RESEARCH
USE ONLY / Review Date: / Committee ID:
Approval Date: / Length of Approval:
Continuing Review Date: / FULL Committee Review Date:
ISU IACUC/IBC PROTOCOL REVIEW FORM
ANIMAL BREEDING COLONY
SECTION i: GENERAL INFORMATION
Principal Investigator (PI): / Phone: / Fax:Degrees: / Correspondence Address:
Department: / E-mail Address:
Center/Institute: / College:
PI Level: Faculty Staff Postdoctoral Graduate Student Undergraduate Student
Alternate Contact Person: / Email Address:
Correspondence Address: / Phone:
Title of breeding colony (species / strain of animal):
Assurance
- Yes No I certify that the information provided in this application is complete and accurate and
consistent with any proposal(s) submitted to external funding agencies.
- Yes No I certify that this project does not unnecessarily duplicate previous experiments involving
animals.
- Yes No I agree to establish and manage the colony according to principles of animal reduction and
genetic management as described in the Guide (pages 76-77).
- Yes No I agree to provide proper surveillance of this project to ensure that the rights and welfare of the
animal subjects are protected. I will report any problems to the appropriate compliance review committee(s).
- Yes No I agree that I will not begin this project until receipt of official approval from all appropriate
committee(s).
- Yes No I agree that modifications to the originally approved project will not take place without prior
review and approval by the appropriate committee(s), and that all activities will be performed
in accordance with all applicable federal, state, local, and Iowa State University policies.
- Yes No I will ensure that all personnel have appropriate training, including but not limited to biosafety
principles and techniques, accidental spills, shipping regulations, proper handling of
biohazardous materials and waste management, animal welfare regulations, and animal
handling training.
- Yes No I will follow applicable biosafety level requirements, comply with all shipping requirements
and required waste management practices.
- Yes No I will ensure all personnel performing euthanasia have been properly trained and training will
be documented.
- Yes No I ensure that all personnel are provided with information regarding zoonotic diseases applicable
to this study.
- Yes No I will contact the Attending Veterinarian whenever ANY unexpected deaths or events occur
(515-294-0266 or 515-509-7264). These reports to the AV must be made within 24 hours of occurrence and based on AV consultation, an Unanticipated Event Form must be submitted within 7 days of the occurrence. Depending on circumstances, non-timely submission of this form may lead to potential noncompliance.
- Yes No I will have necropsies performed on animals that die unexpectedly.
- Yes No I understand that ISU has a Public Health Service Animal Welfare Assurance with which they must comply. More information regarding this assurance can be obtained by contacting the IACUC office at .
- Yes No N/AIf animals will be housed in facilities not managed by LAR, it is the responsibility of the PI to obtain permission from the supervisor of the specific animal housing facilities and to verify that the facilities meet federal standards. I acknowledge that I have obtained permission and facilities meet federal standards.
Signatures
______
Signature of Principal InvestigatorDate
Signature of Department Chair Date
For Office for Responsible Research/IACUC Use Only:
Chair’s signature below indicates that the project has been approved by the IACUC.
______
IACUC Approval Signature Date
ForOffice for Responsible Research/IBC Use Only:
Chair’s signature below indicates that the project has been approved by the IBC.
IBC Approval SignatureDate
PLEASE NOTE: Any changes to an approved protocol must be submitted to the appropriate committee(s)
before the changes may be implemented.
SECTION II: IACUC INFORMATION
1)YesNo Is this a new colony? If No, please specify previous log number: .
2)What species and strain/breed of animals are included in the colony?
3)Why is it necessary to maintain a colony of these animals?
Animals that are given the designation of “irreplaceable” by the ISU IACUC will be given first priority for
evacuation in the case of a disaster.
All animals are assumed to be replaceable unless justified in consultation with the IACUC or ISU Attending Veterinarian. Animals determined to be irreplaceable will be prioritized for removal in the following order: 1) those that are unique, essential for long-term research, or available on a one-time basis only; 2) those that might be replaced with a similar strain; and 3) animals that are easily replaced.
3a) Do you wish to request an “irreplaceable” designation for animals on this protocol? Yes No
If Yes is marked, please justify why these animals should receive the “irreplaceable” status:
4)YesNo Will the colony be used by more than one investigator/instructor? If Yes, indicate the individuals who will use animals from this colony:
5)YesNo Will animals from the colony be used in more than one project? If Yes, list the log numbers of the projects/courses in which these animals will be used:
6)List all individuals who will have contact with the animals:
Name / Duties / Training & Experience Related to Procedures PerformedAdd New Row (double-click)
7)Veterinary care. (Veterinary care is available 24/7. LAR on call phone 515-290-3012 or the Attending Veterinarian at 515-509-7264.)
a)Please indicate the veterinarian(s) responsible for providing care. **If you will request controlled drugs from LAR, please list them as one of the veterinarians on the protocol.
b)List the individuals who are authorized to approve medical treatment or euthanasia. NOTE: If none of theindividuals listed can be contacted in a timely manner, the decision to treat or euthanize animals will be made by the LAR veterinary staff.
Name / Work # / Home # / E-mail AddressAdd New Row (double-click)
c)Please indicate desired plan of action in case of animal illness (e.g., initiate treatment, call investigator prior to initiating treatment, euthanize).
8)How many breeding animals and suckling will be maintained in the colony?
- Federal guidance indicates that if pre-weaned or weaned animals will be manipulated in any way, such as thymectomy, toe clip or ear notch for identification, tail tip excision for genotyping, or behavior tests, the number of manipulated animals must be included in the estimated number of animals used.
- If animals will be euthanized at, or prior to, weaning without any data collection or manipulation, their numbers are not counted.
To assist the IACUC in reviewing breeding colony forms, the following information should be included:
- Maximum estimated number of breeders needed to produce desired numbers
- Maximum estimated number of replacement breeders held (i.e., for rodents, this is usually 2 to 3 x number of breeders used at one time)
- Maximum estimated number of animals (pre-weaned, weaned, or adult) to be subject to manipulations
9)What is the source of the animals? (Check all that apply):
Procured through LAR
Bred or reared at ISU (Specify colony, herd, or farm of origin and facility manager)
Captured from wild
Other – Specify:
10)Specify the housing location(s) for the colony:
11)Describe the number of breeders and number of young per cage and specify if any special housing conditions (e.g., special caging, bedding, environmental requirements, etc.) will be necessary.
12)Describe the mating system to be used and any husbandry procedures which will be performed, including the number of females per male, continuous versus interrupted mating, or artificial insemination versus natural service.
13)How long will breeding animals be maintained in the colony? Specify the weaning age, separation of animals at weaning age, etc.
14)What criteria will be used for removing animals from the colony?
15)What will be done with surplus animals?
16)How will the colony be monitored? Note: The Guide for the Care and Use of Laboratory Animals states that the first offspring of a newly generated Genetically Modified Animal (GMA) line should be carefully observed from birth into early adulthood for signs of disease, pain, or distress.When the initial characterization of a GMA reveals a condition that negatively affects animal well-being, this should be reported to the IACUC.
17)When euthanasia is necessary, describe the method to be used including the agent, dosage (in mg/kg), and route ofadministration. Justify methods not consistent with the recommendations of the American Veterinary Medical Association Panel on Euthanasia.
17a) If you are using a barbiturate for euthanasia, please confirm you are using pharmaceutical grade. Yes
18)How will carcasses be disposed of following euthanasia?
Rendering
Incineration
Other – Specify:
YesNo Will this project involve the use of transgenic (including knockout) animals? If Yes is
checked, please proceed to Section III, Institutional Biosafety Committee Information.
SECTION III: IBC INFORMATION
Transgenic Animal Information
1)Describe how these animals are genetically altered.
2)Please indicate how these animals will be procured. This information is intended to inform the committee if animals will be purchased from a vendor, transferred from another institution, or produced here at ISU.
3)Describe the marking system to be used to individually identify all transgenic animals in this project and any resulting offspring. Appendix Q-II-A-1-b-(1) of the NIH Guidelines requires that “all genetically engineered neonates shall be permanently marked within 72 hours after birth, if their size permits. If their size does not permit marking, their containers should be marked. In addition, transgenic animals should contain distinct and biochemically assayable DNA sequences that allow identification of transgenic animals from among non-transgenic animals.”
4) Describe the type and frequency of evaluations to be performed on the animals in this project.
Biosafety Containment Level
5)Please check the federal guidelines applicable to the proposed project. The IBC Administrator (, 294-9581) can assist you in determining the proper guidelines. All guidelines are also available on the Internet.
For recombinant or synthetic nucleic acid molecules and/or transgenic animals, refer to theNIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. Please list the specific safety and/or containment practices to be followed for this project in the box below:
Please indicate proposed Biosafety containment level(s) to be used in this project. Refer to theNIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
rDNA Biosafety Level 1 (BL1)
rDNA Biosafety Level 2 (BL2)
rDNA Biosafety Level 3 (BL3)
rDNA Animal Biosafety Level 1 (BL1-N)
rDNA Animal Biosafety Level 2 (BL2-N)
rDNA Animal Biosafety Level 3 (BL3-N)
6)YesNoAre any permits required for this project?
If the appropriate permits have already been obtained, please list the applicable permit numbers:
Permit: Permit: Permit:
Please fax or attach copies of all required permits.
The Department of Environmental Health and Safety (EH&S, 294-5359) can assist you in determining permit requirements and obtaining any necessary permits. Permit requirement information is available on the Internet.
7)Describe the specific decontamination method(s) to be used for all biohazardous waste (except animal carcass disposal) and contaminated equipment. Decontamination methods may include autoclaving, chemical disinfections, etc. If a chemical disinfectant is used, state type and concentration. Please refer to the EH&S Sharps and Biohazardous Waste Procedureand the Sharps and Biohazardous Waste Disposal Flow Chartfor assistance.
Add New Row (double-click)
Procedures for Safety in Animal Facilities
8)Please check all personal protective equipment required in animal facilities:
Face shield/goggles/safety glasses (specify):
Boots/shoe covers
Coveralls/lab coat
Rain suit
Gloves
Head cover
Mouth/nose covering (specify type):
Other (specify):
9)Please describe any special precautions to be used in the animal facility: (e.g., shower in/out).
Study Location Information
10)Please list the location(s) where the animals will be housed.
BUILDING / ROOM NUMBER IF APPLICABLEAdd New Row (double-click)
11)List locations of biological safety equipment (for example, clean bench, biosafety cabinet, autoclave). Include most recent certification date for biosafety cabinets. Please enter “failed” if the cabinet did not pass certification testing.
(Required only for biosafety cabinets.)
Add New Row (double-click)
Disposal
12)Specify how the carcass will be disposed of following euthanasia:
Can be rendered
Must be incinerated (Per ISU EH&S Sharps and Biohazardous Waste Procedure, all sheep and goats and any animals infected with human pathogens must be incinerated.)
Other (specify):
Specify who will dispose of the carcasses:
Disposed of by key personnel
Disposed of by LAR personnel
Collected by Environmental Health and Safety
Other (specify):
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Office for Responsible Research
Revised: 5/31/2017