The George Washington UniversityInstitutional Animal Care and Use Committee

APPLICATION TO USE VERTEBRATE ANIMALS IN RESEARCH, TESTING OR INSTRUCTIONFebruary 2013

IMPORTANT -- ALLOW 4-6 WEEKS FOR APPROVALINCOMPLETE FORMS MAY CAUSE REVIEW TO GO INTO THE NEXT REVIEW

CYCLE DELAYING APPROVAL AN ADDITIONAL 4-6 WEEKS

THIS FORM MUST BE SUBMITTED AS A WORD FILE VIA EMAIL TO: iacuc@gwu.edu

Approval is renewable annually for up to an additional two years. Continuation of the approved animal usage beyond three years requires completion of a new application form and complete

IACUC review.

See Instructions for completing the A Form at http://research.gwu.edu/iacuc-forms

Sections will expand to accommodate text where needed.

PROJECT / COURSE TITLE (this has to match the grant title):

For Committee Use Only

Date Received:IACUC No.:Parent No.FCR DateFCR Approval DateSciMerit DateDesgR DateDesgR AutoApproval DateIBC DateRSC Date

Approval Date

Expiration Date

GENERAL INFORMATIONThis section must be filled out by all PIs

The IACUC A form is now split into sections. Please check the following boxes for all sections you are including with this submission

Surgical Procedures (A) Antibody/Ascites Production (D)

Breeding Colony (B) Physical Restraint (>) 15 min. (E)

Bio-Safety Information (C) Food/Fluid Restriction (F)

PRINCIPAL INVESTIGATOR(As designated by Contracts & Grants)

LAST NAME: FIRST NAME: MIDDLE INITIAL: GWID NUMBER:

ACADEMIC RANK / TITLE:

DEPARTMENT: CAMPUS TELEPHONE NUMBER:

CAMPUS ADDRESS: FAX NUMBER:

e-mail address: EMERGENCY NUMBER:

CO-PRINCIPAL INVESTIGATOR(Regular / Fixed-term / Visiting / Adjunct / Clinical Faculty, Research Associate, Specialists, Postdoctoral Fellows):

LAST NAME: FIRST NAME: MIDDLE INITIAL: GWID NUMBER:

ACADEMIC RANK / TITLE: :

DEPARTMENT: CAMPUS TELEPHONE NUMBER:

CAMPUS ADDRESS: FAX NUMBER:

e-mail address EMERGENCY NUMBER:

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DEPARTMENTAL SIGNATURES

PRINCIPAL INVESTIGATOR'S ASSURANCE

I agree to abide by all federal and state regulations, The George Washington University (GWU) and Institutional Animal Care and Use Committee (IACUC) policies concerning the use of animals.

All use of vertebrate animals shall be covered by an IACUC Animal Use Form that has been reviewed and approved by the GWU IACUC and that IACUC approval shall be obtained prior to ordering animals and/or performing any animal procedures described in this form.

The personnel performing animal manipulation, experimental techniques, surgery, etc. are adequately trained and have completed all required training prior to performing those procedures.

I will immediately notify the IACUC regarding any unexpected study results that negatively impacts the animals. Any unanticipated pain or distress, morbidity or mortality will be reported to the Attending Veterinarian and the IACUC.

Any proposed changes to this protocol need to be reported by sending an amendment/modification form to the IACUC outlining the changes. IACUC approval must be obtained prior to performing the revised animal procedures described therein.

I will maintain appropriate animal records (e.g., census, health, veterinary care, euthanasia, surgery, diagnostic, anesthesia, etc.).

I will do everything within my power to safeguard the health and well-being of each animal under this protocol.

I accept responsibility that all personnel working on this project are aware of, and will follow the approved procedures outlined in this form.

As required by federal regulations I assure that the activities described do not unnecessarily duplicate previous experiments.

I understand that approval of projects is for a maximum of three years from the date of approval, provided an annual renewal is completed, signed and returned to the IACUC office. I understand that the IACUC can call for a complete review of the project as needed.

By submitting this form, I agree to follow up activities to include post approval monitoring by the IACUC or agent of the IACUC at least annually.

I understand that the information contained herein does not materially conflict with and/or deviate from information PRINCIPAL INVESTIGATOR: DATE:

CO-PRINCIPAL INVESTIGATOR: DATE:

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PROJECT/COURSE TITLE AND FUNDING AGENCY(if you have more than one project to put on this form, please copy & paste this page as many times as needed)

PROJECT / COURSE TITLE (this has to match the grant title):

FUNDED BY:

FOR EXTERNAL FUNDING, PLEASE FILL IN THE BOXES BELOWFUNDING AGENCY GRANT NUMBER: GWU CONTRACT & GRANT APP NUMBER: ACCOUNT NUMBER: SUB-ACCOUNT NUMBER:

FOR INTERNAL FUNDING PLEASE NOTE THAT THE IACUC WILL FORWARD THIS PROTOCOL TO AN INDIVIDUAL TO REVIEW ITS SCIENTIFIC MERIT. BE ADVISED THAT INDIVIDUALS WITH A CONFLICT OF INTEREST CANNOT CONDUCT THIS REVIEW.

CLASSIFICATION OF THIS RESEARCH PROJECT

Biomedical Teaching/Instruction Wildlife/Field

Testing Other:

FOR THE ABOVE PROJECT THE FOLLOWING ANIMALS WILL BE USED

IF THIS IS A THREE YEAR RENEWAL, PLEASE FILL IN THE FOLLOWING FOR ANIMALS YOU WILL BE TRANSFERRING WHEN THE CURRENT PROTOCOL BECOMES INACTIVE

All animals remaining on the expiring protocol must be officially transferred to the new protocol. If the remaining animals on the old protocol are not needed for the new protocol, consult with the IACUC Research Liaison about options for using the remaining animals.

THE ANIMALS REQUIRED FOR THIS RESEARCHFor each species, estimate the total number of animals that will be used over the next 3 year period (or for the life of the project if less than 3 years), in the boxes under each appropriate Humane Use Category B, C, D, or E (see BELOW). For field studies estimate the number of animals per species you expect to observe or collect. For transgenic animals, provide the complete nomenclature. Add additional rows to the table as necessary. WHEN FILING AN AMENDMENT TO ADD ADDITIONAL ANIMALS, PLEASE DO NOT ADD TO THE EXISTING NUMBER – USE A NEW LINE.

SPECIES COMMON NAME

(PLEASE INCLUDE THE STRAIN, if applicable)

List total # of animals to be usedIn each of the appropriate categories

TOTALNUMBER OF

NEW ANIMALS

TOTALNUMBER OF

TRANSFERREDANIMALS

(Protocol No.)

TOTAL NUNBER OF

ANIMALS

B C D E

Explanation of USDA Reporting Codes:USDA Category B: Animals that will be bred or purchased for breeding, but not used for experiments. This includes breeders, offspring that cannot be used because of improper genotype or gender and any other animals that will not participate in the research studies.USDA Category C: Animals used in research, experiments, or tests which involve no pain or distress or only momentary or slight pain or distress that WOULD NOT REQUIRE anesthetic, analgesic or tranquilizing agents (examples: s.c., i.m., i.p. percutaneous i.v. injection, a brief period of restraint, tissue harvesting after euthanasia has been performed).USDA Category D: Animals used in research, experiments, or tests where appropriate anesthetic, analgesic, or tranquilizing agents are used to avoid pain or distress (examples: major and minor surgery, tissue or organ collection prior to euthanasia, retro-orbital blood collection, prolonged restraint accompanied by tranquilizers or sedativesUSDA Category E: Animals used in research, experiments, or tests involving pain or distress in which the use of appropriate anesthetic, analgesic or tranquilizing agents would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests (examples: studies which allow endpoints that are painful or stressful, addictive drug withdrawals without treatment, pain research, noxious stimulation). IF YOU LIST ANIMALS IN THIS CATEGORY YOU MUST PROVIDE A DETAILED JUSTIFICATION YOU MUST PROVIDE THE IACUC WITH ENDPOINTS THAT WILL STOP THE PAIN/DISCOMFORT AS SOON AS POSSIBLE. QUESTIONS 10-11).

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EMERGENCY CONTACT PERSONS

In the event of an animal welfare issue, please list GWU personnel other than those previously listed who have detailed knowledge of the use of animals for this project and who can authorize treatment and/or euthanasia for on campus projects if the principal investigator and co-PI are unavailable.

Name

Campus Phone

Cell/Emergency Phone

Email address

Name

Campus Phone

Cell/Emergency Phone

Email address

Name

Campus Phone

Cell/Emergency Phone

Email address

Name

Campus Phone

Cell/Emergency Phone

Email address

Name

Campus Phone

Cell/Emergency Phone

Email address

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PURPOSE AND POTENTIAL VALUE OF STUDY

1. Using terminology that a non-scientist could understand, explain what you are going to do and how these procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society. A few well-written sentences will suffice. Abbreviations and acronyms should be spelled out and explained the first time they are used. A section from your grant application, using highly technical terms, is not acceptable. This information may be used for press releases and/or responses to Freedom of Information Act (FOIA) requests.

RATIONALE FOR ANIMAL USE

2. What alternatives to the use of live animals have you considered? If alternatives are unacceptable, please explainWhy. If specific alternatives to live animal use do not exist, this should be stated.

3. Justify the appropriateness of the species and, if appropriate, the strains to be used.

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PROCEDURES(shaded areas are for office use only)

4. Please check all boxes below that best describe what will be performed on the animals to be used in this application, and explain in question 5.

Amputation (including toe/tail clipping)

Antibody Production (complete Section D)

Behavioral modification

Biological Material / Recombinant DNA / Controlled Substances (complete Section C)

Breeding (complete Section B)

Food/water restriction (excluding surgical) (complete Section F)

Hazardous Chemicals (Biological, Chemical, Radioactive) (complete Section C)

Induced experimental infectious disease

Induced experimental non-infectious disease

Injections or inoculations

Injury/trauma

Nutritional studies

Obesity (experimental)

Organ/system failure/dysfunction experimentally induced

Pain Research

Paralysis experimentally induced

Pharmacological studies

Restraint of a conscious animal longer than 15 minutes (complete Section E)

Sample collection (blood, urine, tissue, etc)

Surgical procedure, non survival (complete Section A)

Surgical procedure, survival (complete Section A)

Surgical procedure, multiple major survival (complete Section A)

Teaching

Tumor growth experimentally induced / implantation

Other

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PROJECT DESCRIPTIONDO NOT CUT AND PASTE FROM A GRANT PROPOSAL. INCLUDE ONLY THE INFORMATION THAT EXPLAINS

WHAT IS BEING DONE TO THE ANIMALS. FOR BREEDING COLONIES, PLEASE FILL OUT SECTION B.

5. Please list each planned study aim and explain the experimental design for each. For each study aim please clearly indicate the experimental groups and the numbers of animals to be used for each. This description should also provide sufficient procedural detail and clearly indicate what happens to animals from acquisition to final disposition. Denote the approximate time line of procedures. Provide a brief overview of work done on tissue post euthanasia. In depth descriptions of surgical procedures should be explained in Section A. Your target audience is an external inspector and/or a faculty member from a discipline that may be unrelated to yours.If you are referencing any Standard Operating Procedures, be sure to include it with this protocol.

Specific Aims Experimental Groups

No. of Animals

Procedures/Manipulations

Ageat start of Exp.

TimelineAdditional

Info

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SCIENTIFIC JUSTIFICATION FOR THE NUMBER OF ANIMALS TO BE USED

6. Please provide scientific justification for the number of animals to be used. The listing of the specific aims with the experimental groups and animal numbers should have been provided in question 5.

a. Teaching protocols: (e.g., animal numbers are typically determined by a specified student-to-animal ratio, which must be explained in the justification narrative. Animal numbers should be minimized to the fullest extent possible without compromising the quality of the hands-on teaching experience for students or impact animal welfare)

b. Tissue harvest required for i n-vitro work (including antibody production) : (e.g., animal numbers are typically determined by the amount of tissue/cells required and the number of individual animals needed to provide the appropriate amount of tissue/cells or antibodies, etc.)

c Exploratory or pilot studies (use of live animals to demonstrate success or failure of a desired goal, such as the production of transgenic mice, proof of concept, or survey of a population): (e.g., animal numbers are typically justified based on the probability of the experimental procedure, and the PI’s experience and professional judgment)

d. Hypothesis driven research: (e.g., if possible, animal numbers should be determined by statistical power analysis. Alternatives, appropriate numbers of animals may be determined based on comparable studies for which the desired effect sizes were shown to be statistically significant)

e. Field studies: (e.g., especially those with the intent of characterizing abundance, the number of animals are usually based on past experience)

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ANIMAL CAREPlease note that animals must be observed daily and health records must be readily available

7. List and describe adverse consequences that the animals could experience as a direct result of the procedures described above. Examples of adverse consequences might include unkempt coat, ascites, difficulty rising, inflammation, self-trauma, weight loss, loss of appetite, paralysis, death, etc. These are consequences that could be reasonably predicted based on experience or knowledge of the literature.

8. Please list who on the research team will conduct the necessary observations after experimental procedures. Be sure to detail the training of these individuals in their personnel form (page 14).

Provide the monitoring sheet for individual animals that will be used to note the health and welfare of the animals post procedurally. The sheet should indicate what specific signs will be monitored and what will be considered to be evidence of pain and discomfort. The individual doing the monitoring must be indicated on the sheet. An example of such a monitoring sheet is available at http://research.gwu.edu/iacuc-forms - Rodent Health Monitoring. Please also indicate how frequently the animals will be monitored and rational for that frequency.

9. What care will be provided for animals suffering from these adverse consequences?

10. Severe Illness: Describe the clinical signs that dictate when an animal will be euthanized.

11. Death as an End Point: Please provide scientific justification why it is not possible to euthanize the animals at an earlier point in the study (“death as an endpoint” refers to acute toxicity testing, assessment of virulence of pathogens, neutralization tests for toxins, and other studies in which animals are not euthanized, but die as a direct result of the experimental manipulation.). If the animal can euthanize at an earlier point, describe the clinical signs which will dictate when an animal will be euthanized.

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NON-SURGICAL DRUGS AND/OR AGENTS

12. List all non-surgical drugs and/or agents used in this project (drugs and/or agents used in Surgical procedures should be included in Section A). See (http://research.gwu.edu/iacuc-forms – Rodent Anesthesia Techniques) for a listing of common anesthetic agents and dosages.

drug name(s)(generic only) dosages route of

administrationfrequency of

dosagesduration of treatment(# of days or hours)

13. Paralytics (Please list below any paralytic use)

drug name(s)(generic only) dosages route of

administrationfrequency of

dosagesduration of treatment(# of days or hours)

Scientifically justify why Paralytic need to used:

How will the animal be monitored during the paralytic period and what is the training of the person doing the monitoring?

What precautions will be taken to minimize any pain and/or distress during the paralytic period?

SAMPLE COLLECTION

14. Complete the table below for any specimen collection (tissue or body fluid) from LIVE animals.

Types ofSamples Collected

Site ofSample Collection

Method ofSample Collection

Volumeof Sample

Number ofSamples

Frequencyof Collection

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FINAL DISPOSITION SECTION

15. Check all options that could happen:

Euthanasia

Transferred to another PI with an approved IACUC Form

Adoption (a record of adoption must be kept in the files)

Other (please explain)

16. Please indicate the method of euthanasia. If using drugs, be sure to indicate the dosage and method of administration.

17. If the method of euthanasia used is not recommended by the current AVMA Guidelines on Euthanasia (https://www.avma.org/KB/Policies/Documents/euthanasia.pdf) please provide scientific justification.

18. What is the secondary method used to ensure death (e.g., removal of heart, induction of bilateral pneumothorax, observation of cessation of heart beat and respiration accompanied by fixed and dilated pupils and loss of corneal reflex, etc.)?

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DATABASE SEARCHComplete this section (questions 19 and 20) only for animals listed in Category D or E.

This requirement applies to all animals used in biomedical research, testing, and/or education activities which include the potential for pain and/or distress.

19. The GWU IACUC policy states that database searches remain the most effective and efficient method for demonstrating compliance with the requirement to consider alternatives or refinements to painful/distressful procedures (e.g.: modification of any procedures that operate from the time a laboratory animal is born until its death that minimize the pain and distress experienced by the animal and enhance its well-being) . When a database search is the primary means of meeting this requirement, the narrative about the search must include the following: The names of the databases used (there must be a minimum of two searched), the date on which the search was performed, what years of the databases were covered, and the keywords or search strategy used (the keywords/search strategy must reflect one that looks for ways to minimize pain and distress – this can include a search for alternative or refined procedures, modified anesthetic or pain management protocols, or other means to reduce pain and distress). Information on how to conduct alternative searches can be found at www.lib.ucdavis.edu/dept/animalalternatives/ and at http :// altweb.jhsph.edu / resources / searchalt / index.html .Further information on the concept of the Three R’s in animal research (Reduction, Refinement & Replacement) can be found at: http://awic.nal.usda.gov/alternatives.

Database Name Date Search was performed

Years Covered Keywords/Search Strategy

20. Summarize your findings with respect to alternatives and refinements to potentially painful procedures. If alternatives or refinements/modifications to painful/distressful procedures were not found, please state that. If they were found, please explain which ones you will be using or why they cannot be used. (Please do not list your search results).

ANIMAL HOUSING

21. Housing location: Please check the appropriate box below

ARF (Ross Hall) Samson Hall

Lisner Hall Bldg GG

Bell Hall

Other (please specify):

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22 Will your animals the maintained outside approved housing areas for more than 12 hours?

Yes: this must be justified and approved by the IACUC No

Building and room where the animals will be maintained:

Justification:

EXCEPTIONS TO THE GUIDELINES

23. If the pertinent guidelines are not being followed, state what the exception is and the reason for the exception. Check all boxes that apply.

Guide for the Care and Use of Laboratory Animals: http://www.nap.edu/catalog.php?record_id=12910#toc Guide for the Care and Use of Agricultural Animals in Research and Teaching:

http://www.fass.org/docs/agguide3rd/Ag_Guide_3rd_ed.pdf Animal Welfare Act Regulations: http://awic.nal.usda.gov/government-and-professional-resources/federal-

laws/animal-welfare-act Or the applicable species field guide: http://awic.nal.usda.gov/research-animals/wildlife-field-studies

Temperature/ Humidity Lighting Intensity Photo period Air Quality / Ventilation

Space Requirements Sanitation / Waste Disposal Pest Control

Feed Noise Water

Social Environment Activity Bedding Other

Describe and justify exception:

ENRICHMENT

24 Explain what enrichment being providing. Information on types of enrichment recommended for a particular species can be found at the IACUC web site:http://awic.nal.usda.gov/research-animals/environmental-enrichment-and-exercise

Nestlets/nesting material Toys

Group housing Food treats:

Exercise runs Other:

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USE OF CELL LINES

25. If you will be using rodent cell lines in your research, has the cell line been tested for latent infection?

Yes. Please attach a copy of the results.

No. The cell lines cannot be used until they have been screened and approved for use. Contact ARF for information

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PERSONNEL FORMPersonnel Forms MUST be completed for each individual involved in the care and use of animals under the Animal Use Form. By filling out this form you are verifying that you have read the protocol under which you will be working prior to working with animals and that you will perform only those procedures listed on the approved protocol with the species listed on the protocol. In addition that you have a responsibility for the ethical performance of the research, the welfare of the animals involved, and adherence to any IACUC imposed conditions.

Name: IACUC #:

Department:

Address:

Title: e-mail address: Office Phone:

GWID: Cell/Emergency Phone:

MANDATORY COMPLIANCE COMPLETED(List date completed)

AALAS Learning Libraryhttp://www.aalaslearninglibrary.org/ (contact ARF for instructions)

Animal Handler Risk Assessment Form and GWUMC ARF Occupational Health Questionnaire

Citi Training (Completed before July 1, 2013) Chemical Hygiene/Hazardous Waste/Fire Safety(Last Monday of the month from1-3 p.m.)

BioSafety Training (last Monday of Month from 1-3 p.m.)

If IACUC species specific training is not available, please indicate training provided and by whom person will be trained.

PROCEDURES TO BE PERFORMED

Husbandry Anesthesia Catheterization

Surgery Non-Surgical Procedure Instrumentation

Surgical assistance Euthanasia Sample collection

OTHER PROCEDURES (PLEASE LIST)

Does he/she have experience with this species and the procedures he/she will be performing? YES NO

If yes, describe the relevant (species/procedures) training of this person enabling them to conduct the procedures described in this proposal and to use the animal species chosen.

If no, who will be responsible for training him/her in the specific procedures listed on the protocol?

Describe relevant professional training or degree:

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