that apply. For any items checked, please
justify the use of the non-pharmaceutical compound. To list additional non-
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pharmaceuticals, please attach another sheet to the application form with
compound name, one of the three reasons and justification.
a.
Non-Pharmaceutical name:
No equivalent veterinary or human drug is available. If yes, explain and
justify.
The non-pharmaceutical compound is required for replication. If yes,
explain and justify.
The pharmaceutical grade of the compound is not suitable for use for the
goal of the project. If yes, explain and justify (e.g. not concentrated
enough, cannot be used for the desired route of administration, has
inadequate formulation for administration to animals, etc.)
b.
Non-Pharmaceutical name:
No equivalent veterinary or human drug is available. If yes, explain and
justify.
The non-pharmaceutical compound is required for replication. If yes,
explain and justify.
The pharmaceutical grade of the compound is not suitable for use for the
goal of the project. If yes, explain and justify (e.g. not concentrated
enough, cannot be used for the desired route of administration, has
inadequate formulation for administration to animals, etc.)
V.
ANIMAL WELFARE:
List individuals(s) with authority to approve animal treatment or euthanasia.
1.
Principal Investigator:
Work phone:
2.
Principal Investigator designate:
Work phone:
(Cannot be the Animal Care Technician)
Signature of Principal Investigator designate:
NOTE: If the designated individuals(s) cannot be reached within a reasonable length of time, the IACUC
veterinarian will provide supportive care or euthanize moribund animals or animals suffering pain
according to his/her professional judgment.
VI. PERSONNEL QUALIFICATIONS AND TRAINING:
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A.
Indicate the qualifications of professional, technical, or student personnel actually
performing experimental procedure(s) by completing the following table.
Last Name,
Initials
B.
Degree,
Certification, or
Licensure
Date of Most
Recent TWU
Training
Date of Other
Training
Experience
With Species
(years)
Experience with
Procedure(s)
(years)
If an investigator, student, or technician listed in this protocol application is performing
the procedure for the first time, describe the type of training he/she will receive, the
person(s) who will provide that training, and the qualifications of that person to provide
such training.
VII. EXPERIMENTAL PROTOCOL:
A.
B.
Describe the experimental protocol relating to animal use.
1.
Provide a FLOW CHART showing the sequence of test and control procedures and
number of animals involved. Remember to include anesthetics, analgesics, and
tranquilizers; dosages; and routes of administration.
2.
Describe the provisions for post-operative care if survival surgery is part of the
experimental procedure. Include anesthetics, analgesics, tranquilizers and
antibiotics; dosages; and routes of administration.
3.
Describe euthanasia techniques. If drugs will be used, indicate dosages and routes
of administration. If other methods of animal disposition will be used, please
describe the method.
Provide justification if experimental procedures involve unusual stress such as prolonged
restraint of animals (greater than one hour), footshock, or deprivation. Describe the care
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the restrained animals will receive. A literature search should be included to ensure that
alternative methods are not available/appropriate. Include a description of the electronic
database(s) searched, the keywords used, the years searched, the date search was
conducted and the results of the search, in effect, did you find useful references.
C.
Provide thorough justification if the experimental procedures involve pain, discomfort, or
anxiety without the use of appropriate anesthetic, analgesic, or tranquilizing drugs.
Include a description of the electronic database(s) searched, the keywords used, the
years searched, the date search was conducted and the results of the search, in effect,
did you find useful references.
D.
Provide a thorough justification for the use of potentially hazardous agents. Include a
description of the electronic database(s) searched, the keywords used, the years
searched, the date search was conducted and the results of the search, in effect, did you
find useful references.
I certify that the statements herein are true, and that I will immediately notify the IACUC and/or
appropriate Safety/Radiation/Biohazard representative in writing of any significant changes in this
information.
As a principal investigator, I accept and will conform to all federal and institutional policies or guidelines
concerning the care and use of animals in research, teaching, or testing.
________________________________________
Signature of Principal Investigator/Instructor
_______________________
Date
(Your Protocol Application MUST be Signed and Dated. Thank You.)
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