Feb. 2000

> **SAMPLE ANIMAL STUDY PROPOSAL**

### PLEASE TYPE

####  ADMINISTRATIVE DATA

  --------------- -- -- -- -- -------- ------ ------------------- -------- ------------------
  Department:                                                              

                                                                           

  Principal                                                                
  Investigator:                                                            

                                                                           

  Mailing                                                                  
  Address:                                                                 

                                                                           

  Telephone:                           Fax:                       Email:   

                                                                           

  Project Title:                                                           
  --------------- -- -- -- -- -------- ------ ------------------- -------- ------------------

Initial Submission Renewal or Modification

List the names of all individuals authorized to conduct procedures
involving animals under this proposal and identify key personnel (e.g.,
co-investigator(s), providing their department, telephone, fax, and
email:

Funding Source:

#### ANIMAL REQUIREMENTS

  ----------------- -- -- -- ---------- ------------- ----------------- ----------------- ------------- ---------- ------ ----- ---- ---------- ------ ------------- ------------ -----------------
  Genus:                     *\[e.g.,                                                                                                Species:          *\[e.g.,                   
                             Mus\]*                                                                                                                    musculus\]*                

                                                                                                                                                                                  

  Strain,                                                                                               *\[e.g.,                     Common                          *\[e.g.,     
  subspecies, or                                                                                        C57BL\]*                     name:                           black        
  breed:                                                                                                                                                             laboratory   
                                                                                                                                                                     mouse\]*     

                                                                                                                                                                                  

  Approximate age,                                                                                                                                                                
  weight or size:                                                                                                                                                                 

                                                                                                                                                                                  

  Sex:                                                                                                                                                                            

                                                                                                                                                                                  

  Bacteriological                                                       *\[e.g., germfree                                                                                         
  status:                                                               (axenic), defined                                                                                         
                                                                        flora                                                                                                     
                                                                        (gnotobiotic),                                                                                            
                                                                        specific pathogen                                                                                         
                                                                        free,                                                                                                     
                                                                        conventional\]*                                                                                           

                                                                                                                                                                                  

  Viral status:                                       *\[e.g., simian                                                                                                             
                                                      immunodeficency                                                                                                             
                                                      virus, simian                                                                                                               
                                                      retrovirus\]*                                                                                                               

                                                                                                                                                                                  

  Source(s):                            *\[e.g., name                                                                                                                             
                                        of vendor or                                                                                                                              
                                        breeder, bred                                                                                                                             
                                        in-house\]*                                                                                                                               

                                                                                                                                                                                  

  Primary housing                                                                         *\[Facility                                                                             
  location(s):                                                                            manager must                                                                            
                                                                                          certify below                                                                           
                                                                                          that facility                                                                           
                                                                                          has the                                                                                 
                                                                                          resource                                                                                
                                                                                          capability to                                                                           
                                                                                          support the                                                                             
                                                                                          study. If                                                                               
                                                                                          animals will                                                                            
                                                                                          be housed in                                                                            
                                                                                          lab or                                                                                  
                                                                                          anywhere else                                                                           
                                                                                          outside                                                                                 
                                                                                          central                                                                                 
                                                                                          facility for                                                                            
                                                                                          more than 12                                                                            
                                                                                          hours,                                                                                  
                                                                                          provide                                                                                 
                                                                                          building and                                                                            
                                                                                          room                                                                                    
                                                                                          number.\]*                                                                              

                                                                                                                                                                                  

  Location(s) where                                                                                                                                                               
  manipulation will                                                                                                                                                               
  be conducted:                                                                                                                                                                   

                                                                                                                                                                                  

  Number of Animals                                                                                                                                                               
  to be Used:                                                                                                                                                                     

  Year 1:                                                                                                          Year                         Year                              
                                                                                                                   2:                           3:                                

  Total:                                                                                                                                                                          
  ----------------- -- -- -- ---------- ------------- ----------------- ----------------- ------------- ---------- ------ ----- ---- ---------- ------ ------------- ------------ -----------------

#### TRANSPORTATION

Transportation of animals must conform to all institutional
guidelines/policies and federal regulations. If animals will be
transported on public roads or out of state, describe efforts to comply
with USDA regulations. If animals will be transported between
facilities, describe the methods and containment to be utilized. If
animals will be transported within a facility, include the route and
elevator(s) to be utilized.

#### STUDY OBJECTIVES

Briefly explain in language understandable to a layperson the aim of the
study and why the study is important to human or animal health, the
advancement of knowledge, or the good of society.

####  RATIONALE FOR ANIMAL USE (Use additional sheets if necessary.)

1\) Explain your rationale for animal use*. \[The rationale should
include reasons why non-animal models cannot be used.\]*

2\) Justify the appropriateness of the species selected. *\[The species
selected should be the lowest possible on the phylogenetic scale.\]*

3\) Justify the number of animals to be used. \[The number of animals
should be the minimum number required to obtain statistically valid
results.\]

#### DESCRIPTION OF EXPERIMENTAL DESIGN AND ANIMAL PROCEDURES 

> (Use additional sheets if necessary.)

Briefly explain the experimental design and specify all animal
procedures. This description should allow the IACUC to understand the
experimental course of an animal from its entry into the experiment to
the endpoint of the study. Specifically address the following:

-   **Experimental injections or inoculations** (substances, e.g.,
    infectious agents, adjuvants, etc.; dose, sites, volume, route, and
    schedules).

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-   **Blood withdrawals** (volume, frequency, withdrawal sites, and
    methodology).

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-   **Surgical procedures** (provide details of survival and
    non-survival surgical procedures in Section G.).

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-   **Radiation** (dosage and schedule)**.**

-   **Methods of restraint** (e.g., restraint chairs, collars, vests,
    harnesses, slings, etc.). Include how animals are restrained for
    routine procedures like blood withdrawals. Prolonged restraint must
    be justified with appropriate oversight to ensure it is minimally
    distressing. Describe any sedation, acclimation or training to be
    utilized.

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-   **Animal identification methods** (e.g., ear tags, tattoos, collar,
    cage card, implant, etc.).

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-   **Other procedures** (e.g., survival studies, tail biopsies, etc.).

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-   **Resultant effect**s, if any, that the animals are expected to
    experience (e.g., pain or distress, ascites production, etc.).

-   **Other potential stressors** (e.g., food or water deprivation,
    noxious stimuli, environmental stress) **and procedures to monitor
    and minimize distress**. If a study is USDA Classification E,
    indicate any non-pharmaceutical methods to minimize pain and
    distress.

-   **Experimental endpoint criteria** (e.g., tumor size, percentage
    body weight gain or loss, inability to eat or drink, behavioral
    abnormalities, clinical symptomatology, or signs of toxicity) must
    be specified when the administration of tumor cells, biologics,
    infectious agents, radiation or toxic chemicals are expected to
    cause significant symptomatology or are potentially lethal. List the
    criteria to be used to determine when euthanasia is to be performed.
    Death as an endpoint must always be scientifically justified.

-   **Veterinary care** (indicate desired plan of action in case of
    animal illness, e.g., initiate treatment, call investigator prior to
    initiating treatment, euthanize).

#### SURGERY

If proposed, complete the following: (Use additional sheets if
necessary.)

1.  Identify and describe the surgical procedure(s) to be performed.
    Include preoperative procedures (e.g., fasting, analgesic loading),
    and monitoring and supportive care during surgery. Include the
    aseptic methods to be utilized.

2.  Who will perform surgery and what are their qualifications and/or
    experience?

3.  Where will surgery be performed and postoperative care provided
    (building and rooms)?

4.  If survival surgery, describe postoperative care required, frequency
    of observation, and identify the responsible individual(s). Include
    detection and management of postoperative complications during work
    hours, after hours, weekends and holidays.

5.  If non-survival surgery, describe how humane euthanasia is enacted
    and how death is determined.

6\. Are paralytic agents used during surgery? If yes, please describe
how ventilation will be maintained and how pain will be assessed.

7.  Has major survival surgery been performed on any animal prior to
    being placed on this study? *\[Major survival surgery penetrates and
    exposes a body cavity or produces substantial impairment of physical
    or physiologic functions (such as laparotomy, thoracotomy,
    crainotomy, joint replacement, or limb amputation).\]*

> If yes, please explain:

8.  Will more than one major survival surgery be performed on an animal
    while on this study?

> If yes, please justify:

#### H. PAIN OR DISTRESS CLASSIFICATION AND CONSIDERATION OF ALTERNATIVES {#h.-pain-or-distress-classification-and-consideration-of-alternatives .unnumbered}

####   {#section .unnumbered}

#### 1. Pain or Distress Classification  {#pain-or-distress-classification .unnumbered}

+-----------------+-----------+--------+--------+--------+-----------+
| **Species**     | **USDA    | **     |        |        | **3 year  |
|                 | Classific | Number |        |        | total     |
| (common name)   | ation**\* | of     |        |        | number of |
|                 |           | a      |        |        | animals** |
|                 | **B, C, D | nimals |        |        |           |
|                 | or E**    | used   |        |        |           |
|                 |           | each   |        |        |           |
|                 |           | year** |        |        |           |
+-----------------+-----------+--------+--------+--------+-----------+
|                 |           | **Year | **Year | **Year |           |
|                 |           | 1**    | 2**    | 3**    |           |
+-----------------+-----------+--------+--------+--------+-----------+
|                 |           |        |        |        |           |
+-----------------+-----------+--------+--------+--------+-----------+
|                 |           |        |        |        |           |
+-----------------+-----------+--------+--------+--------+-----------+
|                 |           |        |        |        |           |
+-----------------+-----------+--------+--------+--------+-----------+
|                 |           |        |        |        |           |
+-----------------+-----------+--------+--------+--------+-----------+
|                 |           |        |        |        |           |
+-----------------+-----------+--------+--------+--------+-----------+
|                 |           |        |        |        |           |
+-----------------+-----------+--------+--------+--------+-----------+
| **Total number  |           |        |        |        |           |
| of animals      |           |        |        |        |           |
| (should equal   |           |        |        |        |           |
| total from      |           |        |        |        |           |
| Section B):**   |           |        |        |        |           |
+-----------------+-----------+--------+--------+--------+-----------+

**\* USDA Classifications and Examples**

**Classification B:** Animals being bred, conditioned, or held for use
in teaching, testing, experiments, research, or surgery, but not yet
used for such purposes.

**Examples:**

-   Breeding colonies of any animal species (USDA does not require
    listing of rats, mice, birds) that are held in legal sized caging
    and handled in accordance with the *Guide* and other applicable
    regulations. Breeding colony includes parents and offspring.

-   Newly acquired animals that are held in proper caging and handled in
    accordance with applicable regulations.

-   Animals held under proper captive conditions or wild animals that
    are being observed.

**Classification C:** Animals upon which teaching, research,
experiments, or tests will be conducted involving no pain, distress, or
use of pain-relieving drugs.

**Examples:**

-   Procedures performed correctly by trained personnel such as the
    administration of electrolytes/fluids, administration of oral
    medication, blood collection from a common peripheral vein per
    standard veterinary practice (dog cephalic, cat jugular) or
    catheterization of same, standard radiography, parenteral injections
    of non-irritating substances.

-   Euthanasia performed in accordance with the recommendations of the
    most recent AVMA Panel on Euthanasia, utilizing procedures that
    produce rapid unconsciousness and subsequent humane death.

-   Manual restraint that is no longer than would be required for a
    simple exam; short period of chair restraint for an adapted nonhuman
    primate.

**Classification D:** Animals upon which experiments, teaching,
research, surgery, or tests will be conducted involving accompanying
pain or distress to the animals and for which appropriate anesthetic,
analgesic, or tranquilizing drugs will be used.

**Examples:**

-   Surgical procedures conducted by trained personnel in accordance
    with standard veterinary practice such as biopsies, gonadectomy,
    exposure of blood vessels, chronic catheter implantation, laparotomy
    or laparoscopy.

-   Blood collection by more invasive routes such as intracardiac or
    periorbital collection from species without a true orbital sinus
    such as rats and guinea pigs.

-   Administration of drugs, chemicals, toxins, or organisms that would
    be expected to produce pain or distress but which will be alleviated
    by analgesics.

**Classification E:** Animals upon which teaching, experiments,
research, surgery, or tests will be conducted involving accompanying
pain or distress to the animals and for which the use of appropriate
anesthetic, analgesic, or tranquilizing drugs will adversely affect the
procedures, results, or interpretation of the teaching, research,
experiments, surgery, or tests.

**Examples:**

-   Procedures producing pain or distress unrelieved by analgesics such
    as toxicity studies, microbial virulence testing, radiation
    sickness, and research on stress, shock, or pain.

-   Surgical and postsurgical sequella from invasion of body cavities,
    orthopedic procedures, dentistry or other hard or soft tissue damage
    that produces unrelieved pain or distress.

-   Negative conditioning via electric shocks that would cause pain in
    humans.

-   Chairing of nonhuman primates not conditioned to the procedure for
    the time period used.

**NOTE REGARDING CLASSIFICATION E:** An explanation of the procedures
producing pain or distress in these animals and the justification for
not using appropriate anesthetic, analgesic or tranquilizing drugs must
be provided on **Attachment 1**. This information is required to be
reported to the USDA, will be available from USDA under the Freedom of
Information Act, and may be publicly available through the Internet via
USDA's website.

2\. Consideration of Alternatives

If any procedures fall into USDA\'s Classification D or E, causing more
than momentary or slight pain or distress to the animals, describe your
consideration of alternatives and your determination that alternatives
are not available. Delineate the methods and sources used in the search.
Database references must include databases searched, the date of the
search, period covered, and the keywords used. Alternatives include
methods that (1) refine existing tests by minimizing animal distress,
(2) reduce the number of animals necessary for an experiment, or (3)
replace whole‑animal use with in vitro or other tests. When ascites
production is used to produce antibodies, justification needs to be
given as to why in vitro systems cannot be used. Note that you must
certify in Section Q.5. that no valid alternative was identified to any
described procedures which may cause more than momentary pain or
distress, whether relieved or not.

**I. ANESTHESIA, ANALGESIA, TRANQUILIZATION, OTHER AGENTS**

For animals indicated in Section H.1., Classification D, specify the
anesthetics, analgesics, sedatives or tranquilizers that are to be used.
Include the name of the agent(s), the dosage, route and schedule of
administration. If information is provided in Section G. above, please
cross-reference. Describe tracking and security of controlled drugs
(Drug Enforcement Agency requirements).

**J. METHOD OF EUTHANASIA OR DISPOSITION OF ANIMALS AT END OF STUDY**

Indicate the proposed method of euthanasia. If a chemical agent is used
specify the dosage and route of administration. If the method(s) of
euthanasia include those **not** recommended by the AVMA Panel Report on
Euthanasia (e.g., decapitation or cervical dislocation without
anesthesia), provide scientific justification why such methods must be
used. Indicate the method of carcass disposal if not described in
Section K. below.

**K. HAZARDOUS AGENTS**

Use of hazardous agents requires the approval of the institutional
Biosafety Office/Committee. Attach documentation of approval for the use
of recombinant DNA or potential human pathogens.

  --------------------- --------- -------- ------------ -------------------- ------------
  **Hazardous Agent**   **Yes**   **No**   **Agent**    **Date of Biosafety  **Tracking
                                                        Approval**           \#**

  Radionuclides                                                              

  Biological Agents                                                          

  Hazardous Chemicals                                                        
  or Drugs                                                                   

  Recombinant DNA                                                            
  --------------------- --------- -------- ------------ -------------------- ------------

Study Conducted at Animal Biosafety Level: 1 2 3 4

Describe the practices and procedures required for the safe handling and
disposal of contaminated animals and material associated with this
study. Also describe methods for removal of radioactive waste and, if
applicable, the monitoring of radioactivity.

Additional safety considerations:

**L. BIOLOGICAL MATERIAL/ANIMAL PRODUCTS FOR USE IN ANIMALS**

> (e.g., cell lines, antiserum, etc.)

1.  Specify Material:

2\. Source: Material Sterile or Attenuated: Yes No

> If derived from rodents, has the material been MAP/RAP/HAP tested*?
> \[MAP - Mouse Antibody Production; RAP - Rat Antibody Production;
> HAP - Hamster Antibody Production\]*

Yes (Attach copy of results) or No

3.  I certify that the MAP/RAP/HAP tested materials to be used have not
    been passed through rodent species outside of the animal facility in
    question and/or the material is derived from the original MAP tested
    sample. To the best of my knowledge the material remains
    uncontaminated with rodent pathogens.

> **Initials of Principal Investigator.**

**M. TRANSGENIC AND KNOCKOUT ANIMALS**

####  {#section-1 .unnumbered}

#### Describe any phenotypic consequences of the genetic manipulations to the animals. Describe any special care or monitoring that the animals will require.  {#describe-any-phenotypic-consequences-of-the-genetic-manipulations-to-the-animals.-describe-any-special-care-or-monitoring-that-the-animals-will-require. .unnumbered}

**N. EXEMPTIONS FROM ENVIRONMENTAL ENHANCEMENT FOR NONHUMAN PRIMATES OR
EXERCISE FOR DOGS**

> 1\. For nonhuman primates, are you seeking an exemption for scientific
> reasons from the institution's plan for environment enhancement? Yes
> or No If yes, provide the basis of the request.
>
> 2\. For dogs, are you seeking an exemption for scientific reasons from
> the institution's plan to provide dogs with the opportunity for
> exercise? Yes or No If yes, provide the basis of the request.

O.  **FIELD STUDIES**

> If animals in the wild will be used, describe how they will be
> observed, any interactions with the animals, whether the animals will
> be disturbed or affected, and any special procedures anticipated.
> Indicate if Federal permits are required and whether they have been
> obtained.

P.  **SPECIAL CONCERNS OR REQUIREMENTS OF THE STUDY**

List any special housing, equipment, animal care (e.g., special caging,
water, feed, or waste disposal, environmental enhancement, etc.).

Q.  **PRINCIPAL INVESTIGATOR CERTIFICATIONS**

1\. I certify that I have attended the institutionally required
investigator training course.

  --------------------- -------------- ----------- --------------------------
  Year of Course                       Location:   
  Attendance:                                      

  --------------------- -------------- ----------- --------------------------

2\. I certify that I have determined that the research proposed herein
is not unnecessarily duplicative of previously reported research.

3\. I certify that all individuals working on this proposal who are at
risk are participating in the Institution\'s Occupational Health and
Safety Program.

4\. I certify that the individuals listed in Section A. are authorized
to conduct procedures involving animals under this proposal, have
attended the institutionally required investigator training course, and
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,
analgesics, and tranquilizers (if necessary); and procedures for
reporting animal welfare concerns.

5\. For all USDA Classification D and E proposals (see section
H.1.)**:** I certify that I have reviewed the pertinent scientific
literature and the sources and/or databases as noted in Section H.2. 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.

6.  I certify that I will obtain approval from the IACUC before
    initiating any significant changes in this study.

7.  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.

8.  I certify that I am familiar with and will comply with all pertinent
    institutional, state, and federal rules and policies.

**Principal Investigator:**

  --------------------------- ------------ ------------------ ------- -----------
  Name:                       Signature:                      Date:   

  --------------------------- ------------ ------------------ ------- -----------

**R. CONCURRENCES**

**PROPOSAL NUMBER \_\_\_\_\_\_\_\_\_\_\_\_\_** (leave blank)

Supervisory concurrence as applicable:

  ------- --------------------- ------------ ------------------- ------- -----------
  Name:                         Signature:                       Date:   

  ------- --------------------- ------------ ------------------- ------- -----------

Safety Office/Committee Certification of Review and Concurrence:

(Required of all studies utilizing hazardous agents.)

  ------- --------------------- ------------ ------------------- ------- -----------
  Name:                         Signature:                       Date:   

  ------- --------------------- ------------ ------------------- ------- -----------

Facility Manager/Veterinarian certification of resource capability in
the indicated facility to support the proposed study:

  ----------- -- ------- ------- ------------- ------------ -------------- ------- --------
  Facility:              Name:                 Signature:                  Date:   

  Facility:              Name:                 Signature:                  Date:   

                                                                                   

  Comments:                                                                        
  ----------- -- ------- ------- ------------- ------------ -------------- ------- --------

Attending Veterinarian certification of review and consultation on
proper use of anesthetics and pain relieving medications for any painful
procedures:

  ------- --------------------- ------------ ------------------- ------- -----------
  Name:                         Signature:                       Date:   

  ------- --------------------- ------------ ------------------- ------- -----------

**S. FINAL APPROVAL:**

Certification of review and approval by the Institutional Animal Care
and Use Committee:

  ------- --------------------- ------------ ------------------- ------- -----------
  Name:                         Signature:                       Date:   

  ------- --------------------- ------------ ------------------- ------- -----------

List any attachments here:

**Attachment 1**

**Explanation for USDA Classification E**

(This report is required to accompany USDA Form 7023 to support any USDA
Classification E listings.)

This document must be typed.

Name of investigator:

Animal Study Proposal Title:

Species and number of animals listed in Classification E for each year:

Species:

Number of animals:

year 1 -

year 2 -

year 3 -

Total:

Description of project including reason(s) for species selection:

Provide a scientific justification to explain why the use of
anesthetics, analgesics, sedatives or tranquilizers during and/or
following painful or distressing procedures is contraindicated:

Signature of investigator:

Date:

Signature of IACUC Chairperson:

Date: