UTC-IACUC PROTOCOL FORM

(FOR USE OF LIVE VERTEBRATE ANIMALS)

Submit the electronic version of the protocol to:

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:
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Telephone Numbers:

Office: / Cell: / E-Mail:
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Alternate for animal emergency or study-related action/communication with Authority to act in the Investigator’s absence:
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Alternate’s Telephone Numbers:

Office: / Cell: / E-Mail:
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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.)
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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

Published 09/06/2017

  1. GENERAL INFORMATION
  1. 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.)
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☐ 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:
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  1. Name and address of veterinarian responsible for clinical care:
  1. Funding Source for this protocol(internal-external grants and other sources):
  1. 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 summarymust 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.

  1. Flow Chart

Attach as a separate documenta flow chart or bulleted list that depicts the sequence of all animal procedures or manipulations (step by step) to be performed in this protocol.

  1. ANIMAL WELFARE
  1. 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.

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  1. Rationale

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

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  1. 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, “dummymodels were worked on and that the students are prepared to progress to live animals.)

If yes, please justify.

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  1. 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:

Please Note: Google ScholarIS 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.

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 / Click here to enter text.
Years covered by search (YY – YY) / Click here to enter text.
Search strategy (must show how keywords were combined) / Click here to enter text.
Other sources consulted. Provide individuals’ name, qualifications, date and summarize content / Click here to enter text.

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:

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

If not, please explain?

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

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  1. 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.

Health Assessment

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

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What are the anticipated health changes?

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What methods will be used to monitor health changes?

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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:

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  1. 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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  1. ANIMAL DESCRIPTION, HOUSING AND USE LOCATION(S)
  1. 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.

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  1. 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.

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  1. 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 #:
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☐ / Other. Please describe:
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  1. Are there any special requirements for housing/husbandry? ☐YES ☐NO

If “YES”, please complete:

☐ / Sterile Cages
☐ / Wire Bottom Cages*
☐ / Individually Housed*
☐ / Other. Please describe:
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*Please provide scientific justification for use of this type of housing/husbandry:

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  1. 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:

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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

  1. 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)
☐ / Other. Please describe:
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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.

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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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:

  1. 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.
  1. 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: 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):
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☐ / Anesthetic overdose
Drug:
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Dose:
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Route:
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☐ / Blunt Force Trauma. Justification:
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☐ / Cervical Dislocation (CD) under anesthesia or tranquilization
☐ / Conscious Cervical Dislocation. Justification:
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☐ / Conscious Decapitation. Justification:
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☐ / Decapitation under anesthesia or tranquilization
☐ / Exsanguination following anesthesia, stunning, captive bolt or CO2
Is Perfusion involved?
☐ / NO
☐ / YES. Please provide details:
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☐ / Slaughter (covered under the Humane Slaughter of Livestock, 9 CFR, Part 313)
☐ / Other. Specify:
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B. BEHAVIORAL STUDIES

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

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  1. Intensity and duration of stimulus:

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  1. Frequency of tests:

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  1. Length of time in test apparatus:

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  1. 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:

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  1. Study Site(s)

General Location:

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  1. Describe methods employed to prevent potential disease transmission between individual animals encountered in this activity (Use of disposable gloves; disinfect gloves between animals):

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  1. Describe methods employed to prevent potential disease transmission across multiple sites in this activity (Use of disposable gloves; disinfect gloves between animals):

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  1. Capture with mechanical devices
  1. Type/description of capture device/method:

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  1. Frequency of checking capture device:

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  1. Maximum time animal will be in capture device:

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

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  1. Methods to avoid non-target species capture:

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  1. Expected injury and/or mortality rates:

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

If no explain:

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

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

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  1. Capture with chemical immobilization.
  1. Type of dart or device to administer drugs:

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  1. Method of dart propulsion:

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

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  1. 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.

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  1. Marking/Telemetry Procedures
  1. Describe marking procedures to be used:

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  1. If a telemetry package is to be attached, describe:
  1. Weight of the total package

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  1. Type of antenna (including length)

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  1. Method of attachment

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

If yes, explain how:

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  1. Release of animals other than at capture site (for non-survival collection please see #9)
  1. Where will captured animals be released?

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

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