For Animal Research/Testing/Training

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 ANIMAL RESEARCH/TESTING/TRAINING

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. Type of Project. What is the primary purpose of this protocol? Check ONLY one.

Research/Testing- Proceed to question 7.

Training/Education

Identify the specific target population:

Assurance: I assure all students enrolled in this course will receive Occupational Health and Safety (OHS) clearance, as necessary, and will be provided with fundamental training in the humane care and use of laboratory animals, as applicable, i.e., current federal policies/regulations governing the care and use of laboratory animals, institutional policies and ethical principles governing animal care and use, research and testing methods that minimize animal pain and distress, non-animal alternatives, educational resources, species information, principles of anesthesia/pain monitoring, pre and postoperative care, AVMA recommendations regarding euthanasia, and IACUC and CM policies.

7.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.

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.

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______

Principal Investigator Signature Date

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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. The IACUC recommends submission of a separate protocol for each species to be utilized, when feasible.

2. Source of Animals. Select all that apply and provide requested information.

Approved commercial vendor. Vendor name:

Another institution. Institution name:

On campus breeding colony. Refer to Policy for Rodent Breeding Colonies

IACUC Breeding Colony Protocol already approved. IACUC protocol #:

Application has been submitted but approval is currently pending

Application will be submitted for approval

Animals will be bred on this protocol. Complete and attach Addendum to Experimental Application-Breeding Procedures.

Wild-caught

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. Project Overview. Provide a non-technical, lay language summary (250 words or less) of the proposed project that can be understood by non-scientists, community members, and IACUC members with varied research backgrounds. Discuss the potential value of the project with respect to human or animal health, the advancement of knowledge or the good of society. Identify the information gaps the project is intended to fill. The relative value of the study is a particularly important consideration in potentially painful experiments where it is imperative that the potential benefits of the research clearly outweigh any pain, discomfort or distress experienced by the animal.

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2.Duplication. Does the proposed project duplicate previous projects? Research involving animals must not unnecessarily duplicate previous projects conducted at UNMC/UNO or elsewhere.

No

Yes

Explain why the duplication is scientifically necessary:

3. Animal Use Justification. The justification for using live vertebrate animals rather than alternative non-animal models (e.g. mathematical or computer) or in-vitro models (e.g. tissue culture) to achieve the project goal is: (check all that apply).

The complexity of the processes being studied cannot be duplicated or modeled in simpler systems.

There is not enough information known about the processes being studied to design nonliving models.

Other

Explain:

4. Species Justification. This species was selected for the project because of the following attributes (check all that apply).

A large database exists allowing comparisons with previous data.

The anatomy or physiology is uniquely suited to the project proposed.

This is the lowest sentient species that is suitable for the proposed project.

Other

Explain:

5. 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.

6. 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-Project Design and Justification of Number of Animals

1. Research/Course Design. The design should allow the IACUC reviewer to understand exactly what will be done to all the animals from entry into the study to the endpoint of the study. Provide the following:

• Define the groups and number of animals per group.
• For each group, list the anticipated sequence of all procedures to be performed on live animals by providing a timeline, diagram or flowchart.
• Define the project endpoint (when the scientific aims and objectives have been reached) for each group of animals (i.e. what determines when the project is complete and the animals are to be euthanized and/or other final disposition).
• DO NOT include detailed descriptions of procedures, surgeries and in-vitro studies.

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2. Number of Animals Requested. Complete the following table indicating the numbers of animals that will be purchased, transferred, wild caught, and/or bred on campus. Include only a grand total of animals requested per your research/course design. Ensure that the total number of animals as outlined in the research/course design section is equal to total number of animals requested.

1Number Purchased. This includes animals purchased from an approved commercial vendor and/or animals received from another institution. All animal orders must be coordinated through Comparative Medicine regardless of source.

2Number Transferred. This includes animals that are transferred from a different IACUC approved protocol including Breeding Colony Protocols. Include in this column the number that will be transferred and the approved IACUC protocol number. If you are submitting a Breeding Colony Protocol in conjunction with this application, fill in the number of animals to be transferred and write “pending” in the source column. The numbers proposed and justified in this application should only apply to the experimental animals.

3Number Bred/Produced. If you need to breed animals for use on this protocol as part of the experimental design, complete the chart and list only the number of animals (i.e. pregnant females, neonates, and/or pups) produced that will be subjected to experimental manipulations. Complete and attach Addendum to Experimental Application-Breeding Procedures

3. Number Justification. In accordance with the principle of animal reduction, the minimum number of animals required to obtain valid results must be used. Whenever possible, the number of animals should be statistically justified. The justification for determination of number of animals needed per group is based on the following (select all that apply): DO NOT include total number of animals needed in this section.

A statistical estimate of the number required to achieve statistical significance.

Provide the statistical power analysis:

The estimated minimum number necessary to achieve the goals of the project in the absence of a statistical estimate.

Explain:

The number necessary to obtain sufficient tissue or other material for testing or analysis.

Explain:

The number required to provide sufficient technical training or practice for the number of trainees expected.

Explain:

Section V-Field Studies

1. Field Studies. Will you be doing field studies? Refer to Policy for Field Studies

No

Yes Complete and attach Addendum to Application-Field Studies.

Section VI- Procedures

1. 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.

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1. 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).

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3. 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 section a, b, and c.

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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.

1. Paralyzing Agents. Will neuromuscular blocking agents (paralytics) be used at any time during the procedure?

No

Yes Federal regulations prohibit the use of paralytics for procedures unless the animal is in an appropriate plane of

anesthesia. Complete a, b, and c.

1. Drug: Dosage: Route: Frequency: Duration:

1. Justify the use of a paralytic:

1. Describe the proposed anesthetic monitoring procedures in paralyzed animals (i.e., heart rate, blood pressure) that will be used to ensure an adequate state of anesthesia:

1. 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.

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1. 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.

(C) The protocol involves no pain, discomfort, distress or only momentary slight pain, discomfort, or distress that does not require the use of pain-relieving drugs. Examples include:

• Injections

• Blood sampling from peripheral vessels
• Post mortem collection of tissues
• Behavioral observations
• Behavioral testing without pain, discomfort, or distress

(D) The protocol involves potential pain or distress for which appropriate anesthetic, analgesic, or sedative drugs will be used and/ or maintenance of animals with a disease/functional deficit.

Choose the appropriate sub-category:

(D1) Minor short-term potential pain, discomfort, or distress. Examples include:

• Terminal surgery
• Minor survival surgery (e.g., biopsy, implantation of chronic catheters)
• Retro-orbital blood collection
• Short term (<60 min) physical restraint of awake animals
• Induction of minor behavioral discomfort or distress

(D2) Moderate potential pain, discomfort or distress and/or disease/functional deficit. Examples include:

• Induction of disease or functional deficit (e.g., diabetes, glaucoma, heart failure)
• Tumor induction
• Major survival surgery (e.g., laparotomy, thoracotomy, orthopedic surgery)
• Long term (>60 min) physical restraint of awake animals

(E) The protocol involves pain or distress for which the use of appropriate anesthetic, analgesic or sedative

drugs will not be used. Examples include:

• Application of a noxious stimuli that the animal cannot avoid/escape
• Toxicity testing, carcinogenesis testing, infectious disease testing, etc that prohibits medical treatment of clinical symptoms
• Death as endpoint

Justification. Justify why appropriate anesthetics, analgesics or sedatives WILL NOT BE USED:

Assurance. I assure that pain/distress relief will be withheld for the shortest period of time necessary.

2. Identification/Search of Potentially Painful, Distressful Procedure/Conditions. If you selected Pain Classification D or E above, provide an answer to a, b, and c. If you selected Pain Classification C, proceed to question 3.

a. Identify potentially painful, distressful procedures/conditions. Check and list all specific procedures, surgeries, conditions, and/or phenotypic attributes that may result in animals experiencing more than momentary slight pain, discomfort, or distress.