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Frequently Asked Questions

On this page, you will find answers to the most commonly asked questions.

 

The IACUC coordinator is available as an information resource for your questions and can be reached at (865) 974-3631 or via email to utiacuc@utk.edu. The members of the Office of Laboratory Animal Care (OLAC) are available to assist investigators with the veterinary aspects of protocol development (for example- drugs to be used to provide anesthesia or analgesia). OLAC also has a “Getting Started Guide” specifically designed to help Principal Investigators with initiating an animal-based research or teaching project.

Statisticians consult at Pendergrass Library and other locations by appointment.

Scheduling is easy. Call 974-9900 (O.I.T. Ticket System) or by completing the form at http://help.utk.edu.

Cost: First 15 hours per semester are free.

 

A copy of the New Principal Investigator Letter that provides guidance and contact information is provided below.

Dear Principal Investigator (PI):

You are receiving this message as you have submitted a protocol for using animals in research or teaching.  Below is a list of items in regard to the Institutional Animal Care and Use Committee (IACUC) and your protocol.

  • The entire review process can be up to 4 to 6 weeks. Reviews include a veterinary, hazardous agent, occupational health and IACUC review.
  • Please reply promptly if you receive a message from the IACUC office or the IACUC coordinator on any clarifications or additions to the protocol.
  • No work on this protocol can begin until you receive a written correspondence (email or letter) stating that the protocol was APPROVED from the IACUC office.
  • As a PI, it is your responsibility to insure all personnel listed on your protocol have read the protocol, have completed their training and are enrolled in/waived the UT Occupational Health Program.
  • Only people listed on the protocol can work on the project. A personnel amendment must be submitted to the IACUC office before any new personnel can begin work. Amendment forms are available on the IACUC website.
  • If any procedures need to be changed, an amendment must also be submitted and approved prior to initiating the change.
  • If any animals become sick/injured, require veterinary care, display unexpected/unrelated clinical signs, unexpected/unrelated mortality, or a high number of mortality, the IACUC office or the UT Attending Veterinarian must be contacted.
  • If there is an unexpected occurrence or questions arise about any parts of the protocol, please contact the IACUC office.
  • Protocols are approved for a period of 3 years; however, every year you must submit a renewal form to inform the IACUC of the number of animals used and if any personnel need to be removed from the protocol.
  • Annual IACUC refresher training is typically required. As the PI, it is your responsibility to ensure all on your protocol are aware of the training and complete it once notified.
  • Once your protocol is approved, you will be granted access to the IACUC Sharepoint site which allows you to view your protocol, any amendments and other important information.
  • Any time during the life of your protocol, you may be asked to undergo a post-approval monitoring (PAM) session to ensure the work on the animals is as written in the protocol.

Contact Information:

UT IACUC office: email:  utiacuc@utk.edu

SharePoint site for Principal Investigator IACUC Protocol Folders: https://utworks.tennessee.edu/iacuc/

Elizabeth “Betsy” Bailey, IACUC coordinator: ebailey@utk.edu or 974-3631

Jessica Woofter, IACUC Administrative Supportjwoofter@utk.edu or 974-5547

Lori Cole, D.V.M., Director of Animal Compliance Support: lcole21@utk.edu or 974-9074 (office) or 719-0214 (cell)

Any individuals providing animal husbandry or care (with the exception of facility staff) should be listed on the personnel table of the IACUC Protocol Form. All individuals listed will be required to complete an enrollment or waiver form for the Occupational Health Program and the AALAS Learning Library Module “Working with the IACUC” prior to having access to animal facilities. Additional information can be found by clicking on the “Training” link on the left-hand side of the screen.

All issues or questions related to animal husbandry (caging, space availability, per diems for research animals, etc.) should be directed to facility managers. Contact the OLAC Office at (865) 974-5634 to get in touch with the appropriate facility manager.

The up-to-date Animal Care and Use forms are located at on the Forms page.

Amendment forms for either personnel or procedural changes can be found in the red tab mark “Forms“. Institutions with large numbers of approved protocols often use an amendment form to document proposed changes in protocols. Depending on the specific changes requested, questions to be answered for each protocol amendment should include:

  • What is the purpose or rational for the protocol amendment?
  • Will different people use the animals? If personnel have changed, their qualifications (e.g., education, training and experience) must be documented.
  • Will the species, sex of strain of animal change?
  • Will there be specialized housing requirements (e.g., housing that is not standard for the species, or housing which does not meet the animal’s physiological or behavioral requirements?
  • Will more animals be needed? If so, justification for the increased number must be provided.
  • Will additional minor surgical procedures or sampling of body fluids or tissues occur?
  • Are animals expected to experience more clinical illness, pain, or distress as a result of the procedures proposed in this amendment? Are there alternatives to the use of animals in painful procedures? How will any pain or distress from this new procedure be minimized?
  • Will there be new procedures involving animals? Such changes must be described with the same level of detail as is required for a new protocol.
  • Will there be a change in the methods of euthanasia, analgesia, or anesthesia?
  • Will prolonged restraint of conscious animals be required?
  • Will new hazardous agents be used?
  • Will the surgical plans change (minor to major, multiple survival surgery, additional procedures)?

Source: “The IACUC Handbook”

Call the IACUC Office at (865) 974-5547 or 974-3631 and notify us of your situation. You can also email our office at utiacuc@utk.edu.

File 000178 and UTK has received full accreditation by AAALAC

The short answer is: Expect it to typically take 3-8 weeks.

The complete answer is: The review process begins upon receipt of your protocol. An administrative review occurs shortly after protocol receipt to insure that the form has been thoroughly and properly completed. The committee coordinator may contact you with questions or comments which require your attention and responses. Following the administrative review, the protocol is forwarded to the OLAC veterinarians for a review of the veterinary aspects of your planned study. During the veterinary review, the protocol is assigned a pain and distress category based on the described animal procedures. This category is the primary factor determining the method of review by the IACUC and is based on the USDA pain categories.

The Biosafety Office will assess any hazardous risks included in the protocol and the Occupational Health Program (OHP) to review the personnel section of the protocol. The Biosafety Officer and the OHP director may contact the PI with questions. Following released from veterinary review, the protocol is sent to the IACUC chair for reviewer assignment, which is based on protocol content and the pain/distress category.

The UTK IACUC uses designated member review process during which any member of the committee may call any protocol to full committee review. If a protocol is called to full review, the protocol will be discussed at the next scheduled meeting. If the protocol remains in the designated member review process, the committee has seven days during which they may review the protocol and send the selected reviewer comments or questions. After the seven days, the reviewer compiles the questions and comments and sends them to the coordinator, who will contact the PI. The PI will be given specific instructions to revise the protocol to address the questions and comments identified during the review process. Upon receipt of the revised protocol, the coordinator will distribute the revised protocol to the entire committee for a final review period.

Our PHS Assurance includes a 72-hour continued review period. After all questions have been adequately addressed and the protocol is in final version and the protocol completed the 72-hour continued review, the approval letter will be prepared for signature and the protocol will be distributed to key individuals (the PI, animal facility managers, REC personnel, OLAC).

So, how long to receive protocol approval depends on the review process and the turn-around time for questions to be sent and responses to be received from the PI and the committee members.

Amendments need to be submitted before any change is made to a protocol. The chair has authority to approve on behalf of the committee personnel additions (but not a change of the principal investigator) and an increase of animal number of 1 or up to 10% of the original number approved, and minor procedural changes. Amendments are reviewed in a similar method to that of protocols: amendments are sent to the OLAC office for veterinary review and if there is a safety component, the amendment is also sent to the Biosafety Officer. OHP is contacted for personnel additions.

Upon release from veterinary review the amendment is either assigned to the designated member review method, entering the 7 day review process, or the chair can approve the amendment.

A list of current IACUC members is available on the IACUC SharePoint site for Principal Investigators with ACTIVE IACUC protocols. To access this site clicking the “Principal Investigator IACUC Protocol Folders” link on the left-hand side of the screen. For further information, contact the IACUC Office at (865) 974-5547 or email us at utiacuc@utk.edu.

The IACUC meets are held on the first Tuesday of each month unless otherwise posted. A calendar is kept of monthy meeting sites, dates, and times on the IACUC SharePoint site. Principal Investigators with ACTIVE IACUC protocols can access this site by clicking the “Principal Investigator IACUC Protocol Folders” link on the left-hand side of the screen. For further information, contact the IACUC Office at (865) 974-5547 or email us at utiacuc@utk.edu.

The IACUC Office is available at (865) 974-5547 or utiacuc@utk.edu to answer questions regarding animal care and use at the University of Tennessee, procedures related to securing and maintaining approval for the use of animals, animal care issues, and any other questions you may have regarding the animal care and use program. You may also contact any member of the IACUC Administration with questions.

Requirements for training vary based on the species of animal involved in an IACUC protocol. For more information regarding training please see the red tab marked “Training” or contact the IACUC Office at utiacuc@utk.edu.

The UT IACUC employs the USDA pain and distress guidelines to categorize and review protocols. The following examples listed under the guidelines serve as reference points for the IACUC, OLAC and Investigators. Definitive category assignment is based on specific protocol review and committee approval.

USDA Category B:

  • Breeding protocols (including genetic manipulations not expected to result in debilitating phenotypes and euthanasia of offspring prior to weaning)
  • Holding protocols

USDA Category C:

No more than momentary or slight pain or distress and no requirement for use of pain-relieving drugs, or no pain or distress.

Examples:

  1. Holding or weighing animals in teaching or research activities
  2. Observation of animal behavior
  3. Feeding studies that do not result in clinical health problems
  4. Routine physical examinations and diagnostic/treatment procedures such as injections, blood collections, cystocentesis, catheter implantation via superficial vessels (excluding cut-down of peripheral vessels), ultrasound diagnostics, radiographic diagnostics, fine needle aspirates of lymph nodes or masses
  5. Anesthesia/analgesia/sedation for restraint purposes for examination or routine minimally invasive diagnostic procedures such as5 above (excluding retro-orbital or cardiac stick blood collections).
  6. AVMA approved humane euthanasia procedures (excluding exsanguination)
  7. Routine agricultural husbandry procedures as outlined in the Guide for the Care and Use of Agricultural Animals in Research and Teaching (ex: ear tagging, freeze branding, subcutaneous implants in livestock, caustic paste method of dehorning, closed castration if <2mos and <230 kg)
  8. Methods of identification such as pre-weaning toe clipping and tail clipping (excluding these procedures beyond weaning), wing banding at any age, ear notching at any age
  9. Live trapping with minimal restraint allowing for normal postural adjustments for up to 12 hours
  10. Positive reward projects
  11. Polyclonal antibody production under IACUC approved guidelines (excluding Complete Freund’s Adjuvant)

USDA Category D:

Pain or distress appropriately relieved with anesthetics, analgesics and/or tranquilizer drugs or other methods for relieving pain or distress.

Examples:

  1. Non-survival surgical procedures (Animals euthanized while still under surgical anesthesia)
  2. Terminal exsanguination under anesthesia or in a state of unconsciousness (ex. CO2, isoflurane or captive bolt)
  3. Escapable noxious stimuli or a noxious stimulus with a defined end point occurring prior to permanent tissue damage
  4. Diagnostic procedures such as laparoscopy, bone marrow aspiration, punch biopsies, tru cut biopsies
  5. Exposure of blood vessels via cut-down for catheter implantation
  6. Retro-orbital and cardiac blood collection
  7. Tail and toe clipping beyond weaning; tattooing at any age
  8. Minor survival operative procedures do not penetrate a body cavity; examples are subcutaneous implants (ex. Osmotic pump), most methods of dehorning, open castration in calves >2 mos or >230 kg

Protocols involving any of the following procedures are required to undergo full committee review.

  1. Major survival operative procedures penetrate and expose a body cavity, produce substantial impairment of physical or physiologic functions or involve extensive tissue dissection or transection; examples are laparotomy, craniotomy, thoracotomy, joint replacement and limb amputation

USDA Category E:

Pain or distress or potential pain or distress that is not relieved with anesthetics, analgesics and/or tranquilizer drugs or other methods for relieving pain or distress. All assigned to Full IACUC Review.

Examples:

  1. Any procedures for which needed analgesics, tranquilizers, sedatives or anesthetics must be withheld or delayed for justifiable study
  2. Any procedure that results in a moribund condition or in which death is the endpoint.
  3. Euthanasia by procedures not approved by the
  4. Use of paralyzing or immobilizing drugs for restraint in a conscious animal.
  5. Ocular or skin irritancy testing without post-exposure
  6. Prolonged food or water deprivation (beyond that necessary for ordinary pre-surgical preparation – this is species dependent)
  7. Prolonged restraint (> 4 hrs.) with restriction of normal postural adjustment
  8. Application of noxious stimuli such as electrical shock if the animal cannot avoid/immediately escape the stimuli and/or it is severe enough to cause injury or more than momentary pain or
  9. Infliction of burns or trauma without anesthesia
  10. Permitting recovery of consciousness after severe trauma under anesthesia
  11. Exposure to abnormal or extreme conditions such as heat stress, cold exposure, social isolation
  12. Psychotic-like behavior suggesting a painful or distressed status
  13. Monoclonal antibody production with ascites method
References
  1. APHIS (Animal and Plant Health Inspection Service).  US Department of Agriculture. 2005. Animal Welfare Act and Regulations. Washington DC: USDA  2.31.and 2.36
  2. NRC (National Research Council). 2011. Guide for the Care and Use of Laboratory Animals 8th Washington, D.C.: National Academy Press.Pp.120-123
  3. PHS (Public Health Service). 2002.  Public Health Service Policy on Humane Care and Use of Laboratory Animals.   Department of Health and Human Services, National Institutes of Health, Office of Laboratory Animal Welfare.

 


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