INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)987830 Nebraska Medical Center

Omaha, NE 68198-7830402/559-6046

Fax 402/559-3300IACUCORA@unmc.edu

IACUC APPLICATIONFOR 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?

YesNoFaculty 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.PHSNebraska State Grant Funds (LB506)NSFDepartmental/Internal FundsContract. 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.

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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.

_______________________________________ __________ Principal Investigator Signature Date

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.

Species                    

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 pendingApplication will be submitted for approval

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

Wild-caught

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Section III-OverviewInstructions: 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.

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

NoYesExplain 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.

NoYes

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:      

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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? NoYes

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 Animals1. 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.

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

Number of Animals Requested

Purchased1 (or received from

another institution)

Transferred2

(from another UNMC/UNO

approved IACUC

protocol)

Bred/Produced3

on this protocol (Addendum

required)

Wild CaughtTotal Number

of Animals Requested by

SpeciesSpecies

                                   

                                   

                                   

                                   

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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 Studies1. Field Studies. Will you be doing field studies? Refer to Policy for Field Studies

NoYes 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.

2. 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).

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.

Procedure Agent Dose (mg/kg)

Route Species

                                                                                                                                                 

a. 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.)      

b. 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.)      

c. Post-anesthetic monitoring. Select one.IACUC Application Research/Testing/Training_7.10.2013#s 5

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.

4. 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.a. Drug:       Dosage:      Route:       Frequency:      Duration:     

b. Justify the use of a paralytic:      

c. 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:     

5. 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 AgentDose

(mg/kg) Route Frequency Duration Species                                                                                  

                                                                                  

6. Surgery. Are any of the proposed procedures a surgical procedure?NoYes 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 Distress1. 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

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(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 sedativedrugs 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.

Tumor Development:       Phenotypic Alteration:       Surgical Procedure:      Nonsurgical Procedure:       Ionizing Radiation:       Induced Disease:       Spontaneous Disease:       Toxin Exposure:       Other:      

b. Search for alternatives to potentially painful procedures. The use of procedures potentially causing more than momentary pain or distress to an animal, even though the pain will be relieved by administration of proper drugs, requires investigators consider alternative procedures. A literature search for alternatives to the above listed potentially painful/distressful procedure was performed. The details of the search are:

Date (month/day/year) of search:      Years covered by the search from:       to:      Keywords used in the search. Ensure to use the listed conditions, procedures, and/or phenotypic attributes (checked in part a) and the word “alternatives” as keywords):     Databases searched (2 required):      

Did the literature search reveal less painful/distressful alternatives to the proposed procedures?

No No alternatives were foundYes But they cannot replace the procedures that are proposed for the following

reasons:      

c. Animal health consequences. Describe all clinical signs and symptoms that may present in the animals as a result of protocol procedures, surgeries, agents, disease processes, genetic alterations, etc. Include onset, duration and severity of signs/symptoms as applicable.      

3. Monitoring Parameters. Select parameters from the list below that will be used to detect pain, distress, or discomfort. Monitoring of five or more parameters is recommended.

Parameter Species:     

Species:     

Species:     

Species:     

Feces and urine output (may require individual housing)Body weight. State frequency of weight checks:     Behavioral changes (aggression, guarding, hiding)Not eating or drinking (may require individual housing)

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Hair coat (ruffled fur, lack of grooming, piloerection)Activity level (restlessness, pacing, reluctance to move)Facial expression (eyes dull, pinning of ears, eyelids partially or completely closed)Posture (tense, tucked-up, hunched up)Ambulation (stiff gait, lameness, loss of

mobility)Licking, biting, scratching at procedure/surgical siteSurgical site (infection, dehiscence)Tumors (size, necrosis, ulceration, infection)Other :     

4. Frequency/Duration of Monitoring. What is the frequency (specified times per day) and duration (number of days) over which monitoring of the animals will be performed by the investigators/technicians? Note: The IACUC expects that all animals will be monitored at appropriate intervals that are dictated by the nature of the protocol, as well as the degree of potential pain, the likely duration of the pain and possible complications. a. Frequency (specified times per day):      b. Duration (number of days):      

5. Management Plan: If signs of pain, distress and/or discomfort are detected, describe the management plan to relieve pain, distress and/or discomfort in the animals.

Animals will be immediately euthanized. Other. Describe:       Pain relief drugs will be given. Indicate the drugs to be given.

AgentDose

(mg/kg) Route Frequency Duration Species                                                                      

                                                                                                         

6. Premature Euthanasia/Humane Endpoints. Animals that are experiencing unrelieved pain or distress prior to the defined experimental endpoints as described in Section IV- Project Design must be humanely euthanized, unless doing so would interfere with, or compromise, the scientific goals of the experiment.

Will you follow the Policy for Criteria for Premature Euthanasia-Humane Endpoints? Yes All personnel will comply with the policy. No I am requesting an exception/s to the policy.

Indicate which of the criteria that you are requesting an exception for:     Provide scientific justification for the requested exception:     What supportive care will be given to minimize discomfort, distress, or pain?      State endpoint for euthanasia:     

Section VIII-Exceptions to the Regulations/Policies/SOPsExceptions require strong scientific justification and IACUC approval prior to implementation. Check all that apply andanswer all applicable sections.

1. Exceptions to Standard Animal Care. Special diet/diet additiveWater additiveAltered feeding scheduleFood and/or water regulation. Refer to Policy for Food and/or Fluid Regulation. Additional information may be

required upon review. Food and/or water on cage floor

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Temperature extremesModified light cycleModified cagingWire bottom/metabolic cages. Please also complete Question 6. Social Housing Exception.Other Specify:     

a. Provide a complete description of all non-standard practices or procedures:     

b. State the frequency and duration of these practices or procedures:     

c. Justify the use of these non-standard practices or procedures:     

2. Physical Restraints. Physical restraint is the use of manual or mechanical means to limit some or all of an animal’s normal movement for the purpose of examination, collection of samples, drug administration, therapy, or experimental manipulation. Physical restraint procedures should be used on awake animals only after alternative procedures have been considered and found to be inadequate. If restraint is necessary, the device must provide the animal with the greatest opportunity to assume its normal postural adjustments, and the duration of restraint must be minimized. Refer to Policy for Physical Restraint

a. Provide a description of the restraint(s):      

b. Justify the need for restraint:      

c. What alternatives to restraint have been considered? Why are these alternatives inadequate?:      

d. State the frequency and duration of the restraint period(s):      

e. Describe steps to be taken to condition the animals to the restraining device and assure the comfort and well being of the animals.      

3. Non-Pharmaceutical Grade Agents. A pharmaceutical grade compound is a drug, biologic, or reagent that is approved by the Food and Drug Administration (FDA) or for which a chemical purity standard has been established by the United States Pharmacopeia-National Formulary (USP-NF), or British Pharmacopeia (BP). The use of pharmaceutical grade chemicals and other substances ensure that toxic or unwanted side effects are not introduced into studies conducted with animals. Investigators are expected to use pharmaceutical-grade agents whenever they are available, even in acute procedures. Non-pharmaceutical grade agents should only be used after specific review and approval by the IACUC for reasons such as scientific necessity or non-availability of an acceptable veterinary or human pharmaceutical grade product. Cost savings alone are not adequate justification for using non-pharmaceutical grade agents in animals. Refer to Policy for Non-Pharmaceutical Grade Compounds

a. List the agents to be used:      

b. Justify the need for use:      

c. Provide a detailed description of the methods used to ensure sterility of the drug:      

4. Multiple Major Survival Surgery A major survival surgery is any surgical intervention that penetrates and exposes a body cavity or any procedure which produces permanent impairment of physical or physiological functions. Multiple major survival surgeries on a single animal are discouraged but may be permitted if they are included in and essential components of a single research protocol and scientifically justified by the Investigator and approved by the IACUC. Cost savings alone is not adequate justification. Refer to Policy for Multiple Major Survival Surgery

a. List all major survival surgical procedures that may be performed on a single animal:      

b. Define the overall timeline of the procedures (i.e., how much time elapses between the survival surgeries):      

c. Provide a scientific justification for performing more than one major survival surgery on a single animal:      

5. Expired Drugs or Medical Materials. Most drugs or medical materials are imprinted with an expiration date, beyond which the manufacturer does not guarantee the safety or stability of the item. Use of expired drugs or materials without justification is considered inadequate veterinary care under Federal Regulations. Refer to Policy for Expired Drugs or Medical Materials

List/describe expired drug/medical material to be used List/describe intended use of each item

           

           

           

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a. Provide justification for the use of expired drugs or medical materials.      

b. Describe how proper sterility will be assured.      

c. Identify the building and room number where the expired items will be stored.      

6. Social Housing Exception-Social housing is considered the default method of housing unless otherwise justified based on social incompatibility resulting from inappropriate behavior, veterinary concerns regarding animal well-being, or scientific necessity approved by the IACUC. Commonly used laboratory animals regarded as potentially social species include the following: NHPs, Dogs, Sheep, Pigs, Rabbits (excluding adult males), Rodents (excluding adult male mice and female hamsters), Avian species, and Aquatic species. If a social housing exception is needed, provide the following. Refer to Policy for Social Housing

a. State which group/s of animals will not be socially housed:      

b. State the frequency and duration of non-social housing:      

c. Provide justification for non-social housing:      

7. Non-USDA Covered Species-Holding animals outside centralized animal facility for longer than 24 hours. Refer to Policy for Holding Animals Outside Centralized Facility

a. Identify the building and room number:      

b. State the length of time that the animals will be held outside the centralized animal facility:      

c. Provide justification for such proposed housing:      

8. USDA Covered Species-Holding animal outside centralized animal facility for longer than 12 hours. Refer to Policy for Holding Animals Outside Centralized Facility

a. Identify the building and room number:      

b. State the length of time that the animals will be held outside the centralized animal facility:      

c. Provide justification for such proposed housing:      

9. NHP-Exception to the NHP Behavior Management Program. Please consult the Attending Veterinarian for specific program information.

a. Provide a complete description of all requested exceptions:      

b. State the frequency and duration of these exceptions:      

c. Provide justification for the exceptions:      

10. Canine-Exception to the Canine Exercise Program. Please consult the Attending Veterinarian for specific program information.

a. Provide a complete description of all requested exceptions:     

b. State the frequency and duration of these exceptions:     

c. Provide justification for the exceptions:     

Section IX-Disposition/Euthanasia of Animals1. Final Disposition. What is the final disposition of live animals? Select all that apply.

Final DispositionSpecies:

     Species:

     Species:

     Species:

     

Animals will be euthanized according to planned project design.

Transferred to another protocol. Protocol #:     Released back into the fieldTransferred to another institution.Institution:     

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Other:     

2. Method/s of Euthanasia. Indicate the method of euthanasia. A method of euthanasia, regardless of the planned final disposition, must be identified in the event an animal needs to be euthanized to alleviate animal pain, discomfort, or distress. The method of euthanasia should be based upon the species, size of the animal, and its ability to quickly and painlessly produce a loss of consciousness and death. All methods of euthanasia must comply with current AVMA guidelines. Refer to Policy for Euthanasia

Species Method

           

           

           

           

           

3. Method to Ensure Death. What method will be used to ensure that euthanized animals are dead? State species and select all that apply.

MethodSpecies:

     Species:

     Species:

     Species:

     

Not-applicable-physical method already selected as method of euthanasia

Bilateral thoracotomy

Decapitation

Cervical dislocation

Exsanguination

Other:     

Other:     

Section X-Hazardous MaterialCheck all of the following hazards that will be used on this protocol. Refer to Policy for Hazard Management

Animal Biological Materials.Includes animal cell lines or other biological materials (serum, antibody preparations, etc.).Cell line(s):     Other biological material:     Species(s):     Source:     

Human Cell Lines. Includes primary or untested human cell lines. Cell line(s):     Source(s):     IRB Protocol Number:     IBC Protocol Number:     Have these cells been passaged through rodents?

NoYes

Infectious Agents, Viral Vectors, Recombinant DNA, Bacteria or Biological Toxins. Specify agent/ vector/ toxin:      Please provide a brief description of use:      IBC Protocol Number:      

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Will animals that have been exposed to any of the listed hazards be transported to any areas outside the centralized animal facility? (e.g., MRI, CT, lab, etc.)

No Yes Please address Section XI-Site of Study

Radioisotopes. Specify isotope(s) or radiation emitting equipment:     Will animals that have been exposed to radioisotopes be transported to any areas outside the centralized animal facility? (e.g., MRI, CT, lab, etc.)

No Yes Please address Section XI-Site of Study

Carcinogens/Toxic Chemicals. Specify chemical or drug:      Provide web link to MSDS:      Will animals that have been exposed to carcinogens/toxic chemicals be transported to any areas outside the centralized animal facility? (e.g., MRI, CT, lab, etc.)

No Yes Please address Section XI-Site of Study

Chemotherapy Agents. Specify agent/ drug:      

Section XI-Site of Study1. Procedure Location. Will any procedures on animals be performed outside the centralized animal facility?

No All animal procedures will be performed inside the centralized animal facility. Comparative Medicine will be contacted for arrangements for housing and procedure room assignments.

Yes Provide the procedure, building and room #. These sites must be approved in advance by the IACUC and are subject to inspection by the IACUC. If greater than 24 hours for non-USDA covered species or 12 hours for USDA covered species, complete Section VIII.7 or 8, as applicable.

Procedure Building Room #                                                   

2. Patient Care Areas. Will any procedures utilize UNMC/Nebraska Medical Center patient care areas? Refer to Policy for Animal Use in Public/Patient Care Areas

NoYes Submit Form - Proposal to Use Animals in Patient Care Areas at UNMC/TNMC to the CM

Safety/Compliance Coordinator. Approval of this form must be completed prior to animal use in patient care areas.

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Section XII-Personnel Qualifications Complete parts 1-4 for each individual covered in the IACUC application. The IACUC must ensure that personnel

conducting procedures on animals are appropriately qualified and trained in those procedures OR that an appropriate training plan is proposed.

Refer to “Requirements for Animal/Animal Facility Access” for instructions.

1. Personnel InformationName:Role: X one of the following.

PI: Secondary Investigator:Technician/Technologist: Student:Postdoctoral Associate: Research Associate:Faculty Advisor:

Phone: Email:

2. Education Institution and Location Degree Year Field of Study

3. Current Career Skills and Protocol Specific Responsibilities Current Skills - Check all current career skills under the species they been performed on. Protocol Responsibilities - Check the procedures you will be responsible for on this protocol under the species they will

be performed on. NOTE: Responsibilities that you will need to be trained in must be addressed in Part 4. For other species please type the names in the extra column(s).

Current Skills Protocol Responsibilities

PROCEDURES

Mic

e

Rat

s

Ham

ster

s

Rab

bits

Swin

e

NH

P

Mic

e

Rat

s

Ham

ster

s

Rab

bits

Swin

e

NH

PRoutine Care

Handling & RestraintInjections:

IV

IM

SC

IP

ICBlood Collection:

Tail vein

Jugular vein

Leg veins

Maxillary vein

Saphenous vein

Ant. vena cava

Orbital sinus

Cardiac puncture

Cut downs

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Surgeries (List):

Procedures (List):

Anesthesia:

Inhalant

Injectable

Aseptic technique

Intra-operative Monitoring

Post Procedural Monitoring

Breeding Colony ManagementIdentification:

Ear punch

Ear tag

Tattoo

Toe clipping

GenotypingEuthanasia:

CO2

Inhalation

Injectable

Decapitation

Cervical dislocationOther:

4. Training to be Provided For the protocol responsibilities that you need to be trained in, please complete the following: Note: Experienced

personnel that will provide training must be listed on this protocol.Species Procedure Training Technique (i.e, reading, observation, performed

with supervision)Person Providing

Training

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5. PI Assurance. Submission of this form indicates assurance by the PI that the following will be adhered to:1. All listed study personnel that are to be trained will be supervised by qualified individual(s) until such time that the

individual is qualified to work independently.2. Training records on this individual will be kept on file and are subject to periodic and unannounced inspections by the

IACUC, CM or UNO animal care staff, the Protocol Assessment Liaison (PAL), and other regulatory and accreditation agencies as necessary.

*To continue with additional personnel please copy and paste the entire form at the beginning of a new page.

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