PROTOCOL #
00-000
APPROVED:
ANIMAL CARE AND USE PROTOCOL
EXPIRES:
OFFICE USE ONLY
PRINCIPAL INVESTIGATOR AND GENERAL PROTOCOL INFORMATION
This submission is a (check [X] one):
[ ] New Study
[ ] Renewal: Previous protocol: [# ] Expires [DATE]
[ ] Amendment - Complete Amendment Record below
Project Title:
Project Type
(Check [X] one):
[ ] Breeding
[ ] Contract
[ ] Other, please describe _
[ ] Field
[ ] Research
[ ] Teaching
Funding Source(s): _
Grant Title(s): _
Principal Investigator:
Position (check [X] one): [ ] Tenure track/clinical professor [ ] Research Scientist [ ] Lecturer [ ] Emeritus [ ] IUB DVM
Only individuals of the above ranks may serve as a PI. All electronic protocol submissions must be generated by or copied to the PI.
Email: _
Department: _
Phone: _
Campus Address: _
Co-PI (if applicable): _
Position (check [X] one):
Email: _
Department: _
Phone: _
Campus Address: _
*Emergency after-hours phone: _
[ ] Tenure track/clinical professor [ ] Research Scientist
[ ] Lecturer
[ ] Postdoctoral Fellow [ ] Visiting Scientist
[ ] Research Associate
[ ] Technician
*Emergency after-hours phone: _
Does this study involve live animal use at another campus or institution?
If yes, please explain: _
OFFICE USE ONLY
Approved on:
Conditions or modifications:
BIACUC Chair or Authorized
Signature
[ ] yes [ ] no
[ ] Emeritus
[ ] Graduate Student
BLOOMINGTON INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (BIACUC)
# 00-000-00
PI Signature Page
The signature on this form demonstrates the responsibility of the Principal Investigator, and if
applicable the co-PI, for all activities and personnel related to this study or class.
 I assure the safe and ethical conduct of all research conducted with animals and that the
research complies with the IUB’s Letter of Assurance to OLAW and all applicable state and
federal laws governing animal welfare.
 I assure that discomfort and injury to animals will be limited to that which is unavoidable in the
conduct of valid scientific research or teaching and that this study does not unnecessarily
duplicate previous research or experiments.
 I will provide veterinary-approved anesthesia and analgesia for procedures that cause pain,
distress or discomfort to animals.
 All research personnel listed on the protocol must have completed the IACUC-required CITI
online training and have been medically cleared by the Occupational Health and Safety group
prior to participating in animal-related activities.
 I will directly inform all project personnel of the IACUC-approved procedures and methods prior
to their participation in animal-related activities. The approved protocol and all amendments will
be read by and will be readily available to project personnel.
 I certify that all experiments involving live animals will be performed under my supervision or
that of another qualified scientist.
 I will ensure that appropriate licenses and permits for collecting wild animals have been
obtained before conducting animal activities.
 I assure that the animal use section of any associated grant accurately reflects the animal use. I
understand that noncompliance with the laws, regulations, policies, and guidelines can result in
the suspension of approved activities for conducting animal research, teaching, and testing.
Noncompliance with the care and use of animals in research, teaching and testing can jeopardize
the IUB’s ability to procure external and internal research funding and may be reportable to the
USDA, OLAW and the NIH.
PI Signature:
Date:
Co-PI Signature:
Date:
BIACUC Protocol 2015
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PROTOCOL SUMMARY AND PROCEDURES/EXCEPTIONS
This application consists of two parts: The following REQUIRED sections (1-8), and the additional sections (A-I). Your answers to the
required sections will determine if additional sections are applicable and require completion.
REQUIRED SECTIONS
Amendment Record (for amendments only)
1.
Animal Requirements & Husbandry
2.
Rationale for Involving Animal Subjects
3.
Purpose of Proposed Research
4.
Description of Experimental Design and Animal Procedures
5.
Experimental Manipulations
6.
Assurance that Proposed Work Does Not Unnecessarily Duplicate Previous Research
7.
Teaching Proposals
P.
Project Personnel
ADDITIONAL SECTIONS
A. Surgery
B.
Anesthesia
C.
Minimization of Pain and Discomfort
D. Experimentally Induced Disease or Condition E.
Euthanasia
F.
Hazardous Substances
G. Breeding, Ordering, or Using Pregnant Animals
H. Standard Operating Procedure (SOP) for Investigator Maintained Animals
I.
Pain & Distress Rating Scale Template
J.
Field Study
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AMENDMENT RECORD
a. To submit an amendment to a previously approved protocol, incorporate the requested changes by using the Track
Changes option in this WORD document. If you prefer a different option, highlight changes with different color text or with
the highlight tool, ensuring that deleted text is changed to strikethrough.
b.
Provide a brief summary of the proposed revision(s) in the section below:
Date
Summary
1.
_
_
2.
_
_
3.
_
_
4.
_
_
5.
_
_
6.
_
_
7.
_
_
8.
_
_
9.
_
_
10.
_
_
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BIACUC Protocol 2015
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1.
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Animal Requirements & Husbandry
Note: If ordering or using pregnant females, indicate the number of pregnant females separate from the number of offspring
that will be used as subjects. If breeding animals as part of this protocol or ordering pregnant animals for use or to produce
litters, complete Section G: Breeding, Ordering, or Using Pregnant Animals
1.A.
Species
Scientific name
1.A.1.
Common name
Total number of
animals
Housing area(s)
Are any of the Genetically Modified Animals (GMA) a newly generated line for this study?
Use areas (include room
numbers)
[ ] Yes [ ] No
If yes, also complete Section D: Experimentally Induced Disease or Condition.
NOTE: Use of genetically modified animals requires IBC approval. See:
http://researchadmin.iu.edu/Biosafety/IUB/bio_home.html#biosafety
1.A.1.a. If genetically modified animals are to be used, describe any phenotypic consequences of the genetic manipulations to the
animals and any special care or monitoring that the animals will require. If this is a newly generated line of GMA or if
phenotypic consequences are unknown, also complete Section D: Experimentally Induced Disease or Condition.
1.A.2.
Renewal Transfer: If this is a three-year renewal, approximately what number of animals will be transferred from the
previous protocol?
Species currently in use
1.B.
Strain
Number of Animals
Source of Animals
Where will animals be obtained for this study? Check [x] all that apply.
1.B.1.
[ ] An LAR-approved vendor
You are free to purchase animals from ANY of the resources on the approved vendor list. The currently approved vendors
may be downloaded from the BIACUC Forms web site: http://researchadmin.iu.edu/IACUC/IUB/biacuc_forms.html.
LAR does not pre-approve suppliers for frogs or fish. If requesting one of these species, please list the vendor below:
_
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1.B.2.
[ ] Bred in-house specifically for this protocol. Complete Section G: Breeding, Ordering, or Using Pregnant Animals –(unless
animals are bred under another protocol)
1.B.3.
[ ] Transferred from another IU protocol: #
List all activities and procedures that animals from the above protocol(s) will undergo prior to transferring them.
_
1.B.4.
Is the proposed animal a wildlife species? (The population status of a wildlife species is to be considered prior to procurement.)
[ ] No
[ ] Yes - Complete Section J: Field Study
1.B.5.
[ ] Other, please specify: _
1.C.
Transportation
1.C.1.
If animals are not obtained from a commercial vendor, how will animals be transported to IU?
_
1.C.2
If animals are to be transported between buildings within the IU campus, describe the transportation method.
NOTE: Whenever possible a University-owned vehicle should be used to transport animals. The use of personal vehicles for
animal transport is discouraged due to concerns with potential animal biosecurity, safety, health and liability risks for the
animals, personnel and Institution. If it is necessary to use a personal vehicle, the following conditions must be met and
described below:
1. Provide the justification for using a private vehicle.
2. The animal enclosures must be appropriately secured to prevent falling.
3. Traditional laboratory animals (rodents, rabbits, etc.) should be protected from direct sunlight.
4. Closed vehicles used for animal transport must be environmentally controlled (e.g., heating, ventilation, air
conditioning).
5. Plastic or a similarly impermeable material that can be sanitized should be placed under the transport cages/carriers.
_
1.D.
Husbandry, LAR-core Facility
Per the 8th edition of the Guide: Social animals should be housed in stable pairs or groups of compatible individuals unless
they must be housed alone for experimental reasons or because of social incompatibility.
1.D.1.
Will social animals be single-housed for more than 24 hours?
[ ] Yes
[ ] No
[ ] NA
If social animals are to be single-housed for more than 24 hours, provide justification, including reasons related to (1)
husbandry, (2) experimental necessity, and/or (3) health, as appropriate. Include the maximum amount of time that
animal will be single-housed.
_
1.D.2.
Will individually-housed animals receive environmental enrichment?
[ ] Yes
[ ] No
[ ] NA
If not, provide justification as described in the BIACUC Policy for Social Housing and Environmental Enrichment.
_
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1.D.3.
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If LAR staff will not have primary responsibility for daily care, please explain why and complete Section H: SOP for
Investigator Maintained Animals:
_
1.D.4.
Will animals be kept for 12 hours or more in any area other than a LAR-core housing facility?
[ ] Yes [ ] No
If yes, please list the location (building, room number), number of animals, and provide justification.
_
2.
Rationale for Using Animal Subjects
2.A.
Explain your rationale for animal use:
_
2.B.
Describe the characteristics that make this species appropriate for this study or class.
_
2.C.
Justify the number of animals to be used. Describe how the number of animals needed was determined by detailing the
various experimental groups that will be used and any related statistical calculations. Insert supportive tables or graphics
here. [The number of animals should be the minimum number required to obtain statistically valid results.]:
_
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3.
Purpose of Proposed Research
Please provide a brief description of your research project in non-scientific, lay person terminology, outlining the purpose of
your research and justifying the use of research animals. Include at least one sentence, explaining why the study is
important to human or animal health, the advancement of knowledge, or the good of society.
_
Will this research involve a Pilot Project?
[ ] No
[ ] Yes (If yes, please describe in Section 4.)
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Description of Experimental Design and Animal Procedures
Include a complete description and timeline of the proposed use of animals. Describe methods and procedures that involve
the use of live animals and the purpose of each experiment or set of related experiments. Begin with the hypothesis being
tested and/or the rationale for each experiment to be performed. Provide a clear understanding of what happens
sequentially to each animal or group of animals, and the time period over which the procedures will occur. Include
experimental tables, diagrams and/or pictures to add clarity.
NOTE: Details of surgical procedures should be provided in Section A: Surgery
_
4.A.
Use of non-pharmaceutical grade drugs, substances or compounds
Will all chemicals and substances used in animals be of pharmaceutical grade? [ ] Yes
4.A.1.
[ ] No
If no, list those that are not available in pharmaceutical grade:
_
4.A.2.
If no, describe methods used to ensure the sterility of the non-pharmaceutical grade compounds. Refer to the BIACUC Use
of Non-pharmaceutical Grade Compounds in Animals policy for guidance.
_
4.A.3
If no, and pharmaceutical grade is available, list each substance and provide scientific justification for their use. Include
details such as grade, purity, sterility, acid-base balance, pyrogenicity, osmolality, stability, side effects, adverse reactions,
storage, pharmacokinetics, and vehicles, which are taken into consideration because of the potential for causing pain or
distress to the animal.
_
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5.
Experimental Manipulations
5.A.
Is surgery to be performed?
[ ] Yes [ ] No
If yes, complete Section A: Surgery, Section C: Minimization of Pain and Discomfort, and, if the surgery is survivable, provide
an appropriate Pain & Distress Rating Scale (See Section I)
5.B.
Are anesthetics to be administered? (Does not apply if anesthesia is used only for euthanasia. Go to Section E.)
[ ] Yes If yes, complete Section B: Anesthesia
5.C.
[ ] No
[ ] N/A
Will animals have or experience any of the following: [ ] Yes [ ] No
BIACUC Protocol 2015

A serious or experimentally-induced disease or condition, which may also include genetically modified
animals of phenotypic consequences that interfere with the animals’ health and comfort;

More than momentary pain and discomfort (procedures expected to cause pain or distress in a human
should also be considered painful to animals);

Food or water withheld;
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
Prolonged restraint, where an animal is confined or immobilized for extended periods of time;

Aversive stimuli
If yes, complete the following sections:
Section C: Literature Search - Minimization of Pain and Discomfort;
Section D: Experimentally Induced Disease or Condition;
5.D.
Do the activities described in this protocol require the use of hazardous materials, including biological materials, chemicals,
and/or radioactive substances?
[ ] Yes [ ] No If yes, complete Section F: Hazardous Substances
6.
Animal Disposition How will animals be disposed? Check [x]all that apply.
[
[
[
[
[
] Adoption (See policy on Disposition of Animals)
] Euthanasia (complete Section E: Euthanasia below)
] Return to colony
] Return to the wild
] Transfer to different project. Protocol(s) #
[ ] Death is to be an endpoint. Provide scientific justification: _
[ ] Other (Please explain): _
NOTE: The Institutional Biosafety Committee (IBC) policy prohibits the donation of animal carcasses to outside entities. For
more information on this policy see: http://www.researchadmin.iu.edu/Biosafety/IUB/bio_home.html
7.
Assurance That Proposed Work Does Not Unnecessarily Duplicate Previous Research
Does the animal use described in this protocol unnecessarily duplicate previous research or teaching?
[ ] Yes [ ] No
If yes, please explain: _
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ADDITIONAL SECTIONS – Check [X] each additional section(s) you are completing with this protocol application.
[ ] Section A: Surgery – Complete for either survival or non-survival surgeries.
[ ] Section B: Anesthesia – Complete if using anesthesia or analgesia for either survival or non-survival surgeries.
[ ] Section C: Literature Search - Minimization of Pain and Discomfort – Protocols using USDA-covered species that will
experience a painful procedure or technique, or causes a USDA-covered animal to experience distress must include a
literature search to demonstrate adherence to the three Rs and minimization of pain and distress.
[ ] Section D: Experimentally Induced Disease or Condition – Including, but not limited to, any procedure that includes more
than momentary pain and discomfort, withholding food and/or fluids, prolonged restraint, aversive stimuli or genetically
modified animals with either adverse or unknown phenotypic consequences.
[ ] Section E: Euthanasia
[ ] Section F: Hazardous Substances – Complete if the proposed study uses any hazardous substances. biological agents,
chemical, radioactive, or other hazardous substances.
[ ] Section G: Breeding, Ordering, or Using Pregnant Animals – Complete if ordering pregnant females OR if breeding animals
under this protocol.
[ ] Section H: Standard Operating Procedure (SOP) for Investigator Maintained Animals – Complete if animal husbandry will
not be provided LAR staff.
[ ] Section I: Pain & Distress Rating Scale Template – If you checked Sections A (survival surgeries only), C, or D, complete this
section. Revise as appropriate for your species and/or procedures.
[ ] Section J: Field Study – Complete if conducting a field study and/or working with wildlife.
[X] Section P: Project Personnel – Complete for ALL persons, including the Principal Investigator, working with animals under
this study.
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Section A :: Surgery
In compliance with federal regulations (the Animal Welfare Act and Public Health Service Policy), all survival surgery in vertebrate
animals must be performed using aseptic procedures, including surgical gloves, masks, sterile instruments and aseptic techniques.
Non-rodent mammalian survival surgery must be performed in an operating room used only for surgery. See the BIACUC surgery
policies
The proposed surgery will be (check [X] Acute/non-survival and/or Survival, as appropriate):
A.1.
[ ] Acute/non-survival: The animal will remain anesthetized during the entire procedure and will be euthanized without
awakening. Provide the following information and complete Section B: Anesthesia and Section E: Euthanasia
A.1.a)
Location (building and room number) where surgery will be performed: _
A.1.b)
Describe animal pre-operative preparation, surgical site preparation, and description of procedures to be performed:
_
A.1.c)
Describe the experimental endpoint:
_
A.2.
[ ] Survival: The animal will awaken from anesthesia. Major survival surgery is defined by the Guide for the Care and Use
of Laboratory Animals as penetrating and exposing a body cavity or producing substantial impairment of physical or
physiological function. Complete Section B: Anesthesia, Section C: Minimization of Pain and Discomfort and Section I: Pain
& Distress Rating Scale
A.2.a)
Location (Building and Room number) where surgery will be performed: _
A.2.b)
Describe the surgical procedures. Include pre-operative care of the anima and aseptic preparation of the animal, surgeon,
instruments and surgical site. Describe the anatomical location and approximated size of the incision site(s), placement site
and size of catheters or implantable devices and all suture material:
_
A.2.c)
Who will be responsible for providing post-operative care?
_
A.2.d)
Description of post-operative care, including supplemental heat, administration of fluids or analgesics, frequency of animal
observations, and all drugs to be administered following surgery. Specify frequency of observation and drug administration
in terms of timed intervals (e.g. every 6 hours, NOT 4 times a day).
_
A.2.e)
Describe the clinical signs that are normally expected in the animals as a result of the procedure(s) (e.g., tumors, surgical
wounds, weight loss, behavioral abnormalities, illness, etc.).
_
A.2.f)
What post-operative complications are reasonably possible and how will they be addressed?
_
A.2.g)
If multiple major survival surgical procedures (MMSS) will be performed on any animal, justify why this must occur.
_
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Section B :: Anesthesia and Analgesia
Complete this section if anesthesia or analgesia is to be administered. Procedures that cause more than momentary or slight pain or
distress to the animal must be performed with appropriate analgesia or anesthesia. The regime should be developed in consultation
with an IU veterinarian. Procedures to be conducted without appropriate anesthesia must be scientifically justified.
B.1.
Pre-operative regimen: State the length of withholding food and/or water and list pre-anesthetic drugs administered,
including dosage and routes of administration.
_
B.2.
Anesthetic regimen: Provide a listing of all induction, maintenance, and muscle relaxant drugs, including dosages and
routes of administration.
_
B.3.
Analgesic drugs: Provide the drug name(s), dosage(s), routes and frequency of administration. If analgesic drugs cannot be
administered, provide scientific justification for withholding them.
_
B.4.
Procedures and methods: Describe procedures that will be used to indicate that an appropriate plane of anesthesia is
being maintained. Include the frequency of monitoring the animal, the criteria that will be used to determine if
administration of additional anesthetic agent is required, and how records of the anesthetic procedures are kept.
_
B.5.
Gases: If volatile gases (e.g., isoflurane) are to be used, describe the scavenging technique.
_
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Note: IACUC-Approved Drug Formularies
LAR provides formularies (veterinary-approved lists of drug recipes, routes of administration, etc.) for mice, rats,
hamsters, rabbits, and birds. These formularies can be found here:
http://lar.indiana.edu/drug-formularies/
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Section C :: Literature Search - Minimization of Pain and Distress in USDA-covered Animals
Every protocol that involves USDA-covered animals experiencing more than momentary pain or distress must include a literature
search to ensure minimization of pain and distress in animals and demonstrate adherence to the Three Rs.
The Animal Welfare Regulations (AWA) require investigators to consider alternatives to procedures that may cause more than
momentary or slight pain or distress to the animals, providing a written narrative of the methods used and sources consulted to
determine the availability of alternatives. For more information see USDA Policy #12
In 1959, researchers William Russell and Rex Burch published The Principles of Humane Experimental Techniques with the objective
of establishing the “…humanist possible treatment of experimental animals.” The authors proposed the principles of the 3R’s:
Replacement, Reduction and Refinement. Application of the 3R’s includes:
 Replacement – Methods to substitute nonliving materials or in vivo processes to achieve scientific goals.
 Reduction – Methods to minimize the number of animals used for a study or class.
 Refinement – Methods to reduce animal pain, discomfort and distress within the study or class.
Perform a literature search to determine if alternatives, especially those supporting refinement, exist.
Please cite specific sources in the table below. You must consult at least two databases. IU Libraries provide access to
multiple databases via One Search: http://www.libraries.iub.edu/index.php?pageId=1697&mode=subjectId
In the search strategy, include keywords that are relevant to the procedure(s) and proposed uncomfortable or painful
methods. The search may also include drugs and/or compounds administered to the animals as well as alternate
experimental designs, housing/restraints modifications, etc.
C.1.
REPLACEMENT: If non-vertebrate species, in vitro systems or computer simulation cannot be used, please explain why.
_
C.2.
REDUCTION: Please explain how the number of animals requested fulfills the objective of reduction.
_
C.3.
REFINEMENT: Please explain methods used to minimize pain, discomfort and/or distress that animals might experience.
_
C.4.
List keywords, which should be specific to the study or class.
_
C.4.a.
Date of Search: _
C.4.b.
Years Covered by Search: _
C.4.c.
Databases Consulted (Two, minimum): _
C.5.
Describe the potential alternatives discovered in your search. If you are rejecting any of the alternatives, provide scientific
justification for doing so.
_
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Section D :: Experimentally Induced Disease or Condition
A Pain & Distress Rating Scale (See Section I) must be completed for this protocol if the animals have a serious natural or
experimentally induced condition.
D.1. Describe the animal’s condition/disease and expected clinical signs. Include how the progression will be monitored and the
frequency of observations. Include clinical conditions such as tumors, surgical wounds, weight loss, behavioral abnormalities,
illness, etc.
D.2.
Endpoint Criteria: What are the specific objective criteria or endpoints for toxicity or euthanasia? Describe the criteria and
the intervention used to prevent unnecessary pain and distress. Criteria may include, but are not limited to:
 Weight loss beyond a predetermined limit
 Pain or distress not controlled by with analgesics
 Loss of normal movement
 Loss of normal feeding or drinking behavior
Intervention may include, but is not limited to:
 Euthanasia
 Discontinuation of a procedure
 Removal from the study
_
D.3.
What measures will be taken to alleviate or minimize pain/distress? (e.g., analgesics, other manipulations)
_
D.4.
If any methods/techniques listed below will be used, check the appropriate box and provide the requested details.
D.4.a)
[ ] Administration of a hazardous/toxic substance: List the substance name, site of administration, volume, and frequency.
_
D.4.b)
[ ] Prolonged restraint: Prolonged restraint is keeping an animal confined or immobilized for time periods in excess of
those required for administration of treatments or routine handling procedures. Describe the restraint method, duration,
frequency, and acclimatization period for the animal to the restraint device.
_
D.4.c)
[ ] Food/water deprivation: Describe the duration, frequency, extent (total/partial), and methods that will be used to
monitor and assess.
_
D.4.d)
[ ] Abnormal environment: temperature, humidity, light, duration, bedding changes.
_
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D.4.e)) [ ] Aversive stimuli: type and intensity of stimulus, duration, and justification for use.
_
D.4.f)
[ ] Tumor Development
_
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Section E :: Euthanasia
Consistent with AVMA Guidelines on Euthanasia, the BIACUC requires that following euthanasia by CO2, death be confirmed through
secondary method such as bilateral pneumothorax, decapitation, or cervical dislocation. Any exception to this requirement must be
scientifically justified and approved by the BIACUC.
E.1.
Chemical Method – check[X] all that apply
[ ] Lethal injection using a commercial or laboratory prepared euthanasia solution at the recommended dosage. Specify
the name, dose, and route of administration.
_
[ ] Inhalation of anesthetic gases. Please specify agent: _
For inhalation of anesthetic gases, what scavenging technique will be used?
[ ] Charcoal filter
[ ] Fume hood
[ ] Snorkel system
[ ] Other. Please specify: _
[ ] Inhalation of carbon dioxide (rodents, amphibians, birds). Check physical method of assurance below.
[ ] Inhalation of carbon dioxide administered by LAR staff according to the LAR SOP.
E.1.a)
If euthanasia is to be induced by a chemical method without a secondary method, describe how death will be assured.
E.2.
Physical Method - check[X] all that apply
[ ] Cervical dislocation
[ ] Decapitation
[ ] Bilateral pneumothorax
[ ] Perfusion/exsanguinations
[ ] Other:
E.2.a)
If the euthanasia is to be induced by a physical method without the use of anesthetics or sedatives, provide scientific
justification:
_
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SECTION F :: HAZARDOUS SUBSTANCES
Complete this section only if the project requires the use of any of the following agents in live animals, or if any of the agents may
pre-exist in the species you are using. Check all agents that apply and identify the agent. Include dose, route, and frequency for
treatment, post-mortem handling of animals or tissue, and any other exposure scenario for personnel.
F.1.
Use of the following agents requires review by the Institutional Biosafety Committee (IBC) and/or the Biosafety Office
(biosafe@indiana.edu). Also see: http://researchadmin.iu.edu/Biosafety/IUB/bio_home.html.
If you currently have secured IBC protocol approval for your animal research study, please include the IBC protocol
number here:
Check [X] and identify if using any:
[
[
[
[
] Biological toxin: _
] Infectious agent: _
] Recombinant DNA: _
] Transplantable cell line: _
F.1.a)
Level of review – check [X] all that apply
[ ] BL1
[ ] BL2
[ ] BL3
[ ] Not yet determined
F.2.
Use of the following requires Radiation Safety Training. Contact the Radiation Safety Officer at 855-3230.
[ ] Radioisotopes: _
F.3.
Use of the following agents requires Chemical Safety Training. Contact EH&S 855-6311 for assistance or see
http://www.ehs.indiana.edu/lab_safety.shtml. - Check [X] and identify all that apply.
[ ] Carcinogens: _
[ ] Controlled substances, prescription drugs, or intoxicants: _
[ ] Novel substances: _
[ ] Reproductive hazards: _
[ ] Toxic chemicals: _
F.4.
What precautions will be taken to protect personnel involved in the protocol? Describe all personal protective equipment.
_
F.5.
Describe any special waste and/or carcass disposal requirements (carcinogen, biohazard, radiation, etc.).
_
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SECTION G :: BREEDING
If more than one species/strain is to be bred for this study, complete a separate Section G for each species/strain. If the animals
for this study are bred under another protocol, then do not complete this section.
G.1.
Species _
Strain _
G.1.a)
For genetically altered animals, include the gene altered: _
G.1.b)
Are all housing and handling practices standard?
[ ] Yes [ ] No
If no, describe all deviations from standard procedures and practices. _
G.2.
Purpose
G.2.a)
Will animals be bred specifically for this study?
G.2.b)
If yes, describe the reasons below. Could these animals be purchased from a commercial vendor? Complete Sections G.3
and G.4 below. _
G.2.c)
Will you be purchasing pregnant animals?
[ ] Yes [ ] No
If yes, will offspring be produced?
[ ] Yes [ ] No
[ ] Yes [ ] No
If yes, complete section G.4. below.
G.3
Breeding
G.3.a)
Source of breeding stock _
G.3.b)
Number of breeding animals that will be held, but not subject to experimental manipulations:
# males: _
# females: _
Total number: _
G.3.c)
Mating scheme
Continuous - If continuous, how many months or years will the females be bred? _
Interrupted - If interrupted, how frequently will the females be bred: _
Maximum number of litters/births before retiring females: _
Disposition of retired breeders (males and females). _
If euthanasia, please state method: _
G.3.d)
Briefly describe colony management. Include methods of tracking the number of births and disposition:
_
G.4.
Offspring Produced and Disposition
G.4.a)
For rodents, at what age, or range of ages, will weaning occur? _
G.4.b)
Estimate the number of animals produced that will be subject to experimental manipulations: _
G.4.c)
Estimate the number of offspring produced by this colony that will be euthanized, and will not be subject to experimental
manipulations: _
G.4.d)
Explain the how this number (G.4.c)) was determined and justify. Include culling for sex selection or to achieve
standardized litter size: _
G.4.e)
Approximate total number of offspring produced (sum of G.4.b) and G.4.c), above): _
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SECTION H :: STANDARD OPERATING PROCEDURES FOR INVESTIGATOR-MAINTAINED ANIMALS
** Animals must be observed daily (365 days a year), including weekends and holidays **
H.1.
Person(s) Responsible for Providing Animal Care: _
H.2.
Room Number(s)/Building Name: _
H.3.
Other Activities Conducted in This Room: _
H.4.
Species (List All or Provide Separate SOP for Each): _
H.5.
What type of tank, tub, or cage ("primary enclosure") is used for housing?
H.5.a)
Materials and construction: _
H.5.b)
Size of enclosure and maximum number of animals per enclosure: _
H.5.c)
How are feed and water provided within each (bowls, on floor, special devices, etc.)? _
H.6.
What methods if any are used to provide or monitor essential levels of the following environmental parameters? _
H.6.a)
Temperature? _
H.6.b)
Humidity? _
H.6.c)
Ventilation? _
H.6.d)
Illumination? _
H.6.d)
Noise? _
H.6.f)
Tank water quality? _
H.7.
Behavioral Management
H.7.a)
Structural environment: What structural features (e.g., for resting, climbing, perching, hiding) if any are added to
enclosures? _
H.7.b)
Social housing: Are animals housed singly or in groups; how are social groups maintained? _
H.7.c)
Activity: Are animals provided any means of activity outside of enclosure? _
H.8.
Food
H.8.a)
Type and Source (Vendor and Manufacturer if different) _
H.8.b)
Storage: Room number, refrigerated or frozen storage, type of feed container _
Note: Feed must be stored in a covered or sealed container separate from carcasses, tissues or chemicals used for research or
cleaning. Containers should be labeled with contents, milling/manufacture date or expiration date if applicable.
H.8.c)
Food Preparation: How and where (room # if different from housing area) is food prepared if applicable? _
H.8.d)
If live feed is provided, how is it maintained or fortified with additional nutrients? _
H.8.e)
How Is Food Provided (Frequency, quantity per animal or ad libitum)? _
H.8.f)
Quality Control: How long are feed or supplements maintained? _
H.8.g)
What other methods are used to insure adequacy of nutrients? _
H.9.
Drinking Water - Source, Treatment and How Provided (Tank water for aquatic species should be described in Section
H.5.)
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H.9.a)
Municipal (tap), well, other? _
H.9.b)
Filtered, chemically treated, autoclaved, testing performed, other? _
H.9.c)
Bottles, bowls, automatic watering system, other? _
H.9.d)
Frequency for replacing drinking water: _
H.10.
What type of bedding or substrate, if any, is used?
# 00-000-00
_
H.10.a) How often is it replaced? _
H.10.b) Where is it? _
H.11.
Sanitation
H.11.a) How often is tank water changed and approximately what percentage of water is changed each time? _
H.11.b) Where is soiled bedding or substrate removed? _
H.11.c) How often is the primary enclosure (tank, tub, cage or, if animals are loose in room, entire room) cleaned (as described in
section d. below)? _
H.11.d) Primary Enclosure Sanitation
H.11.d)(i)
Where are enclosures and caging accessories washed? _
H.11.d)(ii)
Hand washing, mechanical/machine washing, or autoclave usage? _
H.11.d)(iii)
Duration of exposure to sanitizing/disinfecting agent? _
H.11.d)(iv)
Is hot water or steam employed for sanitation? If so, provide temperature if measured: _
H.11.d)(v)
Other procedures designed to assure removal of gross soils, disinfection of surfaces, and adequate removal of
sanitizing chemicals? _
H.11.d)(vi) Cleaning/Sanitizing Agents Used: _
H.11.e) Cleaning and Disinfection of Secondary Enclosures (Room or Area Where Tanks or Cages are Held)
H.11.e)(i)
Animal Room Cleaning Frequency _
H.11.e)(ii)
Procedures or Methods (Equipment Used) _
H.11.e)(iii)
Sanitizing Agents _
H.11.e)(iv)
Support Area Cleaning _
H.11.e)(v)
Sanitation of Caging Accessories _
H.11.e)(vi)
Procedures and Frequency for Cleaning Feeders and Watering Devices _
H.11.e)(vii) Procedures and Frequency for Enrichment Devices or Other Structural Additions to Enclosures _
H.11.e)(viii) Soiled Bedding and Refuse: How is this handled and discarded? _
H.12.
Waste disposal
H.12.a) How are animal carcasses stored or discarded? (i.e. Frozen in sealed bags and request EH&S pick-up at
www.ehs.indiana.edu “Request Assistance” or other method) _
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H.12.b) Hazardous (and Non-Hazardous) Chemical, Radioactive, and Biological Agents, Waste, and Sharps Disposal (Call EH&S for
guidance 855-6311) including Packaging, Labeling, Disinfection (i.e. autoclave, chemical disinfection, etc.), Storage, and
Separation from Animals or Feed, Disposal: _
H.13.
Pest Control – describe vermin control program
_
H.14.
How Is Emergency, Weekend, and Holiday Care Provided?
_
H.15.
Identification and Records
_
H.15.a) Methods for Identification of Each Species _
H.15.b) What individual or group records do you maintain for identifying animals and their sources or pedigrees? _
H.16.
Breeding Colony Maintenance
H.16.a) What, if any, species, stocks or strains do you produce in-house? _
H.16.b) Describe the breeding scheme used to assure homozygosity of inbred lines or heterozygosity of outbred lines if applicable.
_
H.16.c) Do you do any genetic monitoring? If so, what do you test for and how? _
H.17.
Security
H.17.a) Who has access to room(s) where animals are maintained? _
H.17.b) How is area secured? _
H.17.c) How do you assure that only authorized people have access to animals under your care? _
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Pain & Distress Rating Scale and Long-Term Post Surgery Monitoring for Non-USDA Regulated Rodent
Animal is to be assessed with the determined pain score documented, at least every morning for a period no less than 14 days post procedure unless the animal has a total
score of 0 for 5 consecutive days.
Assessment Category
Assessment Score = 0
Assessment Score = 1
Assessment Score = 2
Assessment Score = 3
Attitude and Movement
Alert, freely moves about cage
Less active, moves around cage
only when stimulated
Will not move around cage when
stimulated
Lying on side
Coat and Posture
Smooth coat, not hunched
Hunched or ruffled fur
Hunched with ruffled fur
Surgical Site
Clean and not swollen
Appetite
Eating and drinking normally
Respiratory Rate
Breathing normally
Moderate* swelling and/or redness
Surgical site open exposing underlying
and pus and/or persistent scratching
subcutaneous tissues or intraat surgical site and/or pressing
abdominal cavity
surgical site to side or bottom of cage
Weight decreased by ≤10% compared
Weight decreased >10%, <20%,
Weight decreased by ≥20% compared
to pre-surgical weight
compared to pre-surgical weight
to pre-surgical weight
Clear discharge or redness or
mild* swelling or occasional
scratching at surgical site
Increased respiratory rate
Labored or difficulty breathing
Respiratory distress or open mouth
breathing
___________
Treatment Plan (in consultation with Attending Veterinarian)
 Scores = 3 in any category: euthanize immediately
 Scores = 2 in any category: consult with vet
 Score = 2 for Surgical Site: Administer analgesic & consult with vet
 Score > 1 in Appetite: Provide easy access to food- moist crushed feed in petri dish
 Animals will be weighed daily for 14 days; the Attending Veterinarian will be consulted if any weight loss exceeds 10% of the pre-surgical weight
*Mild swelling: Skin around incision raised but no increased tension on sutures;
Moderate swelling: Skin around incision raised causing skin tension around sutures or separation of incision
Protocol #:
TIME & DATE
Animal or Animal Group ID:
POSTURE
MOVEMENT
SURGICAL SITE
APPETITE
ELIMINATION
TOTAL SCORE
INITIALS
ACTION
1.
2.
3.
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Protocol #:
TIME & DATE
# 00-000-00
Animal or Animal Group ID:
POSTURE
MOVEMENT
SURGICAL SITE
APPETITE
ELIMINATION
TOTAL SCORE
INITIALS
ACTION
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Date surgery site healed: __________
Incision is closed, no redness associated with wound, and no scabbing is present
________________________________________________________
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SECTION J :: FIELD STUDY DESCRIPTION
J.1.
Is the species endangered? [U.S. Fish & Wildlife Service Endangered Species Database]
[ ] Yes
J. 2.
[ ] No
Will animal care and/or use take place in the wild or at a field site?
[ ] Yes
[ ] No
If yes, describe the location(s) where the field study will be performed and/or where captive animals will be housed and
used.
_
[The BIACUC recognizes that it is not always possible to predict at the initiation of field studies all potential observation or
collection opportunities. PIs must inform the IACUC of new location opportunities as they develop by submitting an
amendment.]
J. 2.a.
If the study will take place on private land, has the landowner’s permission been obtained?
[ ] Yes [ ] No
J.3.
Do you agree to obtain all the required, applicable permits before starting the study?
[ ] Yes [ ] No
J.4.
Will animals be captured alive?
[ ] Yes [ ] No
J.5.
Describe the method of capture and frequency of trap checks, if applicable.
J.6.
If released, where will captured animals be released?
J.7.
If not released, what will happen to the animals?
J.8.
What precautions are taken to prevent capture of non-target species?
J.9.
What is the expected injury or death rate during capture?
J.10.
In the event of illness or injury to the animal during capture, how will this be addressed?
J.11.
Will a telemetry unit be implanted?
[ ] Yes (Complete J.12)
[ ] No
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J.12.
# 00-000-00
For Field Studies implanting or attaching a telemetry unit:
Identify who will perform the implant/attachment and list their qualifications:
_
Describe the dimensions and weight of the unit; the anatomical site; procedure for removal or likely consequence to the animal if not
removed:
_
J.13.
Will animals be held in captivity for: More than 12 hours (AWA)?
More than 24 hours (PHS)?
J.14.
[ ] Yes [ ] No
[ ] Yes [ ] No
If the answer is YES to either question above, please describe:






The planned duration of captivity
The holding facility that you intend to use, including cage size/dimensions
Equipment to be used
Food/fluid strategies
The maintenance for a suitable environmental condition
Release procedures, if applicable
Note: A diagram or photograph of equipment and/or the housing/cages may help to clarify the description.
J.15.
If applicable, describe how the animal(s) will be transported and under what conditions.
J.16.
Non-Target Species: Include any non-study animals affected by this research, including those that may be captured and/or
killed or disturbed. If unable to provide a specific list, then you may include a general descriptor such as “all native
mammals to the specified area.” The total number may be reported when the procedure has been completed.
Non-target Species
J.17.
Strain
Number of Animals
If IUB veterinary staff will not have primary responsibility for oversight, please describe the arrangement for
veterinary medical care. Note that the Attending Veterinarian must be informed of all animal health and welfare concerns.
If no veterinary care will be needed, please explain the circumstances. For example, a field study consisting of only direct,
unobtrusive observation of free-ranging animals in their natural ecosystem.
_
Please be sure to fill in Section 6, Final Disposition, and indicate if animals will be released or what the final outcome
will be for captive animals.
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P: PERSONNEL SECTION:
INSTRUCTIONS: List ALL personnel working with animals on this study (co-investigators, postdoctoral fellows, students, research
assistants, and technicians). The following information is required for each individual:
PI : _
Responsibilities Check [X] all that apply.
[
[
[
[
]
]
]
]
Anesthesia
[ ] Injections
[ ] Surgery – survival
Animal Handling
[ ] Perfusion
[ ] Surgery – non-survival
Euthanasia
[ ] Peri- or post-operative monitoring
Additional Responsibilities _
Experience: List individual’s previous training and experience using animals, including species information, identifying procedures
and experience level (e.g., how many years). Include where and by whom training was provided.
_
Training: Indicate who will provide current training and for which procedures. Include the qualifications of the trainer. How will skill
level and/or proficiency be determined? What are the qualifications for an individual to work independently?
_
BIACUC-CITI courses: http://researchadmin.iu.edu/EO/eo_citi.html. Check [X] all that apply.
[ ] Investigators, Staff and Students, Basic Course (All personnel to complete.)
[ ] Occupational Health and Safety Training for Personnel Working with Animals (All personnel to complete.)
Check species as appropriate:
[ ] Working with Rats
[ ] Working with Dogs
[ ] Working with Hamsters
[ ] Working with Mice
[ ] Working with Rabbits
[ ] Working with Amphibians
Training by Laboratory Animal Resources Personnel:
[ ] Aseptic surgery (Required prior to participating in any surgical procedures.)
Medical Clearance to Work with animals: http://www.iuhealth.net/web/eforms/cmifpwrams
[ ] Medical Surveillance Questionnaire and follow-up (All personnel to complete.)
Chemical Safety Training: see http://www.ehs.indiana.edu/lab_safety_training.shtml
[ ] Laboratory Safety and Chemical Hygiene Training
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# 00-000-00
Name : _
Network ID: _
Position : _
Dept/Program: _
Responsibilities Check [X] all that apply.
[ ] Anesthesia
[ ] Injections
[ ] Surgery – survival
[ ] Animal Handling
[ ] Perfusion
[ ] Surgery – non-survival
[ ] Euthanasia
[ ] Peri- or post-operative monitoring
[ ] Additional Responsibilities _
Experience: List individual’s previous training and experience using animals, including species information, identifying procedures
and experience level (e.g., how many years). Include where and by whom training was provided.
_
Training: Indicate who will provide current training and for which procedures. Include the qualifications of the trainer. How will skill
level and/or proficiency be determined? What are the qualifications for an individual to work independently? _
BIACUC-CITI courses: http://researchadmin.iu.edu/EO/eo_citi.html. Check [X] all that apply.
[ ] Investigators, Staff and Students, Basic Course (All personnel to complete.)
[ ] Occupational Health and Safety Training for Personnel Working with Animals ( All personnel to complete.)
Check species as appropriate:
[ ] Working with Rats
[ ] Working with Dogs
[ ] Working with Hamsters
[ ] Working with Mice
[ ] Working with Rabbits
[ ] Working with Amphibians
Training by Laboratory Animal Resources Personnel:
[ ] Aseptic surgery (Required prior to participating in any surgical procedures.)
Medical Clearance to Work with animals: http://www.iuhealth.net/web/eforms/cmifpwrams
[ ] Medical Surveillance Questionnaire (All personnel to complete.) and follow-up
Chemical Safety Training: see http://www.ehs.indiana.edu/lab_safety_training.shtml
[ ] Laboratory Safety and Chemical Hygiene Training
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# 00-000-00
Name : _
Network ID: _
Position : _
Dept/Program: _
Responsibilities Check [X] all that apply.
[ ] Anesthesia
[ ] Injections
[ ] Surgery – survival
[ ] Animal Handling
[ ] Perfusion
[ ] Surgery – non-survival
[ ] Euthanasia
[ ] Peri- or post-operative monitoring
[ ] Additional Responsibilities _
Experience: List individual’s previous training and experience using animals, including species information, identifying procedures
and experience level (e.g., how many years). Include where and by whom training was provided. _
Training: Indicate who will provide current training and for which procedures. Include the qualifications of the trainer. How will skill
level and/or proficiency be determined? What are the qualifications for an individual to work independently? _
BIACUC-CITI courses: http://researchadmin.iu.edu/EO/eo_citi.html. Check [X] all that apply.
[ ] Investigators, Staff and Students, Basic Course (All personnel to complete.)
[ ] Occupational Health and Safety Training for Personnel Working with Animals (All personnel to complete.)
Check species as appropriate:
[ ] Working with Rats
[ ] Working with Dogs
[ ] Working with Hamsters
[ ] Working with Mice
[ ] Working with Rabbits
[ ] Working with Amphibians
Training by Laboratory Animal Resources Personnel:
[ ] Aseptic surgery (Required prior to participating in any surgical procedures.)
Medical Clearance to Work with animals: http://www.iuhealth.net/web/eforms/cmifpwrams
[ ] Medical Surveillance Questionnaire (All personnel to complete.) and follow-up
Chemical Safety Training: see http://www.ehs.indiana.edu/lab_safety_training.shtml
[ ] Laboratory Safety and Chemical Hygiene Training
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# 00-000-00
Name : _
Network ID: _
Position : _
Dept/Program: _
Responsibilities Check [X] all that apply.
[ ] Anesthesia
[ ] Injections
[ ] Surgery – survival
[ ] Animal Handling
[ ] Perfusion
[ ] Surgery – non-survival
[ ] Euthanasia
[ ] Peri- or post-operative monitoring
[ ] Additional Responsibilities _
Experience: List individual’s previous training and experience using animals, including species information, identifying procedures
and experience level (e.g., how many years). Include where and by whom training was provided.
_
Training: Indicate who will provide current training and for which procedures. Include the qualifications of the trainer. How will skill
level and/or proficiency be determined? What are the qualifications for an individual to work independently? _
BIACUC-CITI courses: http://researchadmin.iu.edu/EO/eo_citi.html. Check [X] all that apply.
[ ] Investigators, Staff and Students, Basic Course (All personnel to complete.)
[ ] Occupational Health and Safety Training for Personnel Working with Animals (All personnel to complete.)
Check species as appropriate:
[ ] Working with Rats
[ ] Working with Dogs
[ ] Working with Hamsters
[ ] Working with Mice
[ ] Working with Rabbits
[ ] Working with Amphibians
Training by Laboratory Animal Resources Personnel:
[ ] Aseptic surgery (Required prior to participating in any surgical procedures.)
Medical Clearance to Work with animals: http://www.iuhealth.net/web/eforms/cmifpwrams
[ ] Medical Surveillance Questionnaire (All personnel to complete.) and follow-up
Chemical Safety Training: see http://www.ehs.indiana.edu/lab_safety_training.shtml
[ ] Laboratory Safety and Chemical Hygiene Training
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# 00-000-00
Name : _
Network ID: _
Position : _
Dept/Program: _
Responsibilities Check [X] all that apply.
[ ] Anesthesia
[ ] Injections
[ ] Surgery – survival
[ ] Animal Handling
[ ] Perfusion
[ ] Surgery – non-survival
[ ] Euthanasia
[ ] Peri- or post-operative monitoring
[ ] Additional Responsibilities _
Experience: List individual’s previous training and experience using animals, including species information, identifying procedures
and experience level (e.g., how many years). Include where and by whom training was provided. _
Training: Indicate who will provide current training and for which procedures. Include the qualifications of the trainer. How will skill
level and/or proficiency be determined? What are the qualifications for an individual to work independently? _
BIACUC-CITI courses: http://researchadmin.iu.edu/EO/eo_citi.html. Check [X] all that apply.
[ ] Investigators, Staff and Students, Basic Course (All personnel to complete.)
[ ] Occupational Health and Safety Training for Personnel Working with Animals (All personnel to complete.)
Check species as appropriate:
[ ] Working with Rats
[ ] Working with Dogs
[ ] Working with Hamsters
[ ] Working with Mice
[ ] Working with Rabbits
[ ] Working with Amphibians
Training by Laboratory Animal Resources Personnel:
[ ] Aseptic surgery (Required prior to participating in any surgical procedures.)
Medical Clearance to Work with animals: http://www.iuhealth.net/web/eforms/cmifpwrams
[ ] Medical Surveillance Questionnaire (All personnel to complete.) and follow-up
Chemical Safety Training: see http://www.ehs.indiana.edu/lab_safety_training.shtml
[ ] Laboratory Safety and Chemical Hygiene Training
[return to Additional Sections]
[return to table of contents]
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