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

Use of Version 2 or 2a is OK until 1/1/05, then Version 3 must be used

Check all that apply:

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

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

**Version 3**

**Note:** Use a separate form for each species. DO NOT include
individual appendices if they are not relevant to the protocol being
described. To check boxes, right click, choose properties, then click to
check the box. [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]{.underline}:

University Departmental Funds. [Identify]{.underline} University and
Department:

Private Company. [Identify]{.underline}:

Other. [Identify]{.underline}:

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

Yes. Proceed to item 7.

No. Answer A.6.a-d. 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 ([see item d.
> below]{.underline}).
>
> Other. [Please specify]{.underline}:
>
> b\. Previous ACORP title:
>
> c\. Previous IACUC approval number (VA and affiliate, if applicable):
>
> d\. If this is a three-year renewal, provide a progress report
> describing work accomplished during the last approval period. Include
> the number of animals used, the objectives that were met and how the
> work proposed in this renewal extends the previous studies. If not
> applicable, go to item 7.

7\. Do you plan on performing the animal procedures described in this
form even if you do [not]{.underline} receive intramural VA or
extramural 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]{.underline}:

## Proposal Overview

B. **Lay Description.** 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. **Experimental Design.**

> 1\. Using non-technical (lay) language that a [senior high school
> student]{.underline} 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, 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.]{.underline}

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]{.underline}, then proceed to item H:

No. Proceed to item H.

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

  --------------- ------------ -------------- -------------- --------------
  Strain, Stock,  Gender       Age/Size       Source         Health
  Mutant, or                                  (Vendor)       Status\*
  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                    anesthetic
                          and how long                     used, plus
                          animals will be                  dose, route,
                          monitored                        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. If
the species is covered by UDSA regulations, 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.]{.underline} If animals will undergo category D procedures as
well, describe them in item J.1. above.

K. **Justification for number of animals requested and group sizes.**
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]{.underline}. [A power analysis is
strongly encouraged to justify group sizes when
appropriate]{.underline}. Once completed, proceed to item L.

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 [and their
institutional affiliation]{.underline}:

> 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
item 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]{.underline}:
>
> 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.

3\. Please provide a justification for housing social animals singly;
then proceed to item 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 genetically
> engineered or modified (e.g. transgenic/knockout/knockin) animals.
> Proceed to item M.7.
>
> This ACORP addresses the use of dogs. Answer item M.6.a. below, and
> M.6.c if applicable.
>
> This ACORP addresses the use of primates. Answer item M.6.b. below,
> and item M.6.c. if applicable.
>
> This ACORP addresses the use of genetically engineered or modified
> animals. 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]{.underline}; 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 for excluding the
> primates]{.underline}; then proceed to item M.7.:

c\. Do the genetically engineered or modified animals exhibit any
characteristic clinical signs or abnormal behavior related to their
genotype?

> No. Proceed to item M.7.
>
> Yes. [Describe here]{.underline}, 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 implantation and wound management measures will be
> taken to minimize the chances of chronic infections around the
> device(s) where they penetrate the skin (then proceed to item N):

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 a Non-VA Facility to
> House Animals Purchased with VA or VA Research And Education
> Corporation Funds", then go to item N.2.
>
> 2\. Give the location(s), inside or outside of the animal facility,
> where animals will be housed permanently or temporarily, then proceed
> to item O:

O. **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 P.
>
> Yes. Complete and attach Appendix 2, "Antibody Production;" then
> proceed to item P.

P. **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: 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 U, Euthanasia.)

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

Q. **Location of procedures.** Complete the table below, indicating
where all non-surgical procedures and manipulations will be performed.
[The IACUC must be aware of all procedures performed outside of the
animal facility]{.underline}. To help the IACUC track the sites of
animal use outside the animal facility, give the location of any
laboratory or other areas outside of the animal facility in which
animals will be manipulated in any way. 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 Procedure  Building and    Method of discreet transport,
                          Room Number     if 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. [Such transport must be
> discreet such that hospital staff and patients are not aware of the
> transport, and are not exposed to allergens and/or body fluids from
> the transported animal(s)]{.underline}. Once completed, proceed to
> item R.

R. **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 R.2.
>
> Yes. [List the fluids, tissues, and/or devices here]{.underline}; then
> proceed to item R.2.:
>
> 2\. Will any body fluids, tissues, or implanted devices or materials
> be collected from animals [BEFORE]{.underline} euthanasia?
>
> No. Proceed to item S.
>
> Yes. Proceed to item R.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 S. 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 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
> S.

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

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

T. **Endpoint Criteria.** What specific endpoint criteria will be used
for determining when sick animals, both on and off study, 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 U.:

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

> No. [Describe the final disposition of the animals here]{.underline},
> then proceed to item U.4:
>
> Yes. Complete items U.1. - U.4. below; then proceed to item V.

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

2\. Are all euthanasia methods acceptable according to the latest report
of the AVMA Panel on Euthanasia? ([if you are unsure how to answer,
contact your veterinarian or IACUC for guidance]{.underline})

> Yes. Proceed to item U.3.
>
> No. [Justify]{.underline} any method that is not considered
> "acceptable" by the latest report of the AVMA Panel on Euthanasia,
> then proceed to item U.3.:

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\. If 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?

V. **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 W.
>
> No. Proceed to item W.

W. **Consideration of Alternatives and the Prevention of Unnecessary
Duplication.** Complete items W.1 through W.5 below; then proceed to
item X. 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 W.2
> through W.5 below. [You must provide complete information in the first
> four columns of the table to comply with USDA Policy #12]{.underline}.

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

                                                      Computer      Use of          Use of less Lack of
                                                      models or *in less-sentient   stressful   unnecessary
                                                      vitro*        species (item   model or    duplication
                                                      techniques    W.3)            methods, or (item W.5)
                                                      (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]{.underline}:
>
> 3\. Could a smaller, less sentient mammalian species or a
> non-mammalian species (e.g. 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]{.underline}:
>
> 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]{.underline}:
>
> 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]{.underline}:

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

> 1\. **Controlled drugs**.
>
> a\. Will all drugs used in animals and classified as controlled
> substances by the DEA be stored in a double-locked cabinet, and be
> accessible only to authorized personnel in accordance with VA policy?
>
> Not applicable- no controlled drugs will be used. Proceed to item X.2.
>
> No. [Please explain here]{.underline}, then go to item X.1.b.:
>
> Yes. Complete item X.1.b.
>
> b\. List the controlled substances that will be used in animals for
> this project here, and include the building and room number where they
> will be stored, then go to item X.1.c.:
>
> c\. To comply with VA pharmacy policies, all controlled substances
> used on VA property must be ordered through and received by the local
> VA pharmacy prior to issue for research use. Will the use of all
> controlled substances comply with these VA pharmacy policies?
>
> No. [Please explain]{.underline} (then proceed to item X.2):
>
> Yes. Proceed to item X.2.

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

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

3\. Will an explosive anesthetic or other explosive agent be used in any
portion of these animal studies?

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

Y. **Appendices.** Please indicate which of the following Appendices are
completed and attached. [Do not attach blank appendices which are not
applicable to this ACORP]{.underline}. Check with your IACUC to see if
an optional Appendix 9, "Additional Local Information", is required.

> Appendix 1, "Use of a Non-VA Facility to House Animals Purchased with
> VA or VA Research and Education Corporation Funds" (ref item N)
>
> Appendix 2, "Antibody Production" (ref item O)
>
> Appendix 3, "Test Substances" (ref item P)
>
> Appendix 4, "Antemortem Specimen Collection" (ref item R)
>
> Appendix 5, "Surgery" (ref item S)
>
> Appendix 6, "Special Husbandry and Procedures" (ref item V)
>
> Appendix 7, "Request to Use Patient Care Procedural Areas for Animal
> Studies" (ref item X)
>
> Appendix 8, "Request to Use Explosive Agent in the Animal Facility or
> in Animals" (ref item X)
>
> Appendix 9, "Additional Local Information"

Z. **Certifications.** [**Important**: If this ACORP will be submitted
to VA Central Office for Just-In-Time approval prior to receiving VA
funding, the signatures of the Principal Investigator(s), IACUC Chair
and veterinarian must appear below in items Z.1 and Z.3.]{.underline}
*The requirement for an R&D Committee Chair signature and the
requirement that signatures be less then a year old have been dropped*.

> 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 an institutional
    Occupational Health and Safety Program prior to their contact with
    animals, or have declined in writing to participate, if allowed by
    local policy]{.underline};

-   I will provide my [after-hours telephone numbers]{.underline} to the
    animal care staff in case of emergency.

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

                                                                 

                                                                 

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

> 2\. **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.** To the best of their abilities, the
> undersigned verify that the IACUC has 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 use of animals described in this ACORP to be appropriate.

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

                                                                 

  Name of IACUC Chair         Signature                          Date

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