INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)
987830 Nebraska Medical Center
Omaha, NE 68198-7830
402/559-6046
Fax 402/559-3300
IACUC APPLICATION
FOR RODENT BREEDING COLONY
Section I-Administrative Data
1. Status:
New Submission
3 Year De novo Review of IACUC Protocol #:
Request for Change for IACUC Protocol#:
2. Title of Protocol:
3. Responsible Personnel
a. Principal Investigator (PI):
Is the PI a member of the UNMC or UNO faculty?
Yes
No
Faculty Advisor:
I have consulted with my Faculty Advisor and he/she has reviewed this submission.
b. Optional Administrative Contact. List ONE person, other than the PI, to be copied on all IACUC correspondence:
4. Funding Source. Check all that apply and/or provide the information requested.
PHS
Nebraska State Grant Funds (LB506)
NSF
Departmental/Internal Funds
Contract. Specify:
Other External Funds. Specify:
5. Unusual Deadlines or Considerations. Are there any unusual deadlines and/or considerations?
No
Yes
Specify:
Justify:
6. Certification of Principal Investigator
All activities on this project utilizing live vertebrate animals will be conducted in accordance with the PHS Policy on Humane Care and Use of Laboratory Animals, USDA Animal Welfare Act and Regulations, Guide for the Care and Use of Laboratory Animals, Association for Assessment and Accreditation of Laboratory Animal Care International, the UNMC/UNO Animal Welfare Assurance, and the Animal Care and Use Program Policies and SOPs located on the IACUC website www.unmc.edu/iacuc.
It is understood that IACUC approval is valid for a period of no more than 3 years following the date of original or continuing review. In addition, annual review is required for all protocols utilizing USDA covered species. It is further understood that if this project is to be or has been submitted for external funding the information presented on the application form reflects, accurately, the animal use in the grant application(s). It is the responsibility of the investigator(s) to communicate to the granting agency any change in scope in the research plan that may result from the IACUC review process.
My signature below or submission of this application indicates I have read the certification and that I will conduct the project in full accordance with it.
IACUC Application Rodent Breeding Colony_7.10.2013#s 1
______
Principal Investigator Signature Date
IACUC Application Rodent Breeding Colony_7.10.2013#s 1
Section II –Species Selection
1. Species-Enter the species (for rats and mice-include only the strain; genotype information will be addressed later) to be utilized on this project. Only one species is allowed per Rodent Breeding Colony Application.
Species2. Source of Animals. Select all that apply and provide requested information.
Approved commercial vendor. Vendor name:
Another institution. Institution name:
On campus breeding colony. IACUC Protocol #:
Section III-Overview
Instructions: In order to document official institutional approval of animal use, the IACUC requests the following information pursuant to its charge. This application is subject to on-site review by the PHS, USDA and AAALAC International. Consult with Comparative Medicine and the IACUC Administrative Office during completion of this form. Do not include information in a section that is not pertinent to that section.
· Do not refer to information in another section.
· Do not cut and paste from a grant application, journal article or abstract.
· Avoid excessive detail of assays not directly related to the use of animals (e.g., chemical assays, molecular biology, and in vitro tests).
· Avoid scientific terminology and/or jargon, or unexplained abbreviations; where use of such language is unavoidable, provide definitions of the term where first used.
· Include sufficient information to allow reviewers to conduct a final/harm benefit analysis to weigh the potential adverse effects of the study against the potential benefits that are likely to accrue as a result of the research.
1. Purpose of Maintaining a Breeding Colony. A breeding colony must be maintained because of the following (check all
that apply) Cost alone is not justification for maintaining a breeding colony.
The animals are not available commercially.
The animals are available commercially but not in sufficient number required.
The animals are available commercially but not in age required.
Other
Explain:
2. Genetically Engineered Animal Use. Will you be using genetically engineered animals? This includes animals with induced mutations, including transgenic, targeted mutations (knockouts or knockins), and retroviral, proviral, or chemically-induced mutations.
No
Yes
a. Source of genetically engineered animals. Check all that apply.
Colony managed by a UNMC/UNO PI or developed by the UNMC Transgenic Core.
Obtained from another institution.
Purchased from a commercial vendor (e.g., Charles River, Jackson Laboratory)
b. Genotype. Identify the genotype/s: For each genotype, briefly describe the genetic alteration/s:
c. Phenotype induction. Is an induction method necessary?
No gene is always “on”.
Yes mark all induction methods that apply.
Pharmacologically activated
Viral induced
Other:
d. Phenotypic expression. The phenotypic expression of these genetic alterations will likely result in:
No morphologic or functional impairment.
A potential for morphological or functional impairment. Address in detail in Section VII.
e. Special husbandry needs. Are any special animal care needs (e.g., feed, water, temperature, humidity, light, etc.) required for these genetically engineered animals?
No special husbandry needed.
Yes special care is required. Address in detail in Section VIII.
3. Immunodeficient Animal Use. Will you be using any immunodeficient animals?
No
Yes
a. Special husbandry needs. Are any special animal care needs (e.g., feed, water, temperature, humidity, light, etc.) required for these immundeficient animals?
No special husbandry needed.
Yes special care required. Address in detail in Section VIII.
Section IV- Justification of Number of Animals
1. Number of Animals Requested. Complete the following table. List the total number of founder animals needed to start the colony and the number of offspring you will be producing to transfer to experimental protocol(s) at weaning time. A separate breeding colony protocol is required for each species.
FOUNDERS / ON-SITE BREEDING# of founder animals needed to start the colony / # Animals to be transferred to experimental protocol(s)
IACUC Application Rodent Breeding Colony_7.10.2013#s 3
NOTE: All animals that will be used on an approved experimental protocol must be properly transferred to the experimental protocol through the CMMS system at rss.unmc.edu. Accurate records of the number of animals produced and their ultimate disposition (i.e., used in experiments, euthanized, died or retained for future breeding stock) should be maintained in your laboratory. For any increase in the estimated number of animals required for transfer to an experimental protocol, you will need to submit a Request for Change.
2. Number Justification. Provide scientific justification for the number of animals you have requested in the table, Section IV.1. The IACUC understands that you will not be able to give specific statistical justification as this is a request for breeding animals. However, you should be able to give an estimate of the number of founders needed and the reasoning behind that number. Please estimate the total number of offspring you need to produce in order to obtain the required number of experimental animals of the appropriate genotype. All experimental animals will need to be scientifically justified on the experimental protocol.
Section V-Procedures-Breeding Colony Management
1. Breeding Scheme to be Used. Select all that apply.
Monogamous
Harem
Trio
Polygamous
Timed mating
Other:
2. Weaning Schedule. Select at what age the animals will be weaned.
21 days of age or less
Older than 21 days
a. Indicate at what age the animals will be weaned:
b. Justify the need for delayed weaning:
3. Breeding Stock Selection. Describe the criteria you will use to select the future breeding stock.
4. Experimental Animal Selection. Describe the criteria you will use to select which animals are used for experiments.
5. Breeding Colony Maintenance. For purposes of CM management, how long do you intend to maintain the breeding colony?
6. Cage Density Management. Space requirements for breeding mice are outlined in the Policy for Cage Population Densities for Breeding Mice.
I assure the IACUC that I will adhere to the Policy for Cage Population Densities for Breeding Mice.
I request an exception to the Policy for Cage Population Densities for Breeding Mice.
Explain:
Not applicable, not a mouse protocol.
7. Animal Identification. Policy for Rodent Identification SOP on Rodent Identification Techniques
a. How will you ID the animals? Check all that apply.
Standard cage cards
Ear notch
Ear tag
Tattoo
Microchip
Other:
Toe Clip
Provide scientific justification for the use of toe clipping vs. other ID methods:
Toe Clip-within the first 7 days of life
Toe Clip-after the first 7 days of life. Requires the use of anesthesia.
Indicate what anesthetic/s will be used:
Agent / Dose (mg/kg) / RouteIACUC Application Rodent Breeding Colony_7.10.2013#s 4
b. Will you follow the SOP on Rodent Identification Techniques?
Yes
No, I request a deviation from the SOP on Rodent Identification Techniques.
Explain:
8. Animal Genotyping. Will you genotype the animals? Policy for Rodent Genotyping SOP on Rodent Genotyping Techniques
No, Genotyping is not necessary.
Yes
a. Methods of genotyping. Check all that apply.
Ear punch
Hair bulb
Fecal pellet
Buccal swab
Other:
Blood Sample-Describe method:
Will any sedatives, anesthesia, and/or analgesics be used to provide pain control and/or immobilization for the blood collection procedure?
No The blood collection procedure does not require sedatives, anesthesia or pain control.
Yes Intra-procedural drugs will be used. Indicate what agents will be used.
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Agent / Dose (mg/kg) / RouteIACUC Application Rodent Breeding Colony_7.10.2013#s 4
Tail Biopsy
Single Tail Biopsy-within the first 21 days of birth
Single Tail Biopsy- greater than 21 days of age
Provide scientific justification for the use of tail biopsy on animals greater than 21 days of age:
Indicate what anesthetic/s will be used:
Agent / Dose (mg/kg) / RouteIACUC Application Rodent Breeding Colony_7.10.2013#s 4
Multiple Tail Biopsies
Provide scientific justification for the use of multiple tail biopsies:
Indicate what anesthetic will be used:
Agent / Dose (mg/kg) / RouteIACUC Application Rodent Breeding Colony_7.10.2013#s 4
b. Incorrect genotype. What will be the disposition of the animals that do not have the desired genotype?
c. Will you follow the SOP on Rodent Genotyping Techniques?
Yes
No, I request a deviation from the SOP on Rodent Genotyping Techniques.
Explain:
9. Breeding Colony Endpoint Criteria. List the criteria for determining when the animals will be euthanized. Examples of appropriate criteria include the wrong genotype, retired breeders, infertility, etc.
Section VI- Additional Procedures
1. Additional Procedures. Will you be performing any other procedures, including surgeries, not previously discussed?
No Proceed to Section VII.
Yes Complete a-e.
a. Preparative regimen. Specify pre-procedural actions that will be taken to prepare the animal for the procedure/s. Do not include anesthesia or analgesia in this section. This may include but not limited to: placement of IV catheters, clipping of fur, aseptic preparation of surgical site, food/water withdrawal, etc.
b. Description of procedures: Describe with a reasonable degree of detail ALL non-surgical and surgical procedures to be performed. IF sedatives, anesthetics or analgesics are to be used, you may state so in the text BUT DO NOT list dosages in the text. In-vitro assays can be identified but not described in detail. If blood or tissue collection is proposed, state the source, method, volume and frequency of sampling. If any agents are to be given, specify the agent, dose, volume, frequency, and route of administration. If surgery is to be performed, include a brief technical description of the surgical procedure, including surgical approach, suture material, and suture pattern(s).
c. Drug usage. Will any sedatives, tranquilizers, anesthetics and/or analgesics be given for restraint and/or pain control during performance of the procedures? Do not discuss post-procedure pain control in this section
No
Yes List all anesthetics, sedatives, and/or analgesics that will be used to provide restraint and/or pain control during performance of the procedures described above. Complete 1, 2, and 3.
Procedure / Agent / Dose (mg/kg) / RouteIACUC Application Rodent Breeding Colony_7.10.2013#s 6
1. Monitoring during anesthesia. Describe methods used to monitor the state of anesthesia and general well-being of the animal during anesthesia of each of the procedures (i.e., reflexes, respiratory rate, body temperature, blood pressure, oxygen saturation, heart rate, EKG, etc.)
2. Intra-procedural support: Describe any support/care that will be provided to animals during anesthesia for each of the procedures (i.e., mechanical ventilation, IV fluids, heat support, etc.)
3. Post-anesthetic monitoring. Select one.
I will ensure that all sedated/anesthetized animals will be continuously monitored until they regain sternal recumbency and are capable of holding their heads up.
Not applicable, all sedated/anesthetized animals are euthanized before regaining consciousness.
d. Post-procedure pain management. Will analgesics be used to prevent pain, discomfort, or distress after any of the procedures? Administration of analgesics prophylactically is based upon the premise that where pain is concerned, the animals should usually be given the benefit of the doubt. All Protocols with major survival surgery require the use of prophylactic analgesics.
No Provide reason for not using analgesics.
Painful procedures are not proposed.
No survival procedures are being proposed
Pain, discomfort, or distress is expected but will not be treated.
Provide strong scientific justification for withholding analgesic agents when their use is indicated:
Yes List all analgesics to be used.
Procedure / Agent / Dose (mg/kg) / Route / Frequency / DurationIACUC Application Rodent Breeding Colony_7.10.2013#s 6
e. Surgery. Are any of the proposed procedures a surgical procedure?
No
Yes See Policy for Surgery
I assure that I have read and will conduct the project in full accordance with the Policy for Surgery
Section VII- Potential Pain, Discomfort and/or Distress
1. Animal Pain/Distress Classification. Choose the highest pain level classification. A painful procedure is defined as any procedure that would reasonably be expected to cause more than slight or momentary pain or distress in a human being.