Submit 1 electronic Word version of the protocol to: . To advance from one field to another press the tab key. To place a check in a box, double-click with your mouse to the left of the box. Please use a font of your choice other than Times Roman which makes reading your specific protocol information easier. Please MINIMIZE formatting changes to our form.

Proposal Title: Click here to enter text.

Principal Investigator (PI):Click here to enter text.
Department:Click here to enter text.
Phone Numbers:
Office:Click here to enter text. Cell: Click here to enter text.
e-mail:Click here to enter text.
Corresponding Contact:
(in addition to PI - optional)
Click here to enter text. / Emergency Contact: (other than PI, with authority to act in the absence of PI):
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Department:Click here to enter text. / Department:Click here to enter text.
Phone Numbers:
Office:Click here to enter text. Cell: Click here to enter text. / Phone Numbers:
Office: Click here to enter text. Cell: Click here to enter text.
e-mail:Click here to enter text. / e-mail:Click here to enter text.

Principal Investigator Responsibilities

In the context of IACUC protocols and compliant animal use, someone may be considered as the PI if they have responsibility and authority for the research or teaching activities being conducted, and for the staff and students participating in the work. This level of control and responsibility typically falls to a faculty member that reports directly to a Department or Unit Head. There are occasional exceptions when someone other than a faculty member has the required authority. If you have any questions, please contact the IACUC Office at or 865-974-3631.

  • The Principal Investigator (PI) agrees to comply with all federal and state laws, regulations and guidelines and all institutional policies and procedures concerning the care and use of animals in research, teaching and extension.
  • The PI affirms that this proposal does not unnecessarily duplicate previous research.
  • The PI is responsible for obtaining IACUC approval in writing before making any changes in project procedures, personnel, locations, numbers or species of animals to be used.
  • The PI is responsible for ensuring that the description of animal use in this protocol is the same as that described in intramural or extramural proposals approved for funding.
  • If the PI leaves the University or leaves campus for an extended period, a new PI must be approved by the IACUC before the departure date or the protocol will be terminated.

I have read and accept these responsibilities.

Brief instructions: Please complete pages 1-11. On page 12, check the procedures used in your study and complete the appropriate appendices. You may delete unused appendices. Placing your cursor over the box and clicking twice will place the “X” inside the box.

  1. GENERAL INFORMATION
  1. This protocol:

☐New ☐3-Year Rewrite (Please provide a brief description of research progress to date.
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☐ Holding ☐Breeding ☐Research ☐Teaching
Course/CE Name:
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☐Collaboration between UT-K and another institution. A memorandum of understanding (MOU) must be submitted prior to commencement of the work or movement of animals. If working with another institution, please provide the context of the collaboration (i.e., funding, personnel animals)
  1. Funding Source for this protocol:

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For NIH proposals, the Vertebrate Animals and Research Strategy sections of your grant must be attached or submitted as a separate document. The reviewer will be comparing:

1)Species

2)Animal Numbers

3)Procedures

  1. Non-Technical Summary

Briefly describe in lay terms, nonmedical, nontechnical language (aim for a high school senior 12th grade reading level, as not all IACUC members have scientific background) the purpose of the proposed research or teaching activity. Spell out all acronyms at first occurrence.

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  1. Flow Chart

Provide 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.

Note: For clinical trials, only list procedures that exceed the standard of care provided to UTK-CVM clinical patients. Specifics on drug dosages and administration information are to be entered in the appropriate appendix.

Note: For studies conducted at the REC’s with production animals, only list those procedures that exceed the standard of management practices.

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  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 [ethical categories examples are found at the IACUC website] 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, “dummie” models 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 UTK-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.

Note: The USDA Policy #11 considers prolonged restraint and food restriction to be distressful and potentially painful. It is necessary for PIs to assure the IACUC that alternatives to procedures that cause more than momentary or slight pain or distress have been considered.

If yes, please list the painful procedure:

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Only protocols involving research or teaching animals regulated by the USDA are required to complete an alternatives search for painful and distressful procedures.

To help determine if any research or teaching animals on this protocol are USDA regulated, answer the following questions. (Note: it is possible some, but not all, animals on a protocol are regulated. In this case, an alternatives search would be needed.)

  1. Does this research involve only the use of birds, reptiles, amphibians or fish? If yes, then skip to Section E. If no, then continue to the next questions.
  2. Does this research involve only the use of rodents of the genus Mus or Rattus and/or the above classes of vertebrates (birds, reptiles, amphibians, and fish)? If yes, then skip to Section E. If no, then continue with the questions below.
  3. Does this research involve only the use of livestock used for food or fiber, improving nutrition, breeding, and management or production efficiency in food or fiber animals? If yes, then skip to Section E. If no, then continue below.
  4. Does this research involve only the use of client owned animals? If yes, then skip to Section E. If no, continue below.

The Animal Welfare Act regulates all other research or teaching mammals (including livestock used for biomedical research or teaching veterinary students, and rodents of species other than Mus and Rattus). Protocols involving regulated animals that undergo a procedure reasonably expected to cause more than slight or momentary pain and/or distress in a human must include a literature search. It is highly recommended to consult with a librarian so that this search is appropriate.

For information on conducting an Alternatives search and appropriate databases, please visit or

Please Note: Google Scholar is not an acceptable primary database. Google Scholar is an acceptable “Other Source” searched.

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. A minimum of 2 databases must be searched.

Database 1 / Database 2
Name of Database searched * / Click here to enter text. / Click here to enter text.
Date of search (must be within 6 months of protocol submission) MM/DD/YY / Click here to enter text. / Click here to enter text.
Years covered by search (YY – YY) / Click here to enter text. / Click here to enter text.
Search strategy (must show how keywords were combined) / Click here to enter text. / 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. Please indicate below the clinical signs being evaluated during monitoring which are direct results of the manipulations done in the research or teaching.

Please check all that apply (Placing your cursor over the box and clicking twice will place the “X” inside the box):

☐ / Does not apply since the study is short-term and abnormal health conditions are not expected following the activities on the protocol. (Examples include single blood draw studies in client animals or colony animals before returning to owner or colony protocol, wildlife studies where animals are captured for a moment, then released, or teaching classes with handling only.)
☐ / loss of appetite. If checked, how will appetite be monitored?
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☐ / loss of weight- * note: best for dogs, cats and other large animals
maximum amount or % weight loss:
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frequency of evaluation(s):
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☐ / Body condition score- * note: most appropriate for rodents.
(explain/attach scoring method):
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frequency of evaluation:
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score at which veterinary consultation will be initiated:
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score at which animal will be euthanized:
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☐ / restlessness/ distress
☐ / abnormal resting postures in which the animal appears to be sleeping or is hunched up
☐ / licking, biting, scratching, self-mutilation, shaking or guarding (protecting a painful area)
☐ / failure to show normal patterns of inquisitiveness
☐ / failure to groom, causing an unkempt appearance
☐ / loss of mobility
☐ / lethargy or lack of energy
☐ / labored breathing
☐ / other, please describe:
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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. VETERINARY CARE

Which veterinarian(s) is/are responsible for clinical care or consultation?

☐ / Office of Laboratory Animal Care (OLAC) veterinarians
☐ / Large Animal Clinical Sciences (LACS) veterinarian in consultation with the LACS Department Head and OLAC
☐ / Small Animal Clinical Sciences (SACS) veterinarian in consultation with the SACS Department Head and OLAC
☐ / Local Practitioners (Research and Education Centers [REC], field trials)
☐ / Other, Name:
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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 / Source / Total # Animals Requested
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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.

Please identify the approaches listed below used to justify the number of proposed animals for this study and provide an explanation. More than one justification may be applicable for different studies within the protocol.

☐ / Citation of previous research – Describe how the previous study is theoretically, conceptually, or physiologically similar to the proposed study. State the values that are being used to conduct an a priori sample size calculation (e.g. means and standard deviations, medians and interquartile ranges, or proportions) as well as the alpha value, beta value (1-beta = power), choice of one-tailed or two-tailed hypothesis, and the final sample size yielded from the calculation. Most studies are powered at .80 and use an alpha value of .05. If basing animal numbers on previously published data, please include the citation(s).
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☐ / Statistical analysis – If the focus of the study is to detect statistically significant differences between independent groups (between-subjects), across time (within-subjects), or in the multivariate sense (multiple regression, logistic regression), an a priori sample size calculation is required. Contacting a statistician can help immensely when trying to calculate an adequate sample size that can meet the requirements of statistical power. For assistance, you may contact the statisticians of OIT's Research Computing Support group by calling the OIT HelpDesk at 4-9900 or completing the form at .Include the name of the individual who was consulted to determine the animal number request.
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☐ / Pilot studies are conducted when there is not an evidence-based measure of effect size to base an a priori sample size calculation on, when trying to generate hypotheses, or when moving into a new area of science. Specify the outcome, the scale of measurement of the outcome (categorical, ordinal, or continuous), and a general idea of what constitutes a “successful” outcome (e.g. 50% reduction in tumor size in three months). Pilot studies are often conducted to generate an effect size for a future larger study. Explain how the results of the pilot study will lead to a future larger study.
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☐ / Teaching or Training – include information related to teaching or training (i.e. number classes/labs per year, number of students per class, number of students per animal, number of times each animal will be used).
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☐ / Breeding Colony - Please provide scheme for maintaining a breeding colony of animals to be used on this or other research protocols. (Jax Lab has valuable information on breeding rodents, which can be found at This site includes a Breeding Colony Size Planning Work Sheet.)
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☐ / Other – Please describe. (i.e. entire herd of animals)
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  1. Animal Housing and Use Areas

Please check your preferred housing location. Animal housing space is assigned by the Attending Veterinarian. Every reasonable attempt will be made to accommodate investigator requests for preferred housing locations.

☐ / Walters Life Sciences Animal Facility (WLS)
☐ / Jessie Harris Animal Facility
☐ / CVM Animal Facilities/Clinics (LACS, SACS, VREC)
☐ / UT Medical Center Animal Facility
☐ / Joe E. Johnson Animal Research and Teaching Unit
☐ / Research and Education Centers – Provide location information:
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☐ / *UTK-IACUC Approved Satellite Facility
List Bldg./Room #:
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☐ / Other. Please describe:
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*Any location housing animals for greater than 12 hours must be inspected. Information on establishing a satellite facility may be obtained from the UTK-IACUC office.

  1. If all procedures will be done in the animal facility listed above where animals are housed, please mark this box and continue with Section E. ☐

If animal procedures (including euthanasia) will be conducted in a building or room separate from animal housing, please identify the building and room number. New animal use areas must be inspected prior to use. You will be notified if the room/area needs to be inspected.