protocol form - university of...

Submit 1 electronic Word version of the protocol to: [email protected]. 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):

Click here to enter text.

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 [email protected] 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.

FOR UTK-IACUC USE ONLY:Approval Date: Click here to enter text. Review Process: ☐ Full ☐ DMRUTK-IACUC Number:

Click here to enter text. Biosafety:Chemical:Radiation:

USDA:

☐☐☐☐

Exception to Guide:MOU:

Wildlife:Ag Animal:

☐☐☐☐

Exception to AWA:Restraint:

MMSS:Consent Form:

☐☐☐☐

Pain/Distress Category:


PROTOCOL FORM(FOR USE OF LIVE VERTEBRATE ANIMALS) v 9/17

336 Ellington Plant Sciences Bldg.2431 Joe Johnson Drive

Knoxville, TN 37996-4564P: (865) 974-5547F: (865) 974-5587

mailto:[email protected]

mailto:[email protected]

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.

I. GENERAL INFORMATION

A. This protocol:

☐ New ☐ 3-Year Rewrite (Please provide a brief description of research progress to date.Click here to enter text.

☐ Holding ☐ Breeding ☐ Research ☐ Teaching

Course/CE Name: Click here to enter text.

☐ 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)

B. Funding Source for this protocol:


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) Species2) Animal Numbers3) Procedures

C. Non-Technical SummaryBriefly 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.


D. Flow ChartProvide 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.

Click here to enter text. of 37

II. ANIMAL WELFARE

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


C. DuplicationThe 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.


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 UTK-IACUC is responsible for ensuring that investigators have appropriately considered alternatives.

Does this study/activity include painful or distressful procedures? ☐ YES ☐ NOIf 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.

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If yes, please list the painful procedure:

Click here to enter text.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 http://libguides.utk.edu/veterinaryinformation/IACUC or http://www.nal.usda.gov/awic/alternatives

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 2Name 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. of 37

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

http://libguides.utk.edu/veterinaryinformation/IACUC

Search strategy (must show how keywords were combined)


Other sources consulted. Provide individuals’ name, qualifications, date and summarize content


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-beingAnimals 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?


☐ loss of weight- * note: best for dogs, cats and other large animals

maximum amount or % weight loss:


frequency of evaluation(s):


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☐ Body condition score- * note: most appropriate for rodents. (explain/attach scoring method):


frequency of evaluation:


score at which veterinary consultation will be initiated:


score at which animal will be euthanized:


☐ 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:


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 studyIf 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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III. 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:


IV. 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 Source Total # Animals Requested USE TAB KEY TO INSERT MORE LINES AS NEEDED

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.

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). Click here to enter text.

☐ Statistical analysis – If the focus of the study is to detect statistically significant differences between

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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 http://help.utk.edu. Include the name of the individual who was consulted to determine the animal number request. Click here to enter text.

☐ 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. Click here to enter text.

☐ 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).Click here to enter text.

☐ 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 https://www.jax.org/jax-mice-and-services/customer-support/technical-support/breeding-and-husbandry-support/colony-planning. This site includes a Breeding Colony Size Planning Work Sheet.)Click here to enter text.

☐ Other – Please describe. (i.e. entire herd of animals)Click here to enter text.

C. 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:


☐ *UTK-IACUC Approved Satellite Facility

List Bldg./Room #:Click here to enter text.

☐ Other. Please describe:Click here to enter text.

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https://www.jax.org/jax-mice-and-services/customer-support/technical-support/breeding-and-husbandry-support/colony-planning

https://www.jax.org/jax-mice-and-services/customer-support/technical-support/breeding-and-husbandry-support/colony-planning

http://help.utk.edu/

*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.

D. 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.

Building Room Number Animal Manipulations Estimated Use Time at Site (specific to this study/protocol)

USE TAB KEY TO INSERT MORE LINES AS NEEDED

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

If “YES”, please complete:

☐ Sterile Cages☐ Wire Bottom Cages*☐ No Enrichment*☐ Social Isolation*☐ Individually Housed*☐ Other. Please describe:


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


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F. Will animals be transported from primary housing location? ☐ YES ☐ NOIf yes, animals should be transported according to the approved IACUC SOP on Transportation. (See link below). If special considerations are not included with the checkboxes below, provide information in the textbox below. If separate parties are involved for transport and receiving during the transportation, verbal communication is required immediately prior to loading and transport.

☐ Animals will be transported by REC or LAF personnel following the Transportation Policy.☐ Animals will be transported in a personal vehicle by someone listed on this protocol following the

Transportation Policy☐ Animals will be transported on a cart or on a leash from the animal housing area to the procedure area by

someone listed on this protocol following the Transportation Policy.

http://iacuc.utk.edu/policies-and-procedures Then choose “Standard Operating Procedures for Transportation of Animals at UTK”.

Click here to enter text.G. Planned disposition of the animals after completion of the activity. If euthanized, what will happen to the

carcass?


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http://iacuc.utk.edu/policies-and-procedures

V. 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. If applicable (lists on file in the IACUC Office), the terms “List of Approved Vet Techs and Vet Assistants” or “List of Approved Animal Science Faculty/Staff/Graduate Students” may be used. 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.

1Occupational Health Program (OHP) Information: The Occupational Health Program (OHP) is institutionally mandated for all personnel who are directly or indirectly exposed to animals or animal tissue. If an individual having animal contact is not currently enrolled in the OHP, call the Occupational Health Nurse at (865)974-5728 to enroll in the program. OHP updates are required.

2AALAS LEARNING LIBRARY (ALL) 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 UTK IACUC website for training requirements and resources under “Training” at: http://iacuc.utk.edu. Annual Refresher IACUC Training is required. All personnel will be contacted to complete this activity.

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Name + Degree+ email address

OHP1 Enrollment completed and current.

ALL2 completion date or Most recent Mandatory IACUC training date (IACUC office staff have this information)

Procedures this person will perform & relevant experience

USE TAB KEY TO INSERT MORE LINES AS NEEDED

http://iacuc.utk.edu/

VI. EUTHANASIA

Information must be provided for all live animal activities, including a 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 pharmaceutical grade.

☐ Euthanasia is part of the study designOR

☐ Euthanasia is NOT part of the study design

Method of euthanasia:

☐ Anesthetic Barbiturate Overdose (An approved veterinary product): 1 cc/10 lb. by intravenous route☐ Anesthetic overdose

Drug:Click here to enter text.Dose:Click here to enter text.Route:Click here to enter text.

☐ Blunt Force Trauma. Justification:Click here to enter text.

☐ Captive Bolt: ☐ Penetrating or ☐ Non-penetrating followed by secondary method:Click here to enter text.

☐ Carbon dioxide (CO2) exposure followed by secondary method

☐ CD or ☐ Thoracotomy

☐ Cervical Dislocation (CD) under anesthesia or tranquilization (if yes, complete Appendix L)☐ Conscious Cervical Dislocation. Justification:

Click here to enter text.☐ Conscious Decapitation. Justification:

Click here to enter text.☐ Decapitation under anesthesia or tranquilization (if yes, complete Appendix L)☐ Exsanguination following anesthesia, stunning, captive bolt or CO2 (if anesthesia, complete Appendix L)

Is Perfusion involved?☐ NO☐ YES. Please provide details:Click here to enter text.

☐ Slaughter (covered under the Humane Slaughter of Livestock, 9 CFR, Part 313)☐ UTK-IACUC approved SOP for euthanasia at UTK REC☐ Other. Specify:


VII.

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

VIII. ANIMAL PROCEDURES

Please check all the needed procedures by placing your cursor over the box and clicking will place the “X” inside the box. Press the CTRL key your keyboard and click on links highlighted in yellow to go directly to the selected appendix. Procedures denoted by an asterisk* have UTK IACUC approved guidelines. Deviations from these guidelines must be justified. Please see the following website for more details: http://iacuc.utk.edu/policies-and-procedures/

☐ A. Use of Recombinant Material, including recombinant/synthetic nucleic acid molecules; genetically modified microorganisms, viruses, cell lines; vaccines or therapeutic agents; transgenic plants and/or transgenic animals. If yes, complete Appendix A.

☐ B. Substance(s) collected from live animals (Blood*, or other body fluid withdrawal, tissue collection, tail clip*; do not list collections post mortem). If yes, complete Appendix B.

☐ C. Substance(s) administered to live animals (Gavaging, injections). If yes, complete Appendix C.

☐ D. Are animals restrained for purposes other than routine care and use (routine care and use includes cattle in a chute, mouse in restrainer for blood collection. If yes, complete Appendix D.

☐ E. Projects involving food and water deprivation or dietary manipulation. If yes, complete Appendix E.

☐ F. Temperature/light/other environmental manipulations. If yes, complete Appendix F.

☐ G. Tumor models*, disease models, or toxicity testing. If yes, complete Appendix G.

☐ H. Behavioral studies. If yes, complete Appendix H.

☐ I. Endoscopy, fluoroscopy, radiology, ultrasound, MRI, CT, PET, or other imaging procedures. If yes, complete Appendix I.

☐ J. Wildlife field studies. If yes, complete Appendix J.

☐ K. Controlled exercise (treadmills, forceplate, and balance balls). If yes, complete Appendix K

☐ L. Anesthesia/analgesia*. If yes, complete Appendix L. Note: “When working with research and teaching animals associated with the CVM, please obtain the “crash box” from anesthesia prior to general anesthesia on the patient(s).”

☐ M. Surgical Procedures. If yes, complete Appendix M.

☐ N. Projects involving aquatic animals. If yes, complete Appendix N.

☐ O. Other manipulations not described above. If yes, complete Appendix O.

☐ P. Hazardous agent use (biological, radioactive, or chemical). If yes, complete the Animal Hazard Control Form – Appendix P.

☐ Q. Antibody production*. If yes, complete Appendix Q.

☐ R. Use of tissues, serum, tumor lines, or hybridomas that are of rodent origin. If yes, complete Appendix R.

APPENDIX A – Recombinant Materials

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http://iacuc.utk.edu/policies-and-procedures/

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 UTK:

a. Describe approach or procedure to produce modification:Click here to enter text.b. What gene(s) were intentionally modified:Click here to enter text.c. If known, expected product over expressed / under expressed:Click here to enter text.d. Describe any potentially debilitating phenotypes associated with this animal:Click here to enter text.

Briefly summarize the proposed recombinant materials:


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APPENDIX B – Substance(s) Collected (Blood*, other body fluid withdrawal, tissue collection, or tail clip*)

Substance Collected* Site of collection Method of collection

Amount Collected Frequency of Collection(s)

Use tab key to insert more lines as needed

*Please refer to The UTK-IACUC policies, which include information on blood volume and tail biopsies. Deviations from these guidelines must be justified. Please see the following website for more details: http://iacuc.utk.edu/policies-and-procedures/

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APPENDIX C – Substance(s) Administered (Gavaging or injections)

If administered for anesthesia/immobilization please complete Appendix L. Investigators are required to use pharmaceutical grade drugs and compounds whenever commercially available, even in terminal procedures.

Substance Administered

Route and volume administered

Dose/Concentration

Frequency and Duration of administration

Is this Pharmaceutical Grade?(Enter Yes or No Below)

If No, answer Questions 1-4. If Yes, answer Questions 1-3.

Use tab key to insert more lines as needed

1. Are any adverse events expected following administration of the above substances? (hours for short term/weeks or months for long term):

Please list the potential adverse effects in the text box here.

2. Frequency of observations:


3. Identify the laboratory personnel responsible for monitoring the animal(s) following administration of the above substances. List individual’s names, email address, and provide cell phone numbers.


4. If non-pharmaceutical grade drugs/compounds will be used in live animals (see Guideline posted at the IACUC SharePoint site) list the drugs and/or compounds, how they will be prepared, how they will be used and explain why pharmaceutical grade drugs cannot be used.


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APPENDIX D – Restraint with Mechanical Devices (for procedures other than routine care).

1. Restraint device:


2. For what procedures:


3. Duration of restraint: (If greater than 4 hours, justification must be provided)


4. Frequency of observations during restraint/person responsible:


5. Frequency and total number of restraints:


6. Conditioning procedures:


7. Steps to assure comfort and well-being:


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APPENDIX E – Projects involving food and water deprivation and dietary manipulation(Excluding routine pre-surgical fasting).

The USDA considers food and/or water deprivation to potentially be painful and/or distressful. Please review the information on Policy 11 at this link: https://www.aphis.usda.gov/animal_welfare/downloads/Animal%20Care%20Policy%20Manual.pdf

1. Food Restriction

a. Amount restricted:


b. Duration (hours for short term/weeks or months for long term):


c. Frequency of observations:


d. Person responsible:


e. Potential adverse events:


2. Fluid Restriction

a. Amount restricted:


b. Duration (hours for short term/weeks or months for long term):


c. Frequency of observations:


d. Person responsible:


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https://www.aphis.usda.gov/animal_welfare/downloads/Animal%20Care%20Policy%20Manual.pdf


e. Potential adverse events:


3. Dietary Manipulations

a. Compound supplemented and amount:


b. Compound deleted and amount:


c. Duration (hours for short term/weeks or months for long term):


d. Frequency of observations:


e. Person responsible:


f. Potential adverse events:


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APPENDIX F – Temperature/Light/Other Environmental Manipulations

1. Describe manipulation(s):


2. Duration:


3. Intensity:


4. Frequency:


5. Potential adverse events:


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APPENDIX G – Tumor Models*, Disease Models, or Toxicity Testing

*The UTK-IACUC has approved guidelines for these procedures. Deviations from these guidelines must be justified. Please see the following website for more details: http://iacuc.utk.edu/policies-and-procedures/

1. Describe methodology:


2. Expected model and/or clinical/pathological manifestations:


3. Frequency of observations:


4. Person responsible for oversight of animals:




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APPENDIX H – 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:




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APPENDIX I – Endoscopy, Fluoroscopy, Radiology, Ultrasound, MRI, CT, PET, or Other Imaging Procedures

1. Describe which imaging procedure will be used on the animal:


2. Duration of procedure:


3. Frequency of observations during procedure:


4. Frequency/total number of procedures:




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APPENDIX J – Wildlife Field Studies

1. List 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. 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: Click here to enter text.

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: Click here to enter text.

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


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h. Precautions used to minimize injury and/or mortality? Click here to enter text.

i. Describe method(s) used to sanitize capture devices between capture locations or groups of individuals. Click here to enter text.

5. Capture with chemical immobilization (Anesthetizing drugs are covered under Appendix L, this section covers the mechanics).

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. (Also, complete Appendix L)


6. Marking/Telemetry Procedures

a. Describe marking procedures to be used: Click here to enter text.

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 (for surgical attachment, complete Appendix L and M)

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4. Will marking/telemetry device be removed? ☐ YES ☐ NOIf yes, explain how:


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

a. Where will captured animals be released? Click here to enter text.

b. If the animals are transported indicate the method of transportation. Click here to enter text.

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


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


8. Non-Survival Collection

a. Describe procedure(s) to be used.


b. Describe precautions that will be taken to prevent non-target mortalities. Click here to enter text.

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APPENDIX K – Controlled Exercise (Treadmills, Forceplate, Balance Balls)

The USDA considers forced exercise to potentially be painful and/or distressful. Please review the information on Policy 11 at this link: https://www.aphis.usda.gov/animal_welfare/downloads/Animal%20Care%20Policy%20Manual.pdf 1. Describe apparatus used and how used:


2. Describe any stimulus (if used):


3. Conditioning to apparatus:


4. Frequency of events per day:


5. Total number of sessions during this study:




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APPENDIX L – Anesthesia/Sedation/Analgesia/Other Supplementary Drugs or CompoundsAdequate 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.



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



Anesthetic Click here to enter text. Click here to enter text.



Post-procedural analgesics*




Paralytics (need to justify below in question h.)




Other (supplementary drugs or compounds, i.e. Atropine, Vetastarch)




1. LIST EACH NON-PHARMACEUTICAL DRUG, JUSTIFICATION 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, the IACUC approved SOP on recognizing pain and distress must be followed. (Please visit the IACUC website to review the Anesthetics & Analgesics SOP).

2. Reason for administering agent(s):


3. For which procedures:


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


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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APPENDIX M - 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 or nolvasan, 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):


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


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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APPENDIX N – Aquatics

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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APPENDIX O – Other Procedures

Please describe in detail what will be done to animals (this response should provide the UTK-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:




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APPENDIX P – ANIMAL HAZARD CONTROL FORM (AHCF) – IACUC #The Principal Investigator is responsible for informing all personnel handling animals of the hazards involved and precautions to be taken. The Principal Investigator is also responsible for updating the form in the case of changes in agent or experimental procedure. For assistance in completion of this form please contact the appropriate Safety Officer.

Principal Investigator: Click here to enter text.

Campus Phone:


Emergency Phone:


E-Mail:

Click here to enter text.Secondary Contacts: Click here to enter text.

Department: Click here to enter text.

Campus Phone:


Emergency Phone:


E-Mail:


Chemical Agents: Click here to enter text.Radiological Agents: Click here to enter text.

Radiological Materials License Holder: Click here to enter text.

Biohazardous Agents: Click here to enter text.

Infectious to humans (Y/N): Click here to enter text.

Biosafety Level: Click here to enter text.

Required Personal Protective Equipment (PPE): Click here to enter text.

Route of Excretion: Click here to enter text.

Precautions for Handling Live or Dead Animals: Click here to enter text.

Animal Disposal: Click here to enter text.

Bedding / Waste Disposal: Click here to enter text.

Cage Decontamination: Click here to enter text.

Additional Precautions to Protect Personnel, Adjacent Research, and Environment: Click here to enter text.

Study Location(s): Click here to enter text.Form reviewed/approved by:

Date reviewed/approved:

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APPENDIX Q – Antibody Production

1. Polyclonal antibody production

a. Antigen/Adjuvants to be used:


If Freund’s Complete Adjuvant is to be used, concentration of mycobacterium:


b. Route of injection:


c. Location of injection(s):


d. Volume of injection per site:


e. Total number of injection sites:


f. Frequency and maximum number of boosts:


g. Interval between injection and booster:


h. Frequency of monitoring injection sites/who will monitor:


i. What will be done to minimize pain / distress:


j. Adverse effects/endpoints:


2. Monoclonal antibody production

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Please provide scientific justification in the Animal Welfare Section of this protocol explaining why in vitro monoclonal antibody production methods cannot be used. The UTK-IACUC has a monoclonal antibody production guideline document. Please contact the IACUC office for this information. Any deviation from these guidelines must be specified and scientifically justified below.

a. Describe methodology:


b. Adjuvant used: ☐ YES ☐ NOIf yes, name of adjuvant:


Volume of adjuvant:


c. Number of cells to be injected into peritoneal cavity:


Volume of cells:


d. Criteria/signs that will dictate ascites harvest:


e. Will animal be anesthetized before harvest: ☐ YES ☐ NO

f. Total number of taps:


g. How will animals be monitored/cared for following taps:


h. What will be done to minimize pain / distress:


i. Person responsible for monitoring/harvesting ascites:


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APPENDIX R – Use of Tissues, Serum, Tumor Lines, or Hybridomas that are of Rodent Origin

These tissues must be free of rodent infectious agents. Please provide evidence.

1. Source:


2. Species:


3. Tissue type:


4. Provide evidence of appropriate testing or certification (MAP, PCR):


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