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Instructions for the AVAU

General Information

Use the Application for Vertebrate Animal Use. Previous versions of the form will not be accepted for review.

North Carolina State University policy requires an approved Application for Vertebrate Animal Use (AVAU or “protocol”) for all activities involving the use of live vertebrate animals (research, teaching, public service; intramurally or extramurally funded regardless of source or amount; and including animals being bred, conditioned, or held for future use). The AVAU is a form that allows the investigator or instructor to communicate to the Institutional Animal Care and Use Committee (IACUC) their reasons for and methods of animal use. The IACUC is charged with overseeing all aspects of animal care and use at NCSU. The IACUC may approve, require modification of, or withhold approval from a project. Animal use in the absence of IACUC approval is a serious violation of University policy and a violation of federal law.

Persons submitting an AVAU must be of faculty rank or EPA staff with approval of the department chairperson (Principal Investigators). Principal Investigators (PIs) are responsible for animal use by their students and staff. The PI heading a research group or teaching a course must have an approved application on file for each project or course under his/her supervision. Collaborators, technicians, and students must care for and use animals according to the protocols described in the approved applications. Deviations should be reported to the IACUC. PIs must become familiar with laws, rules and regulations governing animal care and use as well as policies governing the review of animal care and use. Such information can be obtained from the University Attending Veterinarian (phone 919.513.8142, e-mail Steve_Dempsey@ncsu.edu).

Most protocols are reviewed and processed in about four weeks. On occasion, an individual protocol may require a longer period of time because of the nature of the proposed use or other complicating factors. Therefore, it is prudent to submit the forms to the IACUC as soon as the need is anticipated. The IACUC cannot expedite the review of an application because the investigator failed to submit it in time to meet various deadlines. It is the responsibility of the principal investigator to submit an AVAU with sufficient lead-time to meet all University and agency deadlines.

Under certain circumstances, it may be possible to cover vertebrate animal use for more than one project under a single AVAU. For example, resubmission of a grant within one year of approval of an AVAU to the same or another funding agency which may involve changes in title, size of project, or contain other changes, but for which the scope of animal use (procedures, numbers, duration) does not significantly change. Co-submission of the same proposal to two or more granting agencies requires only one Application for Vertebrate Animal Use. Resubmission of an unfunded proposal will not require re-review as long as it is not significantly revised over the previous submission and as long as the previous submission was within the last 12 months. A renewal of a previously funded project does not require animal use re-review as long as it has not been significantly revised and has been reviewed by the Committee within the last three years.

While the IACUC does not conduct inspections of field and overseas research sites, the use of vertebrate animals by PIs is expected to be in accordance with University policy. That portion of vertebrate animal use conducted at NCSU in collaboration with outside researchers must be reviewed by the NCSU IACUC, even if it has already been reviewed by an IACUC or similar committee at the collaborating institution. NCSU investigators participating in vertebrate animal research conducted at other sites that has been reviewed and approved by IACUCs at other institutions may not be required to submit an application to the NCSU IACUC. However, the NCSU IACUC requires investigators to submit a copy of the IACUC approval from the other reviewing institution. The NCSU IACUC must be allowed to assess whether or not an application should be submitted to our office under these circumstances. With regard to collection of tissue samples (i.e. biopsies, blood, etc.), if samples are being collected expressly for the purposes of an NCSU investigator's research or teaching projects, that investigator must file an application for vertebrate animal use with the NCSU IACUC. For example, clinically necessary biopsies and blood samples may be split for research purposes without IACUC review, but no clinically unnecessary sample maybe taken without IACUC review and approval. This policy also applies to field studies in which samples are being collected expressly for the purposes of an investigator's research or teaching projects and to studies covered by government permits. The IACUC must review these projects.

An AVAU (protocol) is approved for one year. The PI is required to submit an annual renewal form in order to request renewal of IACUC approval. The IACUC Administrator notifies the PI that a renewal form is due at the appropriate time. After three years of approval, the AVAU must be re-written and undergo the entire review process again.

If significant changes are anticipated in an on-going project, a Protocol Amendment Form must be submitted to the IACUC office for review and approval prior to initiation of these changes. Consult the IACUC office (phone 515-7507, e-mail iacuc@ncsu.edu ) for information.

Applications may be obtained from this website: http://www.ncsu.edu/sparcs/iacuc/docs/avau.doc. Handwritten forms will not be accepted. Each section must be answered in specific detail or noted "not applicable". It is not sufficient to answer a question by simply referring to a more detailed paper or reference or attached document. However, copies of syllabi are needed for teaching activities, and clinical studies using client-owned animals require the submission of a copy of the client informed consent form. Submit all applications through the IACUC office. Submit the AVAU as an MSWord document by email to iacuc@ncsu.edu. If you cannot scan your signature into the investigator’s assurances page, print out that page, sign and date it, and mail it to NCSU IACUC Office, Campus Box 7514, Raleigh, NC 27695-7514. If you have questions, contact Judy Lassiter, IACUC Regulatory Compliance Administrator at (919) 515-7507 or by email at iacuc@ncsu.edu. After review and approval, the IACUC Office will send the approval information to the Principal Investigator for submission to the appropriate offices or federal agencies.

General References on Animal Care and Use

Specific Form Instructions by Section

The following are specific page-by-page instructions on completing the AVAU form, found at http://www.ncsu.edu/sparcs/iacuc/forms.html. Numbers refer to the numbered items of the AVAU form. Handwritten forms will be returned.

Cover Page:

The AVAU form has 2 major sections, the Confidential Section and the Public Section. Both sections must be completed. The Confidential Section is not subject to release under NC Public Records Law.

Confidential Section:

  1. There are occasions in which the PI will not require animals to remain in a research setting such as those animals used in field studies and client-owned animals that will remain with their owners throughout the study. Locations of field studies must be specific.
  2. For animals that will remain at the research facility, provide the name of the facility and the room number.
  3. List locations where procedures will be performed. Location of surgery areas should also be included here. (Examples: 1. Rat ovariectomy, BRF room 216, 2. Oral dosing of cats, LAR, room F226.) Procedures performed in investigator’s laboratory or at an off-campus site should be listed in 4.
  4. Provide the location of the investigator’s lab, holding or use area outside of the animal facility or the off-campus site, and the duration of the animal’s stay. Facilities must be inspected and approved by an IACUC inspection team prior to animal use. Any area where animals are used or maintained for 12 hours or more is subject to semiannual IACUC inspection. Contact the IACUC Administrator to arrange an inspection (919.515.7507, email iacuc@ncsu.edu ).
  5. Transportation of animals must conform to all federal regulations and guidelines. Transporting animals from their housing area requires proper containment of the animal in a secure cage, pen, etc. with appropriate supplies, as necessary, for trip. Method of transport (hand-carry, car, airplane, etc.) must be listed.

Personnel Information Section

Be sure to list the P.I. or instructor (even if he or she does not actually handle the animals), his/her qualifications and experience, and role in the project. The same information should be provided for all individuals who will be working without the direct (physically present) supervision of the P.I. or instructor.

Animal Subjects Tutorial (IACUC Training Requirement): All PIs and other individuals listed on the AVAU form who work with animals unsupervised (without supervisor physically present) must complete the NCSU Animal Subjects Tutorial. This includes the PI or course instructor, even if he/she will not work directly with the animals. It does not include students participating in courses under the direct supervision of the instructor or other supervisory personnel listed on a teaching protocol. For individuals involved in animal use, years of experience with the animal species listed and years of experience performing the procedures described must be included.

Occupational Health and Safety Requirement: The purpose of the Occupational Health and Safety Program for Personnel with Animal Contact is to minimize the health and safety risk of working with vertebrate animals to an acceptable level. Please go to the NCSU Vertebrate Animal Contact Questionnaire. This questionnaire should be submitted in a sealed envelope to Mrs. Martha Barrick, Occupational Medicine Coordinator, Student Health Services, Campus Box 7304. If you have questions about the Vertebrate Animal Contact Medical Questionnaire, please contact Mrs. Barrick at Martha_barrick@ncsu.edu or 513-0277.

“For Section G: Consideration of Alternatives (Animal use categories D and E)”

Complete this section if individuals have been consulted in regards to the proposed animal activity. This will avoid releasing information in public sections of the form, such as Section G.

Assurance: Several assurances are required of the PI as set forth by federal regulations and guidelines. Review carefully to be sure that these assurances are being met. Contact the IACUC Office (phone 515-7507, e-mail mailto:iacuc@ncsu.edu), the IACUC Chairperson (phone 515-7507, e-mail iacuc@ncsu.edu), or the University Attending Veterinarian (phone 513-8142, e-mail Steve_Dempsey@ncsu.edu ) if you have questions. Contact Environmental Health & Safety (phone 919/515-6858) for more information regarding Occupational Health & Safety issues.

Your signature (handwritten, scanned or electronic) indicates that you have read and agree to comply with the assurances. P.I.s and instructors may submit protocol forms by email through their own email accounts, typing their name into the signature line. If a student, technician or secretary submits a protocol electronically on behalf of the investigator or instructor, a signed hard copy of the investigator assurances page must be submitted to the IACUC Office to document the file.

Public Section:

Section A. Animal Care and Use

  1. The purpose and importance of the animal use activity should be written in language that can be understood by laypersons and non-scientists. The response to this item should demonstrate a correlation to the procedures and/or manipulations. For those teaching a class, summarize the class and expected goals for the students. Abbreviations and acronyms must be defined.
  2. Procedures and manipulations that are being performed on the animals must be described in detail from the time the animals enter the study until they are euthanized or otherwise terminated from the study. Again, language must be used that can be understood by laypersons or non-scientists. Surgery should be described in Section E.
  3. Explain why live vertebrate animals must be used in the proposed activity. Address why computer models, visual aids and other non-animal techniques cannot be used.
  4. Explain why the species selected is a good choice for the proposed activity.
      • species and strain: Latin name is not necessary, but common name must be provided. In field studies be sure to indicate non-target species as such.
      • age and/or weight: Give either, or both if known. Alternately, ranges may be used.
      • source: Self-explanatory. Do not give specific vendor names!
      • categories of use: Based on the proposed activities that may cause pain or distress.  See guidance on pain and distress levels at: http://www.ncsu.edu/sparcs/iacuc/forms.html
      • total number of animals: Include the maximum number of animals that are needed for the three-year life of this specific protocol. Do not use ranges of numbers (such as “10 to 15”).
    2. Check the appropriate answer
    3. Check the appropriate answer
    4. Check the appropriate answer
    5. Explain how it was determined to use the number of animals shown in 5a. The numbers should be based on experimental design. Tables or flow charts can be used to show treatment groups and number of animals. Example: 10 animals in each group, 3 treatments (treatment A, treatment B and control), and two replicates of each treatment. 10x3x2=60 (should be same number as “total” in 5a). Explanation should include, when appropriate, a statistical justification for group size. If group sizes range, use the larger number to calculate the total. Account for total animals used in accordance with the approved IACUC Guideline for tracking animals.

Section B: Invasive Sample Collection

Only include those sample collections that are invasive. Example: Fecal collection from floor dropping should not be listed here. Fecal collection by fecal loop should be described here.

Section C: Substance Administration

This section should be used to address substance administration, including implants or devices. Complete Sections D and F for anesthetics, analgesics, tranquilizers and euthanasia agents.

  1. Contact EH&S (phone 515-6858) for additional information. Contact the University’s Attending Veterinarian (919.513.8142 or mailto:Steve_Dempsey@ncsu.edu) for information on mouse antibody production testing, rat antibody production testing and hamster antibody production testing. The use of implants or devices should be described under “other”.
  2. Self-explanatory.
  3. Self-explanatory.
  4. Self-explanatory.

Section D: Potential Pain and Distress

Proper use of animals including the avoidance of discomfort, distress, and pain when consistent with sound scientific practices is imperative. Unless the contrary is established, PIs should consider that procedures that cause pain or distress in human beings might cause pain or distress in other animals.

  1. Self-explanatory.
  2. The plan for checking the animal’s condition must be thoroughly outlined, including specific information on the provisions for euthanasia should it become necessary.
  3. Self-explanatory.
  4. Scientific justification must be provided on why pain relieving drugs or therapies are not acceptable in the proposed activity for animal use.
  5. If animals cannot be euthanized explain how the information derived from allowing the animals to die without intervention contributes to the proposed animal use purpose and importance.
    1. All drugs including anesthetics, analgesics, antibiotics, paralytics, etc. that will be given to animals should be listed here. Painful procedures in which paralytics are used also must include anesthetics. Refer to the IACUC Guidelines on Intra and Post Operative Monitoring and Record Keeping.
    2. Describe how it will be determined that animals are sufficiently anesthetized and how vital signs are being monitored.
    3. Describe how the animal’s recovery from anesthesia will be monitored.
    4. Describe how it will be determined that analgesics are working.
  7. Restraint: It is important that any restraint device be suitable in size and design for the animal being held. Prolonged restraint should be avoided unless essential to the study’s objectives. The restraint device must be correctly operated to minimize stress and avoid injury to the animals. Any drugs used to facilitate restraint should be listed in Section D. Whenever possible the animals should be conditioned to the restraint device.
  8. Self-explanatory.
  9. Exceptions to standards: Contact the IACUC office (phone 515-7507, e-mail mailto:iacuc@ncsu.edu), the IACUC chairperson (phone 515-7507, e-mail mailto:iacuc@ncsu.edu), or the University Attending Veterinarian (phone 513.8142, e-mail mailto:Steve_Dempsey@ncsu.edu) for questions. Federal regulations, guidelines and standards for laboratory animals can be found in the Guide for the Care and Use of Laboratory Animals, the Animal Welfare Act Regulations, the Public Health Service Policy on the Humane Care and Use of Laboratory Animals and the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching.

Section E: Surgery

  1. Check the appropriate box. In non-survival surgery the animal is not allowed to recover from anesthesia, but is instead euthanized.
  2. Self-explanatory.
  3. Explain how long the animals are maintained for the proposed animal use after surgery.
  4. Appropriate procedures for post-operative care of the animals in accordance with established veterinary medicine and nursing practices must be provided. Refer to the IACUC Guidelines on Intra and Post Operative Monitoring and Record Keeping.
  5. This section should be used to address multiple survival surgery. A second surgery that is terminal does not require justification. Major surgery means surgical intervention that penetrates and exposes a body cavity or any procedure that produces permanent impairment of physical or physiological functions. Complete this information in D.

Section F: Euthanasia/Disposition

  1. Self-explanatory.
  2. The American Veterinary Medical Association (AVMA) has set forth guidelines on euthanasia; the panel has determined that cervical dislocation and decapitation should be used only “when scientifically justified by the user.” The NCSU IACUC has determined that exceptions to the AVMA guidelines will be considered by the IACUC on a case-by-case basis.
  3. If animals will not be euthanized, information on final disposition must be provided (i.e. returned to client owner, transferred to another protocol, adopted, sold for slaughter, etc.). For animals entering the food chain, be sure to adhere to established drug withdrawal periods.

Section G: Alternatives

  1. A literature search should include key words that are likely to address the issue of alternatives. In many databases, a literature search with keywords such as “in vitro models,” “alternative,” “animal models,” etc. will provide information on the use of non-animal alternatives in research.
  2. List any other service used for information concerning alternatives to the proposed animal use procedures. Although the literature search is recommended, other methods may serve as a basis for obtaining information on alternatives.
  3. This can include awareness of the literature due to attendance at various seminars, consultants, etc. It also can include one’s own expertise in the field of the proposed animal use activity. Remember that any colleagues consulted should not be identified in this section (see Confidential Section, above).
  4. Provide a written narrative of how it was determined that alternatives to the proposed animal use activity do not exist. Use the information obtained from items 1-3 in Section G to assist in writing this summary.

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