Animal Use Protocol Application (rev. 2/7/06)

Download form as a Word document. Please follow the separate detailed Instructions for this Application Form.

Before submitting your Project Application to University Research, email it to the Attending Veterinarian, Dr. John Young, for Pre-Review.

Section Instructions

PROJECT TITLE: ________________________________________________________

PROJECT DATES: From_______ To_______

Funding Source: ____________

Name of Principal Investigator:____________

Department:____________ Telephone:_____ Email:_____ FAX:_____

Has this proposal been reviewed previously by the IACUC? Y/N _____

If yes, list IACUC number:_______

Has this proposal been reviewed previously by an IACUC at another institution?

Y/N _____ If yes, at what institution?______________________

The activities described in this application are consistent with those described in all related grants and contracts.

Signature:__________________________________ Date: ____________

I. PROJECT TYPE ( Section Instructions )

Student Classroom Teaching _____

Research _____

Training _____

Note: If observational purposes only, fill out Animal Observation Form instead.

II. PROJECT SUMMARY

A. Rationale and significance of this project:

B. Procedures involving animal subjects:

C. Definitions of technical terms:

III. PERSONNEL AND QUALIFICATIONS ( Section Instructions )

A. Include all of the following information in Section A. for every individual working directly with animals. If more than one person will be working with animals, please copy and paste an additional section for each. All personnel will receive a copy of the protocol.

• Name ________________________________________and Degrees__________
• Dept. /Div. ___________________________________
• [ ] P. I. (Named on Page One) [ ] Coinvestigator [ ] Lab. Tech.
• Phones: Office _______ Lab ______ Home ______________

• [ ] Anesthesia _____________ Qualifications: ______________

• [ ] Surgical Procedures _____________ Qualifications: ______________
• [ ] Non-Surgical Procedures ______________ Qualifications: ______________
• [ ] Euthanasia _____________ Qualifications: ______________

B. Individual(s) to be contacted in case of animal health emergency:

• Name: _______________________________
• Telephone Numbers: ________________________

IV. JUSTIFICATION FOR USE OF PROPOSED ANIMAL MODEL (Section Instructions)

A. The following information sources were used in an attempt to identify viable alternatives to the proposed animal model and avoid unnecessary duplication of the experiments (check all that apply):

[ ]MEDLINE

[ ]WEB OF SCIENCE

[ ]BIOLOGICAL ABSTRACTS

[ ]CRISP

[ ]AGRICOLA (National Agricultural Library)

[ ]LITERATURE AWARENESS SERVICE (Specify)_______

[ ]PROFESSIONAL JOURNALS (Specify)_____

[ ]PROFESSIONAL MEETINGS (Specify)_____

[ ]PERSONAL COMMUNICATIONS WITH COLLEAGUES (Specify)_____

[ ]Other (Specify)____________

For literature searches, the following Keywords were used:

______________________________________________________________

B. Alternatives:

• Could the proposed work be accomplished in clinical studies or with human tissue in compliance with ethical and regulatory standards?
  Y/N _____
• Could the proposed work be accomplished through computer simulation?
  Y/N _____
• Could the proposed work be accomplished with established cell lines?
  Y/N _____
• Could the proposed work be accomplished using animal tissues or primary cell lines obtained from other CSU LONG BEACH researchers?
  Y/N _____
  (If animal tissues could be used, consult the Animal Resources Office at x54459.)

C. Written, narrative assurance that alternatives were considered and found not suitable and that the activities do not unnecessarily duplicate previous experiments conducted by you or others. (Use sample narrative in Instructions, if appropriate.)

V. DESCRIPTION OF ANIMAL SUBJECTS (Section Instructions )

A. Species: ______________________________

B. Strain(s) or Breed(s): ___________________________

C. Sex: _________

D. Age: ___________________

E. Weight: _____________________

F. Procurement Source:

• [ ] External Vendor
• [ ] In-House Breeding
• [ ] Other (Specify):__________________

Note: If unsure, call Ext. 54459, Animal Resources.

G. Are special permits required for trapping, fishing, housing, or importing animals? Y/N_____
If yes, I assure that required permits are on file for inspection by the

IACUC.

H. Animal Use Sites:

Building: __________ Room: _____

Other:________________________

I. State Special Needs (Housing, Lighting, Diet, Sanitation, Etc.):

VI. DESCRIPTION OF SURGICAL PROCEDURES (Section Instructions)

A. Does this study involve surgical procedures? Y/N _____

[If yes, complete this section (Section VI). If no, skip Section VI and go directly to Section VII.]

B. Where will surgery take place?

Bldg: __________ Room: _____

Other:_____________________

C. Is aseptic technique practiced?
Y/N _____

D. Is the surgery survival (animal regains consciousness)?
Y/N _____

Is the surgery non-survival (animal euthanized under anesthesia)?
Y/N _____

Is more than one survival surgical procedure to be performed on any animal?
Y/N _____ If yes, indicate the time interval between surgeries and justify the need for multiple survival surgeries.

E. Give a brief description of all immediate presurgical and surgical procedures in chronological order.

F. Post-operative Period (Note: if all procedures are nonsurvival, check N/A and proceed directly to Item G. )

1. N/A _____
2. Where will animals recover? Bldg: __________ Room: _____
3. Describe supportive care and identify by name who will administer this care.
4. Will antibiotic or analgesic therapy be used?
   Y/N _____ If yes, indicate agent, dosage, duration, frequency and route of administration.

G. Chemicals, agents, devices, medications, etc. employed or evaluated during surgical procedures. If more substances are to be employed or evaluated, please complete an additional section for each (Substance 2, 3, etc.)

Substance # ___: _________________________

• When given?
• Duration, frequency & route:
• Dosage (Unit Per Body Weight):
• Number of animals receiving substance:
• Expected experimental effect on animal:
• Expected detrimental effect on animal:

If the researcher is administering a control substance which requires a DEA permit, please indicate the expiration date of the current permit and the limitations it imposes on the person registered.

VII. EXPERIMENTAL PROCEDURES NOT INVOLVING SURGERY AND/OR EUTHANASIA (Section Instructions )

A. Does this study involve animal use other than surgery and/or euthanasia?
Y/N _____

[If "yes," complete this section (Section VII). If "no," skip Section VII. and go directly to Section VIII.]

B. Chronological Description of All Non-surgical Procedures

C. Medications, chemicals, special diets, devices, anesthetics, sedatives, tranquilizers, etc. employed or evaluated in non-surgical procedures. If more than one substance is to be employed or evaluated, please complete an additional section for each (substance 2, 3, etc.)

Substance # ____: ________________________

• When given?
• Duration, Frequency & Route:
• Dosage (Unit Per Body Weight):
• Number of Animals Receiving Substance:
• Expected Experimental Effect on Animal:
• Expected Detrimental Effect on Animal:

VIII. BIOHAZARDOUS/RADIOACTIVE MATERIALS (Section Instructions )

A. If you plan on using biohazardous materials in your project, you must contact the Science Safety Office at x55623 prior to submitting this application to the IACUC.

Not applicable: _____.

B. If you plan on using carcinogenic materials in your project, you must contact the Science Safety Office at x55623 prior to submitting this application to the IACUC.

Not applicable: _____.

C. If your project requires the use of radioactive materials or radiation-producing devices on campus premises, you must contact the Campus Radiation Safety Office at x55623. The IACUC will not proceed with the review process until Radiation Safety has approved the use of these substances. Attach approval.

Not applicable: _____. Go to Section IX.

D. Will affected animals be housed in the Vivarium after treatment? Y/N _____

E. Identity of Biohazard, Carcinogen, Radioisotope or Radiation Dose, if any:

F. Description of Use and Precautions, if any:

G. Responsible Individual, if any: ___________________________

IX. SPECIAL CONSIDERATIONS (Section Instructions )

A. Are procedures to be employed that are intended to study pain?
Y/N _____ If yes, describe and justify.

B. Will animals undergo prolonged (more than one hour) restraint.
Y/N _____ If "yes," describe procedure, including the time period of restraint, and justify the necessity for the procedure.

C. Are any animals expected to die other than by euthanasia (e. g. , lethal dose studies, intraoperative mortality, adverse response to medication, aging, etc.)?
Y/N _____ If yes, give expected numbers (or % of total animals) and describe the circumstances under which they may die.

D. Describe the steps to be taken if animals become sick or injured unexpectedly.

• [ ]Veterinarian will be consulted.
• [ ]Other (please explain)

E. Describe the steps to be taken if animals expire unexpectedly.

• [ ]Veterinarian will be consulted.
• [ ]Other (please explain)

F. Disposition of animals upon completion of study. Note: Dead animals must be transported separately from live animals. Contact the Animal Resources Office at x54459 for proper disposal procedures.

1. If animals are to be euthanized, describe procedures and list agents, dosages and routes of administration.

2. Are these procedures in compliance with the current American Veterinary Medical Association recommendations for euthanasia?
Y/N _____

3. If the animals are alive at the completion of the study, describe what will be done with them. If animals are euthanized, check "N/A. " N/A _____

G. Is any veterinary assistance desired for this research project?
Y/N ______

X. JUSTIFICATION OF ANIMAL NUMBERS (Section Instructions )

A. What best describes your study?

1. [ ] Instructional/demonstration exercise.

2. [ ] Research Project

3. [ ] Teaching or Training: Animals in this study will be used only for training purposes. If this item is checked, proceed directly to Item X. E.

4. [ ] Other, please explain:

B. Specify each group of animals and the assigned N (number of animals) per group.

Group Specification: n = _____ per group (initial)

C. Total number of animals N = ________ combined from all groups listed in Item B.

D. What is the justification of your sample size?

1. [ ] Pilot study

2. [ ] Based on numbers of students expected. (Explain here):

3. [ ] Based on statistical analysis:

• [ ]Analysis has been performed (attach statistical analysis).
• [ ]Based on prior protocols (attach statistical analysis).

4. [ ] Based on other methods (show calculations and reasoning).

E. Describe training projects (Only if X.A.3. is checked above): N/A _____

1. How many trainees do you anticipate per year?

2. How many animals per trainee (or trainees/animal) will be needed? (Show calculations and reasoning.)