ISU Animal Care & Use Review Form
Federal animal welfare regulations require that the Institutional Animal Care and Use Committee (IACUC) must review and approve activities involving the use of vertebrate animals prior to their initiation. This includes animals used for experimental method development or for instructional purposes. In addition, approved protocols for ongoing activities must be reviewed by the IACUC at least annually. IACUC will not review any protocols without documentation of mandatory training.
SECTION I: GENERAL INFORMATIONPrincipal Investigator (PI): Click here to enter text. ☐ Faculty ☐ Staff
E-mail: Click here to enter text. Department: Choose an item.
Phone number: Click here to enter text.
Protocol Title: Click here to enter text.
Is this research part of a thesis or dissertation proposal: ☐ Yes ☐ No
A. Key Personnel
List all key project personnel who have live animal contact and their relevant experience. This information is intended to inform the committee of the training and background related to the specific procedures that each person will perform on the project. An additional sheet may be attached.
Name / Status / Specific Duties on Project / Training & Experience Related to Procedures Performed
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Does your research involve supervised students? ☐ Yes ☐ No
If Yes, how will your training be conducted: Choose an item.
B. Funding InformationIs this project externally funded: ☐ Yes ☐ No
If yes, ☐ Federally Funded ☐ Not Federally Funded
Source of funding:
RSP number: Click here to enter text.
If funded by NIH or USDA please upload the animal portion of the grant with this submission. A grant and protocol comparison will be completed.
C. Project Information
1. Does this project involve any of the following? ☐ Yes ☐ No
· Use of recombinant or synthetic nucleic acid molecules, including transgenic animals or plants
· Use of human or animal pathogens (e.g., bacteria, viruses, prions, parasites)
· Use of soil, seed, plants, plant pathogens (e.g., bacteria, viruses, or parasites) or other material received under a USDA APHIS compliance agreement or permit
· Use of biological toxins
· Administration of experimental biological products to animals
· Use of radioactivity, MRI, x-ray, DEXA, CT, C ARM, fluoroscopy or other radiation producing devices
If Yes is checked, choose one of the two options listed below.
Option 1:
If you have prior IBC/RSC approval to work with any of the above please provide the below information.
Protocol Number / Radiation Permit Number / TitleClick here to enter text. / Click here to enter text.
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Complete an IBC Modification Form and submit it to the IBC Committee to link the previously approved IBC protocol if there are limited changes needed, such as one or more of the following:
· Change in inoculation method
· Change in species of animals
· Addition of a pathogen or toxin
· Change in location of the study
· Change in personnel
· Change in isotope
Option 2:
If you do not have IBC and/or RSC approval you will need to submit a new IBC and/or RSC protocol to the appropriate committee.
2. Will this project involve any of the following? ☐ Yes* ☐No
· Anesthetic gas usage
· Bedding or cage changing done by PI or PI’s staff
· Highly toxic chemicals
· Human cell lines or tissue culture (primary OR immortalized)
· Human blood components, body fluid or tissues
· Permit requirements (this does not include permits needed for wildlife collection)
· Sending or receiving biological samples
*If Yes is checked, please answer the questions in SECTION III: Environmental Health and Safety.
Certification☐ Yes ☐No
☐ N/A / I certify that the information provided in this application is complete and accurate and consistent with any proposal submitted to external funding agencies.
☐ Yes ☐No / I certify that this project does not unnecessarily duplicate previous experiments involving animals.
☐ Yes ☐No / I agree that all activities will be performed in accordance with all applicable federal, state, local and Illinois State University policies.
☐ Yes ☐No
☐ N/A / I will follow applicable biosafety level requirements; comply with all shipping requirements and required waste management practices.
☐ Yes ☐No / I will ensure that all personnel have appropriate training and that training is documented for topics not limited to: biosafety principles and techniques, accidental spills, shipping regulations, zoonotic disease, radioactive material handling, proper handling of biohazardous material and waste management, and animal welfare regulations.
☐ Yes ☐No / If I wish to make any changes to an approved protocol, I will first submit and receive approval by the appropriate committee(s) before the changes are implemented.
☐ Yes ☐No / I will not withhold medical care for animals. Consulting Veterinarian will be contacted as appropriate.
☐ Yes ☐No / I will report ANY unexpected illness, injury or death to Research Ethics and Compliance in accordance with the Adverse Event SOP.
☐ Yes ☐No / I will have necropsies performed on animals that die unexpectedly if requested by Attending Veterinarian.
☐ Yes ☐No / I agree that I will not begin this project until receipt of official approval from all appropriate committee(s).
☐ Yes ☐No / I understand that ISU has a Public Health Service Animal Welfare Assurance with which they must comply.
☐ Yes ☐No / If another institution is involved in this project current IACUC approval letters from that institution are uploaded with this submission.
☐ Yes ☐No / I understand I am responsible for the supervision, training, and work of my students and staff.
SECTION II: ANIMAL CARE AND USE INFORMATION
Please note: All descriptions, to the extent possible, must be in lay person’s terms. Any departures from the Guide For the Care and Use of Laboratory Animals or Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching must be described and sufficiently justified in this protocol. Common departures include use of non pharmaceutical grade compounds and methods of euthanasia.
A. Study Objective
Provide an overall summary of the project and briefly explain in language understandable to the general public the specific aim(s) of the study. Define any acronyms.
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B. Benefit
Explain in language understandable to the general public how the information gained in this study will benefit human or animal health, the advancement of knowledge, and/or serve the good of society. This information is intended to inform the committee why it is important to conduct this study. For courses, include how this experience will benefit students.
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C. Species
Genus/Species or Common Name / Strain, Subspecies or Breed / Total Number to Be Used in Entire Project / Pain Classification* / Approximate Age, Weight or Size / Sex
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· Classification C-No pain, distress, or use of pain-killing drugs. (i.e. post-mortem tissue harvest; and routine procedures causing only transitory discomfort such as venipuncture, injections, ear tagging, use of non-inflammatory adjuvants)
· Classification D-Pain/distress with appropriate analgesic/anesthesia/tranquilizers. Procedures involving accompanying pain or distress to the animals and for which the appropriate anesthetic (for surgery), analgesic (for inflammation or pain) or tranquilizing drugs are used. (YOU MUST COMPLETE APPENDIX B)
· Classification E-Pain/distress without appropriate analgesic/anesthesia/tranquilizers. Procedures involving accompanying pain or distress to the animals and for which the appropriate anesthetic, analgesics or tranquilizing drugs are not used.
· For Pain Class D or E, Section G of this form must be completed.
SOURCE OF SPECIES / NUMBER OF EACH SPECIES☐ Purchased through an approved commercial vendor
Vendor: Click here to enter text. / Number: Click here to enter text.
☐ Agriculture Production Animals (ISU Farm) / Number:Click here to enter text.
☐ Privately owned / Number:Click here to enter text.
☐ Transferred from another study. / Number:Click here to enter text.
☐ Other- source Click here to enter text. / Number:Click here to enter text.
☐ Captured from the wild* / Number: Click here to enter text.
* For wild caught animals in the box below please list all required permits and permit numbers and upload a copy of each permit. Describe the method of capture to be used and cite the literature reference if the method is standard procedure or complete details if it is a nonstandard method. Include an estimate of the expected mortality for each capture method.
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D. Rationale for Animal Use1. Explain your rationale for using live animals and why the species proposed is appropriate for this study.
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a. What alternatives- refinement, replacement or reduction- to the use of live animals have been considered, and why were they not appropriate?
This question is designed to inform the committee of the alternatives that were considered, why it was determined that they were not useful for this study, why a species lower on the phylogenetic scale could not be used, if methods have been incorporated into the study to reduce animal numbers or refine techniques, and an explanation of those methods.
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b. Describe how the number of animals needed for this study was determined.
The Guide recommends that the number of animals should be the minimum number required to obtain statistically valid results.
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E. Breeding of Animals1. Non Transgenic/Knockout Breeding Program
a. Please provide a justification for the need for breeding (e.g. animals are not commercially available, in utero studies, reproduction studies etc.)
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b. List the species and strain/stocks of animals to be produces in your breeding program:
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c. Anticipated total number of offspring for each species that will be produced (per year):
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d. Anticipated number of offspring that will be used for experiments:
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e. What will be done with the surplus?
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2. Transgenic/Knockout Breeding Programs
a. DNA/transgene or gene to be disrupted:
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b. Anticipated consequences of the animal genetic manipulation:
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c. Method of monitoring presence of transgene in the animals.
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d. Describe any special care or monitoring that may be required:
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e. Who will perform this monitoring and care?
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f. What is the disposition of the founders and how long will they be maintained?
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F. IACUC Approved Housing Requirements1. Housing location(s) and any special housing, caging, or bedding needs. (If wild caught animals are held in captivity longer than necessary to band, mark, measure, or take blood, teeth, tissue samples, indicate the type of enclosure or cage and care to be provided under section a below.)
a. Where will your animals to be housed? Choose an item.
Room number if applicable: Click here to enter text.
If animals are client-owned, attach a copy of the client-owned consent form to be used. Singed copies of individual consent forms must be maintained by the PI. Copies of signed site consent forms must be uploaded to your protocol as a modification request.
b. You must be preapproved to house animals outside IACUC approved facilities longer than 12 hours. If animals will be housed outside of an ISU-approved housing facility for more than 12 hours, please provide the following:
b.i. Alternate housing location, including the building and room number.
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b.ii. Access control (how is access limited):
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b.iii. Caging that will be used (give size, material etc.):
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b.iv. Personnel responsible for care of these animals. (Animals must be observed
every day, including weekends and holidays.) Provide documentation for monitoring.
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b.v. Food (type, brand, source, how and where stored):
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b.vi. Water (source-must be potable, how supplied to the animals):
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b.vii. Bedding- type, how used, how and where stored, frequency of changes.
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b.viii. Describe the sanitation procedures and equipment used for the
primary enclosure/cages and the feeders and watering devices
(including frequency).
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b.ix. Describe the handling, storage, frequency of disposal, and final disposal
location for soiled bedding, refuse and of animal carcasses.
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b.x. Procedures for providing emergency weekend and holiday care.
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b.xi. Provisions for veterinary care and supervision:
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b.xii. Will there be any significant departure from their normal environment
(temperature, humidity, ventilation, illumination, forced exercise, etc.)
☐No ☐Yes
If yes: Describe the conditions:
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Duration:
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Rationale for departure from normal environment:
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c. Will animals be transferred between institutions? ☐ Yes ☐ No
If Yes, please list names of institutions other than ISU those animals will visit:
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2. The 8th edition of the Guide for the Care and Use of Laboratory Animals requires social animals (i.e., mice, rats, pigs, rabbits, cows, hamsters, dogs, cats, sheep, goats, etc.) to be socially housed. Therefore, all social animals will be socially housed. However, if animals need to be singly housed for the project (e.g., scientific need, required after surgery, etc.)
a) Will animals on this study be singly housed? ☐ Yes ☐ No
If Yes, is selected, please provide strong justification for your request:
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b) Will you accept standard animal enrichment? ☐ Yes ☐ No
If No, explain why:
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3. List all building and room numbers where live animal procedures outlined in this protocol will take place.
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a. Minimal space requirements from one of the following resources will be followed for alternative housing: ☐ Yes
1. The Animal Welfare Act
2. The Guide For the Care and Use of Laboratory Animals
3. The Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching
If none of these are used, provide justification.
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4. Please indicate what will happen to the animals at the end of the project. Please designate the number of animals for each category.
☐ Slaughtered. Number: Click here to enter text.
☐ Sold. Number:
☐ Returned to colony, herd, or owner. Number:
☐ Transferred to another project. Number: Please provide protocol number: Click here to enter text.
☐ Other Specify: Click here to enter text. Number:
☐ Euthanized. Number: Where will this be performed? Click here to enter text.
Who will dispose of the carcasses: Click here to enter text.
G. Consideration of Alternatives for Pain Classification D or E
If any animals in this project will be in category D or E, federal regulations require consideration of alternatives to procedures that may cause more than momentary pain/distress. Include a minimum of three databases searched using keywords of alternative, refinement, replacement, reduction, and any additional words relevant to your study.
Search 1
Database Searched:
Period covered by search:
Date of search:
Keywords and/or search strategy used: alternative, refinement, replacement, reduction and
Were alternatives found? ☐ Yes ☐ No
The potential alternatives and why they are or are not applicable:
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Search 2
Database Searched:
Period covered by search:
Date of search:
Keywords and/or search strategy used: alternative, refinement, replacement, reduction and
Were alternatives found? ☐ Yes ☐ No
The potential alternatives and why they are or are not applicable:
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Search 3
Database Searched:
Period covered by search:
Date of search:
Keywords and/or search strategy used: alternative, refinement, replacement, reduction and
Were alternatives found? ☐ Yes ☐ No
The potential alternatives and why they are or are not applicable:
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H. Description of Experimental Design and Animal Procedures
Please do not respond to any questions with the statement “industry practice” as the community and nonscientist members of the committee will not be familiar with industry practice and will not have the information necessary to vote. Please use layperson’s terms to the extent possible. A diagram or chart may be helpful to explain complex designs.