UTC-IACUC PROTOCOL FORM (FOR USE OF LIVE VERTEBRATE ANIMALS)

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UTC-IACUC PROTOCOL FORM

(FOR USE OF LIVE VERTEBRATE ANIMALS)

Submit the electronic version of the protocol to: [email protected]

Animals may not be procured and research involving animals may not begin until the PI is notified in

writing that the protocol has been approved by the IACUC.

Principal Investigator/Instructor(s): Department: Click here to enter text. Click here to enter text.

Telephone Numbers:

Office: Cell: E-Mail: Click here to enter text. Click here to enter text. Click here to enter text.

Alternate for animal emergency or study-related action/communication with Authority to act in the

Investigator’s absence: Click here to enter text.

Alternate’s Telephone Numbers:

Office: Cell: E-Mail: Click here to enter text. Click here to enter text. Click here to enter text.

Title of Project /Course: (If external funding source is listed in section B of this protocol, title of this

protocol should match the title of application to the sponsor.) Click or tap here to enter text.

☐ I have read and agree to follow the IACUC Bylaws and SOPs #1- 6 (www.utc.edu/research-integrity/institutional-animal-

care-use-committee/policy-and-guidelines.php)

Your signature as P.I., Co-investigator, or Department Head on this application verifies that: (1) the information herein is true and

correct and that you are familiar with and will comply with the legal standards of animal care and use established under federal and

state laws and policies as well as university policies; (2) the proposal has received approval for scientific and/or educational merit by

peer review; and (3) the activities do not unnecessarily duplicate previous experiments.

Signature of PI/Instructor Date

Signature of Co-PI/Instructor(s) Date

Signature of Department Head (Dean/Associate Dean if Dept. Head is PI) Date

mailto:[email protected]

http://www.utc.edu/research-integrity/institutional-animal-care-use-committee/policy-and-guidelines.php

http://www.utc.edu/research-integrity/institutional-animal-care-use-committee/policy-and-guidelines.php

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1. GENERAL INFORMATION

A. This protocol:

Anticipated Start Date: Click here to enter text. End Date: Click here to enter text.

These dates must be later than the IACUC meetings. Best practice is to place your start date at least two weeks

following the third Tuesday of each month.

☐ New ☐ 3-Year Rewrite (Please provide a brief description of research progress to date.)

Click here to enter text.

☐ Holding ☐ Breeding ☐ Research ☐ Teaching (Course Name: Click here to enter text.)

☐ Collaboration between UTC and any another institution/agency/outside entity. A memorandum of

understanding (MOU) must be submitted prior to IACUC protocol review and commencement of the work

or movement of animals. If working with another institution, please provide the context of the collaboration

(i.e., funding, personnel involvement, animals). Click or tap here to enter text.

☐ Part of a grant or other contractual obligation:

Please provide grant/contract information Click here to enter text.

B. Name and address of veterinarian responsible for clinical care:


C. Funding Source for this protocol (internal-external grants and other sources):


D. Non-Technical Summary

A complete non-technical summary is required for conformance with Public Health Service Policy. Non-technical

summary must be submitted as an attachment and should not exceed two (2) pages. Non-technical summary must be

written to ensure comprehension by non-scientists on an 8th grade level. It must contain the following:

1) Objectives of the research or teaching activity;

2) Species and number of animals;

3) Methods used to reduce any experimental stress or discomfort

4) Schedule of the course or the study procedures performed on animals during each phase

5) Benefits, outcome and results expected in non-technical terms.

E. Flow Chart

Attach as a separate document a flow chart or bulleted list that depicts the sequence of all animal procedures or

manipulations (step by step) to be performed in this protocol.

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2. ANIMAL WELFARE

A. Benefit

Describe the potential scientific benefit of the proposed study. Be convincing as to why this work is

important for advancement of knowledge, improving human or animal health, or for the good of society.


B. Rationale

Please explain your rationale for using live animals and why the proposed species is/are the most appropriate

for this study.


C. Duplication

The Animal Welfare Act and USDA Animal Care Policy #12 require PIs to assure the IACUC that you have

considered whether or not your proposed work unnecessarily duplicates existing knowledge.

Does the proposed activity unnecessarily duplicate any previous work? ☐ YES ☐ NO

(Note: Teaching activities are duplicative but instruction of new students warrants repeat of these activities. It is necessary that a robust

alternatives search be performed for ethical category “D” teaching protocols and very briefly include the pertinent alternatives information

being done prior to live animal use. It should state, for example, that videos were watched, simulation labs were done, “dummy models were

worked on and that the students are prepared to progress to live animals.)

If yes, please justify.


D. Search for Alternatives to Painful/Distressful Procedures

A painful procedure in an animal is defined as any procedure that would be reasonably expected to

cause more than slight or momentary pain and/or distress in a human. The UTC-IACUC is responsible

for ensuring that investigators have appropriately considered alternatives.

Does this study/activity include painful or distressful procedures? ☐ YES ☐ NO

If no, skip to Section E. If yes, the minimal written narrative should include:

a. The databases searched or other sources consulted,

b. The date of the search and the years covered by the search,

c. Key words and/or search strategy used,

d. A narrative written in such a way that the IACUC can readily assess whether the search topics were

appropriate and whether the search was sufficiently thorough.


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For information on conducting an alternatives search and appropriate databases, please visit:

http://www.nal.usda.gov/awic/alternatives

Please Note: Google Scholar IS NOT A RESEARCH DATABASE AND CANNOT BE USED AS A RESOURCE

FOR ALTERNATIVE SEARCHES.

Literature searches for alternatives should be performed specifically for those proposed procedures that may cause

more than slight or momentary pain and/or distress.

Alternatives or alternative methods are generally regarded as those that incorporate some aspect of replacement,

reduction, or refinement of animal use in pursuit of the minimization of animal pain and distress consistent with the

goals of the research. To satisfy this requirement, the USDA believes that database searches remain the most

effective and efficient method for demonstrating compliance with the requirement to consider alternatives to

more than momentary painful / distressful procedures.

For each painful procedure, were alternatives identified (to replace, refine, and reduce)?

Please address appropriate answer(s) below if yes or no. ☐ YES ☐ NO

If “Yes”, please describe:


Will these alternatives be incorporated into your proposed work? ☐ YES ☐ NO

If not, please explain?


If “No”, please provide a written narrative about your search results including references:


E. Monitoring Health and Well-being

Animals should be monitored at regular intervals for health and well-being. The frequency of this monitoring by

personnel listed on the protocol is variable and based on the protocol’s procedures.

Database Information

Name of Database searched * Click here to enter text.

Date of search (must be within 6 months of

protocol submission) MM/DD/YY


Years covered by search (YY – YY) Click here to enter text.

Search strategy (must show how keywords were

combined)


Other sources consulted. Provide individuals’

name, qualifications, date and summarize content


http://www.nal.usda.gov/awic/alternatives

https://scholar.google.com/

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Health Assessment

How often and by whom will the clinical condition of animals be monitored?


What are the anticipated health changes?


What methods will be used to monitor health changes?


The individuals responsible for monitoring the health and well-being of your protocol animals are: (provide

contact information including cell phone number and email address:


F. Removal from study

If necessary, what criteria will be used to remove an animal from use prior to the planned conclusion of the study?

Include what “remove from study” means. For example, will animal no longer participate in the study, but be returned

to colony/herd or will animal be euthanized immediately? For each criterion, define a specified duration or

endpoint. For example, “animals will be removed from the study if diarrhea is observed for greater than 24 hours”.

Some studies would have very limited removal criteria if they are short term – possibly if the animal is fractious or

have a low blood count when pre-study blood work is performed. Other criteria would be directly related to the

specific study/activity procedures.


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3. ANIMAL DESCRIPTION, HOUSING AND USE LOCATION(S)

A. Description of Animals

Protocols are approved for three years; therefore, the number of animals requested should be the total

number of animals needed for the entire project over the three-year period.

Species: Common name Species: Scientific name Source Sex Total # Animals

Requested

Maximum

# per day

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List strains of rodents whose use is anticipated. Exact numbers of each strain is not warranted. This

information may be beneficial for husbandry purposes.


B. Animal Number Justification. Provide an explanation of how animal numbers were derived and justify

that need. A table may help clarify different experimental groups or studies and the specific numbers needed

for each.


C. Animal Housing and Use Areas

Please check your preferred housing location. Animal housing space is assigned by the IACUC. Every reasonable

attempt will be made to accommodate investigator requests for preferred housing locations.

☐ Davenport Hall

☐ Holt Hall

☐ UTC-IACUC Approved Satellite Facility

List Bldg./Room #:


☐ Other. Please describe:


D. Are there any special requirements for housing/husbandry? ☐ YES ☐ NO

If “YES”, please complete:

☐ Sterile Cages

☐ Wire Bottom Cages*

☐ Individually Housed*



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*Please provide scientific justification for use of this type of housing/husbandry:


E. Will animals be removed from the animal housing location? ☐ YES ☐ NO

If yes, please answer the following:

1. Animals will be taken to (bldg/room number): Click here to enter text.

2. Animal manipulations that will be performed in the laboratory include:


3. Estimated total time period live animals will be kept in the laboratory: Click here to enter text. hours.

4. Will animals be returned to the animal housing facility? ☐ YES ☐ NO

F. Planned disposition of the animals after completion of the activity:

☐ Return to production/breeding unit/facility inventory

☐ Slaughter, (must conform to the Humane Slaughter of Livestock, 9 CFR, part 313)

☐ Returned to owner

☐ Transfer to another research project (if yes, project title and investigator)

☐ Sold

☐ Euthanized (Fill out section on Euthanasia)



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4. PERSONNEL

List all personnel involved in this protocol and provide training information. Include all investigators, student

employees, post-doctoral researchers, staff research associates and laboratory assistants. Personnel or groups of

personnel listed will be the only personnel approved to work under this protocol. Should new staff need to be added,

this must be done via an amendment, which must be approved before the new staff may begin working with the

animals.

1CITI Training information: Documentation that all personnel are appropriately trained in animal care and use is federally and

institutionally mandated. A general web-based training and certification program is required for all personnel. Further, more

specific training may be necessary depending on the species and procedures proposed. Please review the UTC IACUC website

for training requirements and resources under “Training” at: http://www.utc.edu/research-integrity/institutional-animal-care-use-

committee/training.php .

Name + Degree+ email

address

CITI completion date or

date of most recent

mandatory training1. This

must be completed prior to

working with animals.

Procedures this person will perform & relevant

experience/training

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MORE LINES AS NEEDED

http://www.utc.edu/research-integrity/institutional-animal-care-use-committee/training.php

http://www.utc.edu/research-integrity/institutional-animal-care-use-committee/training.php

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5. ANIMAL PROCEDURES

Please check all the listed procedures that apply to your protocol and fill out the appropriate sections.

☐ A. Euthanasia

☐ B. Behavioral studies.

☐ C. Animal field studies.

☐ D. Off-site captive animal studies.

☐ E. Anesthesia/analgesia.

☐ F. Surgical Procedures.

☐ G. Projects involving captive aquatic animals.

☐ H. Hazardous agent use (biological, radioactive, or chemical).

☐ I. Use of Recombinant Materials.

☐ J. Substance(s) collected from live animals (Blood*, or other body fluid withdrawal, tissue collection, tail clip*)

(Do not list collections post mortem)?

☐ K. Other manipulations not described above.

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A. EUTHANASIA

Information must be provided for all live animal activities, including non-terminal studies, where an animal may

experience a Humane Endpoint not related to the research. Methods of euthanasia must be acceptable by the most

recent Report of the AVMA Guidelines on Euthanasia, which can be found at the following web address:

https://www.avma.org/KB/Policies/Documents/euthanasia.pdf. Conscious physical methods must be scientifically

justified below. All agents used for the euthanasia of animals must be in-date and approved through IACUC.

☐ Euthanasia is part of the study design

OR

☐ Euthanasia is NOT part of the study design

Method of euthanasia:

☐ Anesthetic Barbiturate Overdose (An approved veterinary product):


☐ Anesthetic overdose

Drug:


Dose:


Route:


☐ Blunt Force Trauma. Justification:


☐ Cervical Dislocation (CD) under anesthesia or tranquilization

☐ Conscious Cervical Dislocation. Justification:


☐ Conscious Decapitation. Justification:


☐ Decapitation under anesthesia or tranquilization

☐ Exsanguination following anesthesia, stunning, captive bolt or CO2

Is Perfusion involved?

☐ NO

☐ YES. Please provide details:


☐ Slaughter (covered under the Humane Slaughter of Livestock, 9 CFR, Part 313)

☐ Other. Specify:


https://www.avma.org/KB/Policies/Documents/euthanasia.pdf

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B. BEHAVIORAL STUDIES

1. Describe animal methodology/test(s) to be used:


2. Intensity and duration of stimulus:


3. Frequency of tests:


4. Length of time in test apparatus:


5. Potential adverse events:


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C. ANIMAL FIELD STUDIES

1. List and include a copy of any permits required (e.g. Tennessee Wildlife Resources Agency, U.S. Fish and Wildlife

Service, Endangered Species)

Name and number:


2. Study Site(s)

General Location:


3. Describe methods employed to prevent potential disease transmission between individual animals encountered

in this activity (Use of disposable gloves; disinfect gloves between animals):


4. Describe methods employed to prevent potential disease transmission across multiple sites in this activity (Use

of disposable gloves; disinfect gloves between animals):


5. Capture with mechanical devices

a. Type/description of capture device/method:


b. Frequency of checking capture device:


c. Maximum time animal will be in capture device:


d. Methods to ensure well-being of animals in capture device:


e. Methods to avoid non-target species capture:


f. Expected injury and/or mortality rates:


g. Animal will be released at capture site after completion of procedures: ☐ YES ☐ NO

If no explain:

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h. Precautions used to minimize injury and/or mortality?


i. Describe method(s) used to sanitize capture devices between capture locations or groups of individuals:


6. Capture with chemical immobilization.

a. Type of dart or device to administer drugs:


b. Method of dart propulsion:


c. Precautions used to minimize injury and/or mortality:


d. If wild animals will be anesthetized and released to the wild, describe procedures for assuring that animals are

sufficiently recovered from anesthetic to be released. Consider that prey species may have to be monitored until

fully recovered to avoid predation.


7. Marking/Telemetry Procedures

a. Describe marking procedures to be used:


b. If a telemetry package is to be attached, describe:

1. Weight of the total package


2. Type of antenna (including length)


3. Method of attachment


4. Will marking/telemetry device be removed? ☐ YES ☐ NO

If yes, explain how:

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8. Release of animals other than at capture site (for non-survival collection please see #9)

a. Where will captured animals be released?


b. If the animals are transported indicate the method of transportation:


c. If the animals are to be housed, fill out Animal Housing and Use Location(s) section.


d. If release is not the general location of capture, justify.


9. Non-Survival Collection

a. Describe procedure(s) to be used:


b. Describe precautions that will be taken to prevent non-target mortalities:


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D. OFF-SITE CAPTIVE ANIMAL STUDIES

1. List and include a copy of any permits required (e.g. Tennessee Wildlife Resources Agency, U.S. Fish and Wildlife

Service, Endangered Species) as well as the required Memorandum of Agreement (MOA) between the

researcher, and the owner/operator of the sites involved (e.g. zoos, organizations, private entities, others)

Name and number:


2. Study Site(s)

General Location:


3. Describe methods employed to prevent potential disease transmission between individual animals encountered

in this activity (Use of disposable gloves; disinfect gloves between animals):


4. Describe methods employed to prevent potential disease transmission across multiple sites in this activity (Use

of disposable gloves; disinfect gloves between animals):


5. Describe responsibilities of the researchers and owner/operator of the sites:

a. Type/description of researcher responsibilities:


b. Type/description of owner/operator of the sites responsibilities:


c. Precautions used to minimize injury and/or mortality?


6. Capture/release of animals:

a. If animals are handled, who will and how will they be captured?


b. Precautions used to minimize injury and/or mortality:


a. How will they be reintroduced to their environment at release:


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E. ANESTHESIA/SEDATION/ANALGESIA

Adequate records describing anesthetic monitoring and recovery must be maintained and available in the animal’s medical

record. Animals must be monitored until awake and can maintain sternal recumbency.

Investigators are required to use pharmaceutical grade drugs and compounds whenever commercially available, even in

terminal procedures. All anesthetics and analgesics must be in-date, even for use in terminal procedures.

☐ For Clinical Trial Studies (mark if applicable), “The protocol will be determined on a patient by patient basis by the

duty anesthesiologist consistent with the standard of care for the veterinary profession using commercially available

products.”

Agent Concentration/

Dose (mg/kg) Volume and route Frequency

Pre-emptive analgesic Click here to enter text. Click here to enter

text.

Click here to enter

text.

Click here to

enter text.

Pre-anesthetic/sedation Click here to enter text. Click here to enter

text. Click here to enter

text. Click here to

enter text.

Anesthetic Click here to enter text. Click here to enter

text. Click here to enter

text. Click here to

enter text.

Post-procedural

analgesics*

Click here to enter text. Click here to enter

text.

Click here to enter

text.

Click here to

enter text.

Paralytics (need to justify

below in question h.)


text.

Click here to enter

text.

Click here to

enter text.

Other (supplementary

drugs or compounds, i.e.

Atropine)


text.

Click here to enter

text.

Click here to

enter text.

1. List each non-pharmaceutical drug, justifications for use, why pharmaceutical grade cannot be used (if applicable),

the preparation of the agent, labeling, and storage:


If post-operative analgesics are going to be given as needed, an IACUC approved procedure on recognizing pain

and distress must be followed.

2. Reason for administering agent(s):


3. For which procedures:


4. Method and frequency of monitoring anesthetic depth during the procedure, including when paralyzing drugs are

used:

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5. Methods of physiologic support during anesthesia and recovery:


6. Frequency of recovery monitoring:


7. Specifically what will be monitored:


8. Describe any behavioral or husbandry manipulations that will be used to alleviate pain, distress, and/or discomfort:


9. If using paralytic drugs, scientific justification is needed:




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F. SURGICAL PROCEDURES

• All survival surgical procedures must be done aseptically, regardless of species or location of surgery.

• Adequate records describing surgical procedures, anesthetic monitoring and postoperative care must be maintained

and available for the attending veterinarian and animal care staff.

1. Location (Room/Building) of surgery:


2. Type of surgery:

☐ Non-survival surgery: (animals euthanized without regaining consciousness).

☐ Major survival surgery: (major surgery penetrates and exposes a body cavity or produces substantial impairment of

physical or physiologic function).

☐ Minor survival surgery.

☐ Multiple major survival surgery.

If multiple major survival surgery, provide justification for multiple major survival surgical procedures:


3. Pre-op preparation of the animals:

a. Food restricted for Click here to enter text. hours.

b. Water restricted for Click here to enter text. hours.

4. Surgery techniques (check all that apply):

☐ Survival surgery or procedures requires at a minimum, the use of sterile instruments, surgeon washing hands

prior to donning sterile gloves, mask, approved operating area, removal of hair or feathers, skin prep with

disinfectant like betadine, and aseptic techniques during the surgery or procedure.

☐ Non-survival surgery requires at a minimum the surgical site should be clipped, surgeon wears gloves, the

instruments and surrounding area is clean and approved as an operating area.

5. Describe the following surgical procedures:

a. Skin incision size and location on the animal:


b. Describe surgery in detail (include size of implant if applicable):


c. Method of skin closure (include number of layers, type of wound closure, proposed suture type, size ranges):

i. Type:


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ii. Suture size/wound clips:


iii. Pattern:


6. Recovery from surgical manipulations:

a. Following recovery, what parameters will be monitored?


b. Person who will monitor the animals?


c. How frequently will animals be monitored?


d. How long post-operatively will animals be monitored:


e. Time post-operatively that sutures/staples will be removed, if applicable:


f. What long-term side-effects resulting from the surgical procedure are expected during the course of the study and

how will these be monitored?


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G. PROJECTS INVOLVING CAPTIVE AQUATIC ANIMALS

1. Water quality monitoring:

a. How is the water quality established/determined prior to introduction of animals?


b. How is the water filtered to remove nitrogenous/animal waste compounds?


c. How frequently and what parameters for the water quality are monitored?


2. Housing:

a. Briefly describe the system design and housing used (include type of water circulation, tank size):


b. Provide the approximate housing density:


c. Provide how often and how the housing will be sanitized:


d. What type of environmental enrichment is being provided in the tank/housing? (PVC pipe, plants, etc.). If none is

used, please justify:


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H. HAZARDOUS AGENT USE (BIOLOGICAL, RADIOACTIVE, OR CHEMICAL)

Will any of the following be used in the animals either in the Animal Care Facility or elsewhere?

☐ * Infectious Agents

☐ * Toxic Chemicals or Carcinogens

☐ **Radioisotope

☐ *** Legend (prescription) drugs and/or controlled substances (SEE BELOW)



If yes, list agent and describe all procedures necessary for personnel and animal safety including biohazardous

waste and carcass disposal and cage decontamination in the following chart:

* Biosafety must be addressed in the protocol.

** Radiation safety must be addressed in the protocol and radiation licensure is required.

Licensure Number: Click here to enter text.

*** Legend Drugs and Controlled Substances:

If you use Legend substances, do you have the appropriate licenses and legend and approval for the drugs you

will use in your project or class? ☐ YES ☐ NO

In Tennessee, it is not legal to divert drugs from clinical use to teaching and research use. You, or someone in

your group acting as an agent for the group, must have a license for each individual legend drug that you might

use in teaching or research. A legend drug is one where the label says “Federal Law restricts this drug to use by

or on the order of a licensed veterinarian” or “Federal Law prohibits dispensing without a prescription”. If the

drug is a controlled substance, you also need a license from the Drug Enforcement Administration for the

specific drugs that you may use. Obtaining and using such drugs for research will be reviewed.

Agent Concentration Route of

Administration

Duration of

Exposure

Post Exposure

Maintenance of

Animals

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I. USE OF RECOMBINANT MATERIALS

Recombinant nucleic acid molecules are those that are constructed outside living cells by joining natural or synthetic nucleic

acid segments to nucleic acid molecules that can replicate in a living cell, or molecules that result from the replication of

such. This includes generation and/or use of genetically-modified microorganisms, viruses, or cell lines; transgenic plants

or animals; and/or recombinant vaccines or therapeutic agents that are NOT licensed (commercially available) or otherwise

deregulated by a U.S. Federal authority (EPA, FDA, or USDA).

The use of recombinant DNA molecules in conjunction with animals must be declared by the PI in their IACUC protocol

for Biosafety evaluation and risk assessment. In most instances, the use of recombinant or synthetic nucleic acid molecules

in conjunction with animals will require approval by the Institutional Biosafety Committee (IBC) in order to ensure

compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

Please select the following recombinant materials to be used in this protocol and describe below:

☐ Purified recombinant/synthetic nucleic acid molecules

☐ Genetically-modified microorganisms (archaea, bacteria, fungi, protozoa)

☐ Genetically-modified viruses/viral vectors

☐ Genetically-modified cell lines (e.g. human cell xenografts)

☐ Purified recombinant products (e.g. proteins, hormones, etc.)

☐ Recombinant vaccines or other therapeutic agents

☐ Transgenic plants

☐ Transgenic animals that are created and/or used at UTC:

a. Describe approach or procedure to produce modification:


b. What gene(s) were intentionally modified:


c. If known, expected product over expressed / under expressed:


d. Describe any potentially debilitating phenotypes associated with this animal:


Briefly summarize the proposed recombinant materials:


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J. SUBSTANCE(S) COLLECTED FROM LIVE ANIMALS

Substance Collected*

Site of collection Method of

collection

Amount Collected Frequency of Collection(s)

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K. OTHER PROCEDURES NOT DESCRIBED ABOVE

Please describe in detail what will be done to animals (this response should provide the IACUC with a clear

understanding of procedure(s) to be performed on an animal or group of animals not covered in other sections.

1. Describe animal methodology/manipulation/test(s) to be performed:


2. Duration:


3. Frequency of tests:


