INSTRUCTIONS FOR SUBMITTING THE ANIMAL USE PROPOSAL FORM
Version 01/2003
All research, teaching, and training activities at the University of South Carolina that use vertebrate animals must receive approval from the Institutional Animal Care and Use Committee (IACUC). To fulfill this requirement, the principal investigator must submit a completed Animal Use Proposal (AUP) Form for IACUC review and approval. The AUP, once approved, should be regarded as the investigator's contract with the University and the public to conduct animal activities in conformance with applicable laws, regulations, and sound scientific practices.
In preparing your AUP, a consultation with the Attending Veterinarian (AV) is highly recommended, especially if there is surgery involved. The AV will be able to assist with the appropriate medications (analgesics and anesthetics), intra-, and post-operative care, and, method of euthanasia. Oftentimes, a prereview of the animal proposal will help speed up the review process. Though not a complete guarantee for approval, a prereview helps to identify and clarify areas in the written proposal that need to be changed or revised prior to formal review by the committee.
Read all the instructions before completing the form. There are specific instructions, suggestions, and important information that appear in red type that are intended to assist the user in filling out the AUP. If you have any question, comment, or suggestion about the preparation and submission of the animal proposal, or if you would like to seek assistance prior to submission, please call or e-mail the IACUC at 777-8106 or .
To get started, download this Word-based form, and save it to your computer. This document is protected for form changes. User can only type in the responses in the form fields that are provided. No change in the form's standard elements or layout can be made. Each required Appendix should be downloaded separately. Download the form each time you need to use it since corrections or changes may have been made since the last time you used it.
IMPORTANT:
1. If funding agency is the National Institutes of Health (NIH), a complete copy of the approved grant application should accompany the AUP.
2. Proposals are reviewed in the regular IACUC monthly meeting. These meetings are normally scheduled on the first Thursday of each month. All proposals must be received at least ten (10) days before the scheduled monthly meeting. Proposals submitted after the deadline will ordinarily be held until the next regularly scheduled IACUC meeting.
3. Submit the signed original copy of AUP to: The IACUC, c/o Animal Resource Facilities (ARF), Graduate Science Research Center, Suite 102.
4. All sections of the application must be completed within the form field provided. Do not leave any field empty. If a specific section does not apply to your project, please indicate that it is not applicable (NA). To select a box, position the cursor on the desired box, and click. To deselect, click again. Simply press the tab key to move from one form field to the next. Do not double space your text.
Be prompt!! The earlier you can turn in your AUP, the more likely it can be prereviewed and appropriate changes made. Be complete!! All items should be answered. If a particular item in the AUP form does not apply to your study, please indicate that it is not applicable (NA). Be consistent!! Prior to submitting your proposal, ensure that all information you have provided is consistent throughout.
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ANIMAL USE PROPOSAL
Important: READ CAREFULLY
All sections of this Animal Use Proposal (AUP) must be completed within the form field provided. If a specific section does not apply to your project, please indicate that it is not applicable (NA). All procedures that involve the use of animals should be described in this proposal. Remember: If a procedure is not described in this proposal, then it is not IACUC-approved.
Before submitting the proposal, check to ensure that you are using the current form and that the required Appendices are completed and attached.
PRINCIPAL INVESTIGATOR (PI)
Name of PI: This is the responsible individual. S/he must be a full time USC Faculty.Department: Should be the PI's primary appointment.
Telephone Number: Daytime, Mon-Fri / Fax Number:
E-mail: / Emergency Phone Number: Evenings & weekends
PROJECT INFORMATION
Project Title:Project Type: New Renewal - Previous AUP Number: Teaching
To select a box, position the cursor on the desired box, and click. To deselect, click again.
Funding Source: If funding source is the National Institutes of Health, attach a complete copy of the approved grant application.
Grant Title (if different from Project Title): Enter the exact title of the grant as submitted or funded. The IACUC must be able to match the grant with the AUP. Leave empty if exactly the same as AUP Title.
Grant Number: Not the SPAR #. Write NA if there is no external funding source or grant number.
Duration of Project: Indicate # of years/months needed to complete the project. The maximum duration for any project cannot exceed three (3) years from the date the project was approved.
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INVESTIGATOR'S ASSURANCE
PROJECT TITLE: Type complete title here. The PI should carefully read and understand the following assurances before checking each box and affixing his/her signature below.
As the principal investigator of this proposed project and by affixing my signature below,
I assure that all the information contained in this Animal Use Proposal is true and all the animal procedures described for this study accurately summarize the nature and extent of the proposed use of animals. If this project is to be funded by extramural source, I further assure that this proposal accurately reflects all procedures involving laboratory animals described in the grant application to the funding agency.
I agree to abide by the provisions of the Guide for the Care and Use of Laboratory Animals (National Research Council, National Academy of Press 1996), the Animal Welfare Act
(PL 89-544 and Amendments), and the University of South Carolina policies for the care
and use of animals.
I certify that this project does not unnecessarily duplicate previously reported experimental work.
I assure that every effort has been made to minimize the number of animals used.
I assure that every effort has been made to reduce the amount of pain, distress, and/or discomfort these animals must experience. I understand that if I cannot be contacted in the event that animals in this project show evidence of distress, illness, or pain, emergency care, including euthanasia if necessary will be administered at the discretion of the veterinary medical staff.
I will notify the IACUC regarding any unexpected study results that impact the health and well-being of the animals.
I am aware that no change(s) to the final approved proposal will be initiated without prior written approval from the IACUC.
I understand that approval of this proposal is for a maximum of three (3) years. If animal work on the project is to continue beyond three years, a new Animal Use Proposal must be submitted. An annual review is required.
Printed Name: Type complete name here, and sign and date below.
Principal Investigator Date
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SECTION I. ANIMAL USE PROCEDURES CHECKLIST
Respond to all items in the table. Every animal procedure involved should be completely described in Section III. Some procedures require the completion of an Appendix or of specific sections (see last column).
ANIMAL PROCEDURE(Please mark all procedures that apply to each species.) / SPECIES
(Provide animal species below) / REQUIRED TO COMPLETE
Blood sampling/collection / Section VI.1
Other bodily fluid and tissue sampling before euthanasia
Behavioral studies
Monoclonal antibody production using the ascites method / Section VI.2
Monoclonal antibody production without using the ascites method / Section VI.2
Polyclonal antibody production / Section VI.2
Use of anesthetics, analgesics, tranquilizing or other therapeutic drugs (e.g., antibiotic) / Section VII
Administration of drugs or experimental agents b
Transplantation of tumors or cells into animals / Section VIII
Use of customized antibody c / Section IX
Special diet(s)
Field study/Trapping of animals / Section X
Tissue collection after euthanasia / Section XI
Non-survival surgery / Appendix A
Major survival surgery d / Appendix A
Multiple major survival surgery / Appendices A and B
Minor survival surgery / Appendix A
Prolonged physical restraint / Appendix B
Food and/or water restriction or deprivation / Appendix B
Aversive stimuli (e.g., shock) or other stressful procedures from which the animal cannot escape / Appendix B
Use of hazardous agents:
/ infectious organism / Appendix C
carcinogen
toxic chemical
radioisotope
recombinant DNA
Development of transgenic/knockout line / Appendix D
Death as an endpoint / Appendix B
Other procedures not described above
bThis excludes anesthetics, analgesics, tranquilizing or other therapeutic drugs (e.g., antibiotic).
cAn antibody is considered customized if a supplier or contractor produces antibody in an animal using antigen provided by or at the request of the PI. The OLAW considers antibody produced by a commercial supplier using its own resources and offered for general sale (e.g., through company catalog) as off-the-shelf reagent.
dA major survival surgery means a surgical intervention that penetrates or exposes a body cavity, or produces permanent impairment.
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SECTION II. LAY SUMMARY ON THE IMPORTANCE OF THE STUDY
Briefly explain in simple, non-technical language the aim of the project and its significance to human or animal health, the advancement of scientific knowledge, or the betterment of society. This section should be readily understandable to the general public. Avoid using highly technical terms. Your response here should be brief but easily understood by a non-scientist. If you are studying a human or animal disease or health concern, carefully explain the disease, what causes it, what therapy is currently used to treat it, and how the proposed study might better human or animal condition. For basic science studies, the importance of the proposed animal work can be amplified by linking it to the larger body of scientific work that it is supporting. If using or developing an animal model, you may explain how this model contributes to the hypothesis being tested or to the resolution of an important scientific dispute. Avoid the use of highly technical terms.
The following is an example response: In the United States, colon cancer incidence ranks third behind lung and breast/prostate cancer but is the second leading cause of cancer mortality. Colon
cancer is often asymptomatic until it has progressed beyond a treatable stage. In this project, the effects of ginkgo biloba extract, ginseng, and ginseng constituents, which are commonly consumed dietary supplements without adverse side effects, will be tested in a mouse model of colon cancer. If successful in this model, these compounds may then serve as potential agents for the prevention of initial or recurring colon tumors in humans with little or no toxicity or side effects.
SECTION III. DESCRIPTION OF THE ANIMAL PROCEDURES
For Renewals: Provide a short progress report on previous animal use and justify the need to request for additional animals to continue/complete the project. If this is a renewal of a previously approved AUP, provide a brief summary or progress report of the previous work, and why so many more animals are now being requested to continue/complete the project.
Briefly explain the experimental design and provide a complete description of all experimental procedures that will be performed on the animals. This description should allow the IACUC to fully understand the experimental course of an animal or group of animals from its entry into the experiment to the endpoint of the study. Flow charts, diagrams, and/or tables are greatly encouraged. The description of the animal procedures should be able to stand by itself. This means that the IACUC should not have to read another document, such as a grant application or a journal article, to understand what you propose. If performing surgery, the details of surgical procedures should appear in Appendix A but the general types of surgery, endpoint, and the final disposition of animals should be described here. To facilitate comprehension, all abbreviations and acronyms should be defined the first time they are used, or a list of abbreviations that appear at the beginning of this section may also suffice.
Remember: If a procedure is not described in this proposal, then it is not IACUC-approved. Performing animal procedures that have not been approved by the IACUC means that the activity is no longer in compliance with federal mandates.
The following is an example response:
APCMin/+ mice will be maintained on AIN93G purified rodent diet after weaning at 21 days of age. The mice will also be genoytyped by tailclipping at this age. Based on genotyping results, the APCMin/+ mice will be randomized into nine (9) groups at 28 days of age. Each group of 8 mice will receive a different test compound in their diet except the control. The dose for each compound will be determined by cell culture experiments using colon cancer cell lines. The diet groups are as follows:
Diet 1: EGb 761 (Ginkgo biloba extract) in AIN93G
Diet 2: Powdered ginseng in AIN93G
Diet 3: Ginsenoside Rb1 in AIN93G
Diet 4: Ginsenoside Rc in AIN93G
Diet 5: Ginsenoside Re in AIN93G
Diet 6: Ibuprofen in AIN93G
Diet 7: NS-398 in AIN93G
Diet 8: Curcumin in AIN93G
Diet 9: AIN93G only
Food and water will be supplied to the mice ad libitum. At 100 days of age, the mice will be sacrificed by carbon dioxide overdose. The intestines will be removed from the animals and the tumors will be counted. The animals are expected to develop benign intestinal tumors but will not experience any pain or discomfort due to these tumors. The animals will be monitored daily for any signs of moribundity, which include the following criteria: 5% weight loss, appetite loss, labored breathing, failure to groom, unkempt appearance, vocalization, self-mutilation, abnormal resting posture, loss of mobility, and guarding/protection of painful area. Should signs of moribundity arise, the experiment will be terminated. Due to the short duration of the experiment, such incidences are unlikely. The mice will be monitored on a daily basis.