APPENDIX A

*For IACUC Use Only: IACUC No.: Date of Approval:*

*Rev 3: April 2004*

Check all that apply:

Maj. Surv. Surgery Primates Cat. E studies Haz. Agents Dogs, cats or
pigs

**[Animal Component of Research Protocol]{.smallcaps}** **(ACORP)**

**[General Information]{.underline}**

**Note: Use a separate form for each species.** **DO NOT include
individual appendices if they are not relevant to the protocol being
described. Type an "x" in the box(es) next to your selection(s**).
**[Define all abbreviations the first time they are used.]{.underline}
To add a row to a table, click inside one of the existing table cells,
then select Table, Insert, Rows from the main menu of the program.**

A. **ACORP Status.** Complete items A.1.- A.8. below; then proceed to
item B.

1.  Name of Principal Investigator: **     **

2.  VA Station Name and Number: **     **

3.  Proposal Title: **     **

4.  Animal Species covered by this ACORP ([only one]{.underline}):
    **     **

5.  Funding Source. Indicate the source(s) of funds that will be used to
    perform these animal procedures once approved by the VA IACUC:

Department of Veterans Affairs

U. S. Public Health Service (e.g. NIH)

Private or Charitable Foundation. Identify: **     **

University Departmental Funds. Identify University and Department:
**     **

Private Company. Identify: **     **

Other. Identify: **     **

6.  Is this a new ACORP for a new project?

Yes. Proceed to item 7.

No. Answer A.6.a.-c. below.

> a\. Indicate the status of this ACORP below:
>
> This is an unchanged, approved ACORP intended for a new funding
> source.
>
> This is a revised ACORP with a new funding source.
>
> This is a revised ACORP that reflects changes or additional, new
> studies.
>
> This ACORP is submitted as a three-year (3-year) renewal.
>
> Other. Please specify: **     **
>
> b. Previous ACORP title: **     **
>
> c. Previous IACUC approval number (VA and affiliate, if applicable):
> **     **

7.  Do you plan on performing the animal procedures described in this
    form even if you do not receive extramural VA, PHS, NSF, or other
    funding?

Yes.

No.

8.  Indicate the type of animal use:

Research.

Teaching or Training.

Testing.

Sentinel animal use.

Breeding and colony management only; no experimental procedures.

Other. Please specify: **     **

## Proposal Overview

B. Using non-technical (lay) language that a [senior high school
student]{.underline} would understand, briefly describe how this
research project might improve the health of people and/or other
animals. A scientific abstract from a grant proposal is not acceptable.
Once completed, proceed to item C. **     **

C. **Experimental Design.**

1.  Using non-technical (lay) language that a [senior high
    school]{.underline} student would understand, describe the
    experimental design in no more than one or two paragraphs. **     **

> 2\. In language scientific colleagues [outside]{.underline} of your
> discipline would understand, describe the experimental design for the
> animal experiments planned, and the sequence of events to reveal what
> happens to the animals. Include all procedures and manipulations, and
> explain why they must be performed. Give your best estimate of how
> many animals will undergo the procedures or manipulations described.
> For complicated experimental designs, a flow chart, diagram, or table
> is strongly recommended to help the IACUC understand what is proposed.
> Do not describe the details of surgical procedures, the use of rodents
> for breeding, monoclonal antibody production, or behavioral training
> here. Such details are requested later in appendices. Once completed,
> proceed to item D. **     **

D. Describe the characteristics of the selected species, strain, stock,
mutant, or breed that justify its use in the proposed study. Consider
such characteristics as body size, species, strain, breed, availability,
data from previous studies, and unique anatomic or physiologic features.
Once completed, proceed to item E. **     **

**[Personnel]{.underline}**

E. Give the names of all research staff expected to work with the
animals in this study. For each person listed, describe their education,
training, and experience with experimental animals in general AND
describe their experience performing the exact procedures in the species
described [in this ACORP]{.underline}. This description must help IACUC
members determine if all animal manipulations, including surgery,
testing, and blood collection, are performed by individuals who are
qualified to accomplish the procedures skillfully and humanely. A
listing of academic degrees alone is [not]{.underline} an adequate
response. (Qualifications to perform euthanasia will be requested in
item U.3. and need not be given here.) Once completed, proceed to item
F. **     **

F. If personnel do not have experience with the exact procedures
described in this ACORP, how will they be trained, who will train them,
and what are the training experiences or qualifications of the person(s)
doing the training? If not applicable, enter "N/A". Once completed,
proceed to item G. **     **

G. **Occupational Safety and Health.**

1\. Have all personnel listed in item E. been enrolled in the
Occupational Health and Safety Program for those with laboratory animal
contact?

Yes. Proceed to item G.2.

No. If personnel have declined to participate, are enrolled in another
equivalent program, or will enroll before studies commence, so indicate
here and then proceed to item G.2. **     **

2\. Are there any non-routine measures such as special vaccines or
additional health screening techniques that would potentially benefit
research, husbandry, or veterinary staff participating in or supporting
this project? Routine measures included in the Occupational Health and
Safety Program (vaccination for tetanus, rabies, and hepatitis B, and TB
screening) need not be mentioned here.

Yes. Describe them below; then proceed to item H. **     **

No. Proceed to item H.

**[Animal Information]{.underline}**

H. Complete the following table; then proceed to item I.

  ------------- ------------ --------------- --------------- --------------
  Strain,       Gender       Age/Size        Source (Vendor) Health
  Stock,                                                     Status\*
  Mutant, or                                                 
  Breed                                                      

  **     **     **     **    **     **       **     **       **     **
  ------------- ------------ --------------- --------------- --------------

> \*For each strain, stock, mutant, or breed listed, provide information
> about the expected status of the animals:
>
> -For rodents and rabbits, indicate specific-pathogen-free (SPF),
> gnotobiotic (germ-free or defined flora), conventional, feral, or
> other description.
>
> -For dogs, cats, pigs, and other "large animals", indicate
> specific-pathogen-free (SPF), conditioned, conventional, feral, or
> other description.
>
> -For non-human primates, indicate viral status (e.g., herpes B, SIV,
> etc.)
>
> -Also indicate here if animals will be surgically altered by the
> vendor (e.g., ovariectomized rats).

I. Complete the tables below, assigning all requested animals by
breed/strain/mutant to a USDA category of pain/distress. If you have
difficulty determining the appropriate category, please contact the
attending veterinarian or IACUC Chair for assistance. [The same animal
cannot be assigned to more than one USDA category]{.underline}. If
several different procedures are planned, the animal should be placed in
a category based on the most painful/distressful procedure. You are
required by VA policy to describe planned procedures for the fourth and
fifth years of a submitted VA grant even though, under PHS policy, the
IACUC must perform a new review three years after the initial approval
date. Once completed, proceed to item J.

  --------------------------- ----------- ----------- ----------- ----------- -----------
  **[USDA Category                                                            
  B]{.underline}:** List by                                                   
  year the number of animals                                                  
  that will be bred or                                                        
  purchased for breeding, but                                                 
  not used for experiments.                                                   
  This includes breeders,                                                     
  young that cannot be used                                                   
  because of improper                                                         
  genotype or gender, and any                                                 
  other animals that [will                                                    
  not]{.underline} have any                                                   
  research procedures                                                         
  performed on them or                                                        
  participate in research                                                     
  studies. If numbers cannot                                                  
  be determined exactly,                                                      
  estimate as closely as                                                      
  possible. (Note: If tail                                                    
  snips are necessary for                                                     
  genotyping, this category                                                   
  is not appropriate.)                                                        

  Breed/Strain/Mutant         Year 1      Year 2      Year 3      Year 4      Year 5

  **     **                   **     **   **     **   **     **   **     **   **     **

  **[USDA Category                                                            
  C]{.underline}:** List, by                                                  
  year the number of animals                                                  
  that will undergo                                                           
  procedures that involve no                                                  
  or only very brief pain or                                                  
  distress, with no need for                                                  
  or use of pain relieving                                                    
  drugs. Examples include                                                     
  observational studies, most                                                 
  intravenous and parenteral                                                  
  injections of                                                               
  non-irritating agents, most                                                 
  blood collections from                                                      
  peripheral vessels, and the                                                 
  collection of cells and/or                                                  
  tissues from animals                                                        
  [after]{.underline}                                                         
  euthanasia has been                                                         
  performed.                                                                  

  Breed/Strain/Mutant         Year 1      Year 2      Year 3      Year 4      Year 5

  **     **                   **     **   **     **   **     **   **     **   **     **

  **[USDA Category                                                            
  D]{.underline}:** List by                                                   
  year the number of animals                                                  
  that will undergo                                                           
  procedures involving                                                        
  potential pain or distress                                                  
  that is relieved by                                                         
  appropriate anesthetics,                                                    
  sedatives, or analgesics.                                                   
  Examples include major and                                                  
  minor surgery performed                                                     
  under anesthesia (survival                                                  
  or non-survival), tissue or                                                 
  organ collections [prior                                                    
  to]{.underline} euthanasia,                                                 
  painful procedures                                                          
  performed under anesthesia                                                  
  (such as retro-orbital                                                      
  blood collection in                                                         
  rodents), prolonged                                                         
  restraint accompanied by                                                    
  tranquilizers or sedatives,                                                 
  and experiments involving                                                   
  infectious or other                                                         
  hazardous materials in                                                      
  animals that have                                                           
  provisions for immediate                                                    
  euthanasia if they become                                                   
  sick to effectively prevent                                                 
  pain and/or suffering. If                                                   
  an endpoint is used that                                                    
  involves significant pain                                                   
  or distress, consideration                                                  
  should be given to putting                                                  
  animals into Category E.                                                    

  Breed/Strain/Mutant         Year 1      Year 2      Year 3      Year 4      Year 5

  **     **                   **     **   **     **   **     **   **     **   **     **

  **[USDA Category                                                            
  E:]{.underline}** List, by                                                  
  year, the number of animals                                                 
  that will undergo                                                           
  procedures in which pain or                                                 
  stress is NOT relieved with                                                 
  the use of anesthetics,                                                     
  analgesics, tranquilizers,                                                  
  or by euthanasia. Examples                                                  
  include studies in which                                                    
  animals are allowed to die                                                  
  without intervention (e.g.                                                  
  LD~50~, mortality as an                                                     
  end-point), studies that                                                    
  allow endpoints that are                                                    
  painful or stressful,                                                       
  addictive drug withdrawals                                                  
  without treatment, pain                                                     
  research, and noxious                                                       
  stimulation.                                                                

  Breed/Strain/Mutant         Year 1      Year 2      Year 3      Year 4      Year 5

  **     **                   **     **   **     **   **     **   **     **   **     **

  **[TOTALS]{.underline}:**                                                   
  Bring all totals for each                                                   
  year down, by                                                               
  breed/strain/mutant.                                                        

  Breed/Strain/Mutant         Year 1      Year 2      Year 3      Year 4      Year 5

  **     **                   **     **   **     **   **     **   **     **   **     **
  --------------------------- ----------- ----------- ----------- ----------- -----------

J. **Description of USDA Category D and E procedures**. Are any USDA
Category D or E studies planned?

> No. Proceed to item K.

Yes. Complete items J.1. and J.2.; then proceed to item K.

1\. List and describe all category D procedures by filling out the table
below. If no category D studies are proposed, enter "N/A" and proceed to
item J.2. [For any surgical procedures you will describe in Appendix 5,
enter only a brief description in the "Procedure" column, then enter
"See Appendix 5 for details."]{.underline}

  ------------------- ------------------ ---------------- ----------------
  Procedure           Frequency of       Person(s) doing  Analgesic,
                      monitoring after   the monitoring   sedative, or
                      the procedure and                   anesthetic used,
                      how long animals                    plus dose,
                      will be monitored                   route, and
                                                          duration

  **     **           **     **          **     **        **     **

  **     **           **     **          **     **        **     **

  **     **           **     **          **     **        **     **
  ------------------- ------------------ ---------------- ----------------

2.  Each year a report describing and justifying all category E
    procedures must be submitted by each facility to the USDA and the
    VA. If no category E studies are proposed, enter "N/A" and proceed
    to item K. Otherwise, describe each category E procedure, and
    justify completely why pain or distress relief cannot be provided
    for each procedure. Your description will be used in the USDA annual
    report. If animals will be allowed to experience natural death as a
    result of experimental procedures (e.g. infectious disease or
    oncology studies), or an endpoint is used that allows the animals to
    experience significant pain or distress, you must justify why an
    alternate endpoint (such as weight loss, clinical signs, tumor size,
    etc.) prior to death or pain or distress can not be used. If animals
    will undergo category D procedures as well, describe them in item
    J.1. above. **     **

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K.  Describe how the estimated number of animals needed for the
    experiments was determined. When appropriate, provide the number and
    type of experimental and control groups in each experiment, the
    number of experiments planned, and the number of animals in each
    group. The ILAR *Guide* states that whenever possible, the number of
    animals requested should be justified statistically. A power
    analysis is strongly encouraged to justify group sizes when
    appropriate. Once completed, proceed to item L. **     **

**[Animal Housing and Care]{.underline}**

L. **Laboratory Animal Veterinary Support**. Complete items L.1-L.3,
then proceed to item M.

1\. Give the name of the laboratory animal veterinarian responsible for
providing adequate care to the animals that will be used along with
their institutional affiliation. **     **

> 2\. VA Policy requires that a laboratory animal veterinarian be
> consulted [during the planning stages]{.underline} of any procedure
> involving laboratory animals, before IACUC review. Give the name of
> the laboratory animal veterinarian consulted during the planning of
> procedures involving animals. As an alternative to an actual meeting,
> the veterinarian may perform a pre-review of the ACORP and provide
> comments to the PI so that the ACORP may be revised prior to IACUC
> review. **     **

3.  Give the date of the veterinary consultation (meeting date, or date
    written comments were provided by the veterinarian to the PI).
    **     **

M. **Husbandry.**

1\. Caging needs. To help the animal care staff with caging needs,
please indicate the type of caging that you will need; then go on to
question M.2:

> Gnotobiotic (germ-free and defined flora) isolators
>
> Biohazard or other special hazard containment caging
>
> Sterile rodent microisolato[r]{.underline} caging, with filtered cage
> top
>
> Non-sterile rodent microisolator caging, with filtered cage top
>
> Standard rodent shoebox caging [with no filter top]{.underline}
>
> Standard non-rodent caging, appropriate for species
>
> Other. Describe: **     **
>
> 2\. The ILAR *Guide for the Care and Use of Laboratory Animals* states
> that consideration should be given to housing social animals in groups
> whenever possible. Will social animals be housed singly?
>
> Yes. Complete item M.3.
>
> No. Proceed to item M.4.
>
> Not Applicable; the species involved is not a social animal. Proceed
> to item M.4.

4.  Please provide a justification for housing social animals singly;
    then proceed to question M.4. **     **

> 4\. The ILAR *Guide for the Care and Use of Laboratory Animals*
> recommends the use of contact bedding (i.e., shoebox or microisolator
> cages) instead of wire mesh floors for housing rodents. Will rodents
> be housed on suspended wire mesh floors or other flooring in which the
> animals do not rest on bedding?
>
> Not applicable; this ACORP does not describe rodent use. Proceed to
> item M.6.
>
> No. All rodents will be housed in shoebox or other caging in which the
> animals rest directly on bedding. Proceed to item M.6.
>
> Yes. Proceed to item M.5.

5.  Why is caging with wire mesh flooring necessary? **     **

> 6\. Indicate the appropriate response below:
>
> This ACORP does not address the use of dogs, primates, or transgenic
> mice. Proceed to item M.7.
>
> This ACORP addresses the use of dogs. Answer item M.6.a. below.
>
> This ACORP addresses the use of primates. Answer item M.6.b. below.
>
> This ACORP addresses the use of transgenic mice. Answer item M.6.c.
> below.

a\. Is there any scientific justification for excluding the dogs in this
study from the institutional dog exercise plan required by USDA?

> No. Proceed to item M.7.
>
> Yes. Provide a scientific justification for excluding the dogs; then
> proceed to item M.7. **     **

b\. Is there any scientific justification for excluding the primates
from the institutional primate psychological enrichment plan required by
USDA?

> No. Proceed to item M.7.
>
> Yes. Provide a scientific justification below for excluding the
> primates; then proceed to item M.7. **     **

c\. Do the transgenic mice planned for use exhibit any characteristic
clinical signs or abnormal behavior related to their genotype?

> No. Proceed to item M.7.
>
> Yes. Describe here, then proceed to item M.7.: **     **
>
> 7\. Will any cannulae, acrylic implants, venous catheters, or other
> similar medical devices be implanted into an animal such that the
> device extends chronically through the skin?
>
> No. Proceed to item N.
>
> Yes. Explain what wound management measures will be taken to minimize
> the chances of chronic infections around the device(s) where they
> penetrate the skin. **     **

N. **Housing Sites**.

> 1\. Will all animals purchased with VA or VA Foundation funds be
> housed only in VA facilities?
>
> Yes. Proceed to item N.2.
>
> No. Complete and attach ACORP Appendix 1, "Use of Non-VA Animal
> Facility", then go to item N.2.

2.  Give the VA location(s), inside or outside of the animal facility,
    where animals will be housed permanently or temporarily, then
    proceed to item O. **     **

> **[Experimental Procedures]{.underline}**

O. **Rodent Breeding Policy.** Will rodents be used for the purpose of
breeding?

> No. Proceed to item P.

Yes. Complete and attach Appendix 9, "Rodent Breeding;" then proceed to
item P.

P. **Antibody Production.** Will animals be used to produce monoclonal
or polyclonal antibodies, or will existing hybridoma cell lines be
injected into animals to harvest antibody?

> No. Proceed to item Q.
>
> Yes. Complete and attach Appendix 2, "Antibody Production;" then
> proceed to item Q.

Q. **Test Substances.** Will test substances be administered to animals?
For the purposes of this question, test substances are defined as
materials administered to animals. This includes, but is not limited to,
radioisotopes, toxins, antigen, pharmacological agents, infectious
agents, carcinogens or mutagens, biomaterials, prosthetic devices, and
cells, tissues, or body fluids. [(Note:]{.underline} The following
substances do not need to be entered in Appendix 3 [unless they are
hazardous]{.underline}: routine pre- or post-operative drugs described
in the Surgery Appendix \[Appendix 5\], antigens, adjuvants, hybridomas
described in the Antibody Production Appendix \[Appendix 2\], and
euthanasia agents entered in item V, Euthanasia.)

> No. Proceed to item R.
>
> Yes. Complete and attach Appendix 3, "Test Substances;" then proceed
> to item R.

R. **Location of procedures.** Complete the table below, indicating
where all non-surgical procedures will be performed. Be sure to include
the sites of procedures such as radiography, fluoroscopy, computed axial
tomography (CT), or magnetic resonance imaging (MRI) that may be
performed outside the animal facility.

  --------------------- ---------------- ---------------------------------
  Non-surgical          Building and     Method of discreet transport, if
  Procedure             Room Number      required through
                                         [non-research]{.underline} areas
                                         (enter N/A if not applicable)\*

  **     **             **     **        **     **

  **     **             **     **        **     **

  **     **             **     **        **     **
  --------------------- ---------------- ---------------------------------

> \*Describe how animals will be transported to and from these sites.
> Transportation must be in accordance with the *Guide*, USDA
> regulations, and PHS policy in climate-controlled vehicles and
> sanitizable transport cages when appropriate. Transport through
> non-research areas must be discreet. Once completed, proceed to item
> S.

S. **Body Fluid, Tissue, and Device Collection.**

> 1\. Will any body fluids, tissues, or devices be collected from
> animals [AFTER]{.underline} euthanasia?
>
> No. Proceed to item S.2.
>
> Yes. List the fluids, tissues, and/or devices here; then proceed to
> item S.2. **     **
>
> 2\. Will any body fluids, tissues, or implanted devices or materials
> be collected from animals [BEFORE]{.underline} euthanasia?
>
> No. Proceed to item T.
>
> Yes. Proceed to item S.3.
>
> 3\. Is collection in live animals limited to blood collection
> associated with antibody production?
>
> No. Complete and attach Appendix 4, "Antemortem Specimen Collection."
> Then proceed to item T. If the body fluid, tissues, or devices are
> collected as a surgical procedure, please be sure to also describe
> these collections as part of the surgical protocol in the Appendix 5,
> "Surgery."
>
> Yes. Because blood collection associated with antibody collection is
> already described in Appendix 2, "Antibody Production", DO NOT
> complete Appendix 4, "Antemortem Specimen Collection." Proceed to item
> T.

T. **Surgery.** Will survival or non-survival surgery be performed?

> No. Proceed to item U.
>
> Yes. Complete and attach Appendix 5, "Surgery;" then proceed to item
> U.

U. **Endpoint Criteria.** What specific endpoint criteria will be used
for determining when sick animals, [both on and off study]{.underline},
will be euthanatized or otherwise removed from a study? Examples of
appropriate criteria that should be considered include a weight loss
limit as a percentage of initial or expected body weight, allowable
durations of anorexia, allowable tumor size or total tumor burden
expressed as a percentage of body weight, the presence of health
problems refractory to medical intervention, and severe psychological
disturbances. Other criteria appropriate for the species under
consideration should also be considered. When complete, proceed to item
V. **     **

V. **Euthanasia**. Will animals be euthanatized as part of the planned
studies?

> No. Describe the final disposition of the animals here, then proceed
> to item V.4: **     **
>
> Yes. Complete items V.1. - V.4. below; then proceed to item W.

1.  Describe the exact method of euthanasia for each animal used.
    Include the agents used, dose (as applicable), and route of
    administration. **     **

2.  Justify any method that is not considered "acceptable" by the latest
    report of the AVMA Panel on Euthanasia. [(More info- item
    V.2)](http://www.vmuinfo.org/acorp/draftacorpref.html#acorpu2) If
    you are unsure how to answer, contact your veterinarian or IACUC for
    guidance. If all methods are considered acceptable by the Panel,
    enter "All methods meet AVMA Panel recommendations" below: **     **

3.  List the personnel who will perform euthanasia and indicate their
    training and experience with the method of euthanasia and the
    species involved. If personnel are not yet trained, indicate so and
    explain how they will be trained before performing euthanasia
    themselves. **     **

4.  Should the animal care staff find an animal dead, how should the
    carcass be handled (e.g. refrigerated or frozen), and should a
    member of your staff be contacted immediately? **     **

W. **Special Procedures.** Are any experimental procedures or special
husbandry procedures planned that are NOT described in the local
standard operating procedures (SOP) manual or elsewhere in this ACORP?
Special procedures can include special restraint practices (including
non-human primate chairing), special animal health monitoring, special
diets, caging, environmental control, exercise, environmental
enrichment, means of identification, use of noxious stimuli, forced
exercise, or behavioral manipulation.

> Yes. Complete and attach Appendix 6, "Special Husbandry and
> Procedures;" then proceed to item X.
>
> No. Proceed to item X.

# Mandatory Considerations

X. **Consideration of Alternatives and the Prevention of Unnecessary
Duplication.** Complete items X.1 through X.5 below; then proceed to
item Y. Keep copies of computer database search results in your files to
demonstrate your compliance with the law if regulatory authorities or
the IACUC should choose to audit your project.

> 1\. Investigators must consider less painful or less stressful
> alternatives to procedures, and provide assurance that proposed
> research does not unnecessarily duplicate previous work. You should
> perform one or more database searches to meet these mandates unless
> compelling justifications can be made without doing so. Complete the
> table below for each database search you conduct to answer items X.2
> through X.5 below. You must provide complete information in the first
> four columns of the table to comply with USDA Policy #12.

  ---------- ----------- --------- ---------- ------------- --------------- ------------- --------------
  Name of    Date        Period    Key words  Indicate                                    
  the        performed   (years)   and/or     below for                                   
  database               covered   search     which mandate                               
  (s)                    by each   strategy   each search                                 
                         search    used       was conducted                               
                                              by placing an                               
                                              "X" in the                                  
                                              proper column                               

                                              Alternative   Alternative use Alternative   Lack of
                                              computer      of              use of less   un-necessary
                                              models or *in less-sentient   stressful     duplication
                                              vitro*        species (item   model or      (item W.5)
                                              techniques    W.3)            methods, or   
                                              (item W.2)                    fewer animals 
                                                                            (item W.4)    

                                                                                          

                                                                                          

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

> 2\. Could any of the animal procedures described in this ACORP be
> replaced by computer models or *in vitro* techniques? Indicate below
> if such replacement is or is not possible, and provide a narrative on
> how you came to your conclusion. **     **

3.  Could a smaller, less sentient mammalian species or a non-mammalian
    species (e.g. poultry, fish, invertebrates) substitute for the
    mammals in any of the experiments planned? Indicate below if such
    substitution is or is not possible and provide a narrative on how
    you came to your conclusion. **     **

4.  Could a different animal model or different animal procedure that
    involves 1) less distress, pain, or suffering, or 2) fewer animals
    substitute for any proposed animal model or animal procedure
    planned? Indicate below if such replacement is or is not possible,
    and provide a narrative on how you came to your conclusion.
    **     **

5.  Does the proposed research [unnecessarily]{.underline} duplicate
    previous work? Indicate below if the proposed work unnecessarily
    duplicates previous work and provide a narrative on how you came to
    your conclusion. **     **

Y. **Other Regulatory Considerations**. Complete items Y.1, Y.2, and Y.3
below; then proceed to item Z.

> 1\. **Controlled drugs**.
>
> a\. Will all drugs used in animals and classified as controlled
> substances by the DEA or your state drug enforcement authority be
> stored in a double-locked cabinet, and be accessible only to
> authorized personnel in accordance with DEA regulations?
>
> Not applicable- no controlled drugs will be used. Proceed to item Y.2.
>
> No. Please explain here, then go to item Y.1.b.: **     **
>
> Yes. Complete item Y.1.b.

b.  List the controlled substances that will be used in vivo for this
    project, and include the building and room number where they will be
    stored. **     **

2\. Will any human patient procedural areas be used for these animal
studies?

> No. Proceed to item Y.3.
>
> Yes. Complete and attach Appendix 7, "Request to Use Patient
> Procedural Area;" then proceed to item Y.3.

3\. Will an explosive anesthetic or other explosive agent be used in any
portion of these animal studies? [(More info- item
Y.3)](http://www.vmuinfo.org/acorp/draftacorpref.html#acorpx3)

> No. Proceed to item Z.
>
> Yes. Complete and attach Appendix 8, "Request to Use Explosive Agent;"
> then proceed to item Z.

Z. Please indicate which of the following Appendices are completed and
attached. [Do not attach blank appendices which are not applicable to
this ACORP]{.underline}.

> Appendix 1, "Use of Non-VA Animal Facility" (reference item N)
>
> Appendix 2, "Antibody Production" (reference item P)
>
> Appendix 3, "Test Substances" (reference item Q)
>
> Appendix 4, "Antemortem Specimen Collection" (reference item S)
>
> Appendix 5, "Surgery" (reference item T)
>
> Appendix 6, "Special Husbandry and Procedures" (reference item W)
>
> Appendix 7, "Request to Use Patient Care Procedural Areas for Animal
> Studies" (reference item Y)
>
> Appendix 8, "Request to Use Explosive Agent" (reference item Y)
>
> Appendix 9, "Rodent Breeding Appendix" (reference item O)

AA. **Certifications.** Signatures of the Principal Investigator(s),
IACUC Chair, veterinarian, and R&D Committee Chair are mandatory; others
may NOT sign for them. Copies (including FAX transmissions) of original
signatures are fine, but stamps and digital graphics file reproductions
are [not]{.underline} acceptable. [Note: Signatures must be less than
one year old if this form is part of an application submission to VA
Headquarters.]{.underline}

> 1\. **Certification by Principal Investigator(s).**
>
> To the best of my knowledge, I certify that the information provided
> in this Animal Component of Research Protocol (ACORP) is complete and
> accurate. I understand that IACUC approval is valid for one year only,
> that approval must be renewed annually, that every third year the
> IACUC must perform a new review of my protocol, and that I might be
> required to complete a newer version of the ACORP and provide
> additional information at the time of the triennial review. [I also
> understand that IACUC approval must be obtained before I:]{.underline}

• Use additional animal species, increase the number of animals used, or
increase the number of procedures performed on individual animals;

• Change procedures in any way that might increase the pain/distress
category in which the animals are placed, or might otherwise be
considered a significant departure from the written protocol;

• Perform additional procedures not described in this ACORP;

• Allow other investigators to use these animals on other protocols, or
use these animals on another of my IACUC-approved protocols.

> I further certify that

-   [No personnel will perform any animal procedures until they have
    been approved by the IACUC]{.underline}. When new or additional
    personnel become involved in these studies, I will submit their
    qualifications, training, and experience to the IACUC and seek IACUC
    approval before they are involved in animal studies;

-   I will ensure that all personnel are enrolled in the institutional
    Occupational Health and Safety Program prior to their contact with
    animals;

-   I will provide my after-hours telephone numbers to the VMU in case
    of emergency.

  ------------------------- ------------------------------------ ---------
  Name of Principal         Signature                            Date
  Investigator(s)                                                

  **     **                                                      

  **     **                                                      

  **     **                                                      
  ------------------------- ------------------------------------ ---------

6.  **Minority Opinions (For IACUC Use).** IACUC members
    [must]{.underline} be given the opportunity to submit minority
    opinions on this form. Enter any written minority opinions here (or
    attach separate pages labeled "IACUC Minority Opinion"). If there
    are no minority opinions, leave this space blank. **     **

> 3\. **Approval Signatures.**
>
> a\. To the best of their abilities, the undersigned have evaluated the
> care and use of the animals described in this ACORP in accordance with
> the provisions of the USDA Animal Welfare Act Regulations and
> Standards, PHS Policy, the *Guide for the Care and Use of Laboratory
> Animals* and VA Policy, and find the procedures in this ACORP to be
> appropriate.

  ------------------------- ------------------------------------ ---------
  Name of Attending         Signature                            Date
  Veterinarian (VMO or VMC)                                      

  **William F. Stack, DVM**                                      

  Name of IACUC Chair       Signature                            Date

  **Shaker Mousa, Ph.D.**                                        
  ------------------------- ------------------------------------ ---------

> b\. The VA Research and Development Committee concurs with approval of
> the procedures described in this ACORP, and has approved the overall
> scientific merit of this project.

  ------------------------- ------------------------------------ ---------
  Name of R&D Committee     Signature                            Date
  Chair                                                          

  **Kenneth Phelps, M.D.**                                       
  ------------------------- ------------------------------------ ---------