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Instructions for Submitting the Application for IACUC Review

The instructions are broken into 5 parts. You may jump to a specific part of the instructions page by clicking on any of the following links:

These instructions are provided to assist investigators with the completion and submission of the UCI Institutional Animal Care and Use Committee (IACUC) Application to Use Animals in Research or Teaching. Specific instructions, suggestions, and references for each section of the application are provided, including links to many areas of the IACUC and ULAR websites (click on the blue underlined words). Any comments concerning the instructions or the application are welcome and can be made to the IACUC Administrative Office.

For protocols involving invasive procedures such as surgery, a veterinary consultation is strongly recommended. Please contact a ULAR veterinarian to schedule an appointment. Investigators wishing to have their protocols pre-reviewed by the IACUC Administrator or Veterinarian prior to submission (to facilitate review and approval) must submit a draft application at least two weeks prior to the published deadline for which they plan to submit a full committee protocol application.

Office of Research Administration staff are available to assist investigators with protocol submission:

Melanie Fabian
IACUC Administrator
(949) 824-8170
melanie.fabian@uci.edu

Irene Burrows
IACUC Assistant
(949) 824-8664
iburrows@uci.edu

ULAR Veterinarians are also available for consultation regarding protocol design and animal welfare issues:

Jeffrey Goodwin, DVM, Ph.D.
(949) 824-5271
jeffrey.goodwin@uci.edu

Claire Lindsell, DVM, Ph.D.
(949) 824-0569
claire.lindsell@uci.edu

Roger Geertsema, DVM
(949) 824-4666
roger.geertsema@uci.edu

NOTE: Approval of an IACUC protocol does not guarantee that housing space will be available in campus vivaria.

Part 1: Submission Requirements

U.S. Public Health Service (PHS) Policy defines animal as “any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes.” Federal regulations and UCI Policy require that all activities involving the use of animals (e.g., research, testing or teaching), must be reviewed and approved by the Institutional Animal Care and Use Committee (IACUC).

Examples of animal use include:

All new protocols and three (3) year continuing renewal protocols require full committee review. Protocol applications must be received by the Office of Research Administration no later than close of business (5:00 pm unless otherwise stated) on the deadline day to be included on the agenda for the next scheduled full Committee meeting. Protocols received after a deadline may be held until the meeting following the next deadline. See the calendar on the IACUC website for protocol submission deadline dates. Note: Incomplete applications will not be accepted and may be held until the meeting following the next deadline.

The Office of Research Administration is the office of record for the use of animals at UCI. Please retain a copy of your protocol submission (see Lead Researcher Record-Keeping Responsibilities below). An IACUC approval letter will be sent to the Lead Researcher, Faculty Sponsor (when applicable) and Department Chair once the protocol has been approved.

Pre-Requisites

Training in Humane Animal Care and Use:

All study team members must complete the Collaborative Institutional Training Initiative (CITI) Training basic module, "Working with Live Animals in Research" before they can be listed as research personnel on an IACUC protocol. To access the CITI training, go to www.citiprogram.org and click on "New Users Register Here"; this goes to the Course Registration page.

NOTE: If you have recently completed CITI training at a different institution, you can add UCI as a participating institution to transfer your training credit.

Depending on your answers to the screening questions, you may need to complete additional modules, such as:

UCI Animal Facility Access:

Completion of additional CITI training modules is required for access to UCI animal facilities (vivaria). For more information about vivarium access, please select "Training" on the ULAR homepage.

Laboratory Animal Occupational Health Program:

UCI policy requires that all faculty, staff, visiting researchers and students who work directly with vertebrate animals or animal materials (unfixed animal tissues or body fluids) participate in the LAOHP through submission of a completed LAOHP questionnaire to the Occupational Health Program Manager. The questionnaire must be updated and resubmitted at least once per year by all laboratory staff and any other people that have contact with or exposure to laboratory animals.

Other Required UCI Reviews:

Additional regulatory committee reviews and institutional approvals may be required before the IACUC can release approval to work with live animals.

Submission of the IACUC Application

Effective May 2007 IACUC applications are designed for submission via a Web Portal. This process differs from full electronic submission in that investigators will complete the documents on their local computer and upload them via the portal for IACUC review. This method will be used in the interim until the Electronic IACUC Protocol Application (e-APP) module is fully deployed.

  1. To start the process, go to the Forms page and download the Application/Narrative and all applicable Appendices. For guidance on which appendices are required for your research project, please review the IACUC Application Submission Checklist.
  2. Complete the forms, following the specific instructions and guidance in Parts 3 and 4 of this document.
  3. Important: Save each form (Application/Narrative and each individual appendix) as a separate file with a distinct file name on your computer.
  4. Once all parts of the application/narrative are complete, proceed to the web portal and follow the upload instructions carefully. Note: To access the file upload portal, you will need to log in using your UCINetID and password. For more information about UCINetID issues, please contact Network and Academic Computing Services.
  5. Important: Print out one copy of the complete application and all appendices, obtain the original signature of the Lead Researcher (and Faculty Sponsor if required), and deliver this copy to:
    UCI Office of Research Administration
    Institutional Animal Care and Use Committee
    300 University Tower, Zot Code 7600

  6. When a completed protocol application is uploaded, it will be assigned a tracking number. After successful uploading, a tracking confirmation e-mail will be sent to the Lead Researcher.
  7. After preliminary review for completeness, the uploaded files will be entered into the IACUC protocol database and a protocol identification number in the format “2007-1234” will be assigned. This number will be provided to the Lead Researcher in an electronic memo confirming IACUC receipt of the protocol and providing information as to when the protocol will be reviewed.

Part 2: Conditions of Approval

UCI Research Policies

All individuals engaged in the use of animals are responsible for compliance with all applicable UCI Research Policies. The Lead Researcher of the study is ultimately responsible for assuring all study team members review and adhere to applicable policies for the conduct of research involving live vertebrate animals.

PURCHASE OF ANIMALS

All research animal acquisitions must be coordinated through University Laboratory Animal Resources. Animals cannot be purchased, acquired or transferred to UCI until a protocol for their use has been reviewed and approved by the IACUC.

The University uses only purpose-bred animals for research, which are acquired from USDA-licensed Class A vendors. ULAR maintains a list of approved commercial vendors; these sources provide reliable colony health information and present a low risk of contamination to other research animals on campus. Animals from these vendors may enter campus vivaria directly upon arrival. Animals from all other sources, including other educational and research institutions, are subject to quarantine until their health status can be verified.

LEAD RESEARCHER RECORD-KEEPING RESPONSIBILITIES

The Office of Research Administration is the office of record for the UCI Animal Care and Use Program. However, the IACUC Administrative staff is not responsible for maintaining study documents for the researchers, or for providing copies of official documents to research staff. Lead Researchers are responsible for keeping accurate and complete protocol records, and for ensuring that all members of the laboratory staff are familiar with the protocol and all approved procedures.

The following guidelines are provided to assist investigators and research staff with recordkeeping of approved IACUC protocol documents and to facilitate submissions of correct versions of protocol documents during each three-year approval period and throughout the entire study.

ONGOING PROTOCOL MAINTENANCE


Annual Continuation:
While a de-novo review by the IACUC is required every three years, all protocols require annual renewal. To maintain protocol approval, an Annual Continuation Application must be submitted for continued approval of years two (2) and three (3) of the protocol. An IACUC subcommittee (administrative review and Chair approval) reviews annual continuation applications.

Expired Protocols:
The approval to use animals in research, testing, and teaching expires on the date of protocol expiration if a renewal application (annual continuation or three-year renewal, as applicable) has not been approved.

Federal regulations require that all experimental use or observation of animals must cease on the expiration date and may not resume until IACUC approval is restored. If a protocol lapses in approval, animals are moved to the ULAR holding protocol and are off limits to investigators and research personnel. Failure to act in accordance with this restriction will be treated as regulatory noncompliance.

Modifications:
All protocol modifications (e.g., a change in procedure, animal numbers, personnel, room locations) require IACUC review and approval before implementation of the changes. No changes to approved IACUC protocols may be implemented before IACUC approval is obtained. The IACUC modification cover sheet and instructions are on the IACUC website. Additional information is provided in the modification instructions and on the IACUC website. Many factors contribute to the level of review a protocol modification receives from the IACUC. Consultation with a ULAR Veterinarian and the IACUC Administrator is recommended before submission.

Reporting of Animal Numbers:
All animals purchased through ULAR Purchasing are automatically counted against a protocol’s approved allocation. However, animals that are born at UCI, as well as some species that are not subject to ULAR purchasing procedures, are not captured automatically in the animal system database. It is the responsibility of Lead Researchers and their staff to ensure that all animals used or produced under approved protocols are accurately counted for reporting to federal agencies.

The following categories of animals must be reported via the Web Reporting of Animals Interface:


Part 3: Completing the Application for IACUC Review

The application is designed to obtain specific information required by animal welfare regulations and UCI policies. Specific instructions, suggestions, and references for completing each section of the application and protocol narrative are provided below.

General Guidelines for Application Preparation:

A. Title of Study

Please provide a title for the research described in the application. This title will be linked with the protocol number assigned by the Office of Research Administration for all protocol-related correspondence.

B. Lead Researcher

Lead Researchers who do not meet the criteria to serve as Principal Investigators, as defined by UCI policy, must have a Faculty Sponsor who is eligible to serve as a Principal Investigator.

C. Faculty Sponsor Requirements

Lead Researchers who do not meet the criteria to serve as Principal Investigators, as defined by UCI policy, must have appoint a Faculty Sponsor who is eligible on his/her own to serve as a Principal Investigator.

D. Alternative Lab Emergency Contact Person

Someone from the laboratory must be available at all times to make decisions regarding treatment or euthanasia of animals in pain, distress or discomfort. A qualified individual other that the Lead Researcher must be listed in the event that the Lead Researcher cannot be reached by University Laboratory Animal Resources (ULAR) . Both the Lead Researcher and the Emergency Contact Person must provide an after-hours telephone number such as their home phone, cellular phone or pager.

NOTE: In the event of an emergency, every effort will be made to reach the designated person (Lead Researcher or other emergency contact individual); however, if animals are found to be in pain and/or distress and no one can be reached the animals will be treated appropriately by Veterinary Services.

E. Administrative Contact Person

(Optional) An administrative contact may be listed in this section if the Lead Researcher would like to have another individual receive copies of protocol correspondence such as protocol renewal notices and requests for additional information to secure protocol approval. The Administrative Contact Person does not need to complete the online animal tutorial if he/she will not be involved with their use.

F. Study Team Members

List all personnel with animal contact in this section. Only those individuals listed in this section will be authorized to handle animals when IACUC approval is granted. Be sure to include any collaborating faculty, postdoctoral fellows, technical and research staff, graduate and undergraduate students who will handle live animals. Include each person’s email address and their name as it appears in university records.

G. Study Funding and Scientific Merit Review

Indicate how the study costs will be supported. Information in this section is used to link extramural awards to the applicable regulatory approvals. Please check all of the applicable boxes as funding sources for this research, including any pending sources. List all extramural proposals or awards that will support the study as applicable.

Completing the table for extramural funding sources:

H. Procedures to be Performed in Live Animals

Enter the name of each species to be used at the top of the table where indicated, and check all applicable procedures that will be performed for each species. All species listed in Section 4 of the protocol narrative must be listed here as well. These categories are used to generate reports from the IACUC database for annual reporting to federal agencies. NOTE: Some procedures are associated with a required appendix.

Important: Please review and complete this section carefully. Many of the required appendices for IACUC submission are included in this section.

Notes:

I. Animal Housing and Procedure Locations

Animal Locations: List all location(s) where animals will be housed and/or used. Exact room numbers should be indicated for all laboratory locations outside of ULAR-maintained vivaria; however, all rooms within ULAR-maintained vivaria may be listed simply by the Building Name and “vivarium” as the room number. All specific vivarium housing and procedure rooms are assigned by ULAR.

Animal Husbandry and Housing: Any deviation from standard ULAR-staff-provided husbandry and care of animals within UCI vivaria space requires completion of the appropriate appendix.

Important: Please review and complete this section carefully. Many of the required appendices for IACUC submission are included in this section. Appendix H, “Non-UCI Research/Housing Locations” is required for any live-animal procedures or housing that will take place at any non-UCI site (e.g., another university, private company, etc.)

J. Departmental or Organized Research Unit Approval

If the study will be performed under the auspices of a Department (includes campus centers and school-based research units) the Department Chair of the Lead Researcher (or the Faculty Sponsor when applicable) must read and sign the protocol indicating approval before IACUC review may occur.

Notes:


Part 4: Completing the Protocol Narrative IACUC Review

Section 1: Project Overview

Provide a brief overview of the research, testing or teaching project. State the overall objectives and the relevance (e.g., benefits) to human or animal health, advancement of knowledge, and/or the good of society. This section is sometimes used by the UCI Communications Office for publicity regarding campus researchers and their work. It must be written in language understandable to the lay public; it is recommended that you assume those assessing your application have either no medical scientific background or no knowledge of your area of research.

The following is an example of a good lay summary:

“This project is focused on understanding how bacterial infections of the small intestine are inhibited in healthy individuals. A highly specialized intestinal cell, the Paneth cell, contributes to a biochemical barrier against infection by releasing natural antibiotic substances, including á-defensins, into the small intestine. In addition, Paneth cells secrete additional products that may protect against colonization of the small intestine by bacteria and prevent bacteria from crossing over into the blood stream. We have reported that mouse Paneth cells release defensins actively when triggered by bacteria and bacterial cell components. For the most part, however, the role and function of Paneth cells in immunity is poorly understood. Paneth cells have become specialized to the point that they cannot be stimulated to make new DNA and divide; therefore, no Paneth cell lines exist, and we are required to work with primary cells isolated directly from mice.

Our goals are to (a) understand the cell components and the events that allow mouse Paneth cells to sense bacteria and secrete defensins that kill them; (b) define the biochemical constituents of mouse Paneth cell secretory granules; (c) understand the molecular details of how inactive defensin precursor molecules become activated to their functional forms in mouse Paneth cells; and (d) investigate the persistence of defensins after secretion by Paneth cells by testing for and characterizing defensins present in mouse colonic and rectal tissue. That knowledge will advance the understanding of host defense mechanisms in the small intestine and in epithelial cells in general.”


Section 2: Justification for the Use of Animals

A. Rationale for the Use of Animals

Two distinct parts are required to properly answer this question:

  1. You must provide a scientific rationale for the use of live vertebrate animals. This should include a discussion of why in-vitro experiments, computer modeling or other methods cannot be used.
  2. You must also indicate why the proposed species is the most appropriate for the research project. If more than one species or multiple strains of the same species are proposed, you must provide a separate scientific justification for each species/strain and an explanation for why experiments must be repeated in different species/strains.

Notes:

B. Consideration of Alternatives to Live Animal Use, Painful Procedures, and Unnecessary Duplication

A fundamental goal of the Animal Welfare Act (AWA) and federal regulations and policies is the implementation of the “Three Rs” of laboratory animal use:

Obviously, potential “alternatives” that do not allow the attainment of the goals of the research are not, by definition, alternatives. Similarly, a reduction in the number of animals should not be made if it results in an increase in the level of pain, distress or discomfort in individual animals (e.g., multiple survival surgeries).

The IACUC is required to review this information in order to assure that researchers have made a reasonable and good faith effort to determine the availability of alternatives or alternative methods.

The USDA considers the performance of a scientific literature database search to be the most effective and efficient method for demonstrating compliance with the requirement to consider alternatives. IACUC policy requires that at least two such databases be searched, and the searches need to be carefully documented in the protocol application; items 1 – 4 in this section are designed to guide you in preparing the appropriate documentation.

Keywords used in the database searches should be chosen carefully, and must be representative of the model and methods proposed in the protocol.

In some circumstances (as in highly specialized fields of study), conferences, colloquia, subject expert consultants or other sources may provide relevant, up to date information regarding alternatives in lieu of, or in addition to a database search. If such an alternative is used as a means of considering alternatives, sufficient documentation, including the consultant’s name, qualifications and the date and content of the consult must be provided in item #5 to provide documentation for the consult.

Narrative Description (Item #6): Please complete this section for all protocols, regardless of the proposed procedures.

Assistance with Alternative Searches:


Section 3: Experimental Design

Federal regulations require that the IACUC review the number of animals requested in each protocol and assess whether the number is appropriately justified in terms of the stated goals of the project. Therefore, all protocols must begin with a clear statement of the hypothesis being tested and/or the rationale for each experiment to be performed. The structure of this section will vary depending on the nature of the study; the five questions in the shaded section of the application are designed to guide you in providing the information necessary for the IACUC to adequately evaluate the experimental design and the justification of animal use. Please provide the information requested in these five questions for each proposed experiment.

Suggestions for Completing this Section:

Section 4: Animal Requirements and USDA Pain Categories

Condition Code refers to the general categories of animals with reference to age, genetic alternations, reproductive status, etc. and are used for animal purchase, transfer, and reporting of animal numbers used back to ULAR. Condition codes pertain primarily to rodents. There are eight (8) possible condition codes:

Code Description of the Code
Adult Inbred, outbred and F1 hybrid strains at least 21 days old (weaned).
Pregnant Animals purchased, shipped and/or used for research while they are pregnant.
Dam with Litter (DWL) Nursing mother purchased and shipped with her litter of pre-weanling pups.
Pup Animals purchased or used for research before they are weaned (21 days for rodents).
Adult-S
  • Genetically altered animals (transgenic, knockout)
  • Animals surgically altered by the vendor (e.g., adrenalectomy, ovariectomy)
  • Diabetic or spontaneously obese animals
  • Immunocompromised animals
Pregnant-S See Adult-S
DWL-S See Adult-S
Pup-S See Adult-S

USDA Pain and Distress Category

The United States Department of Agriculture has defined four specific categories in which animals must be separated for reporting purpose with regard to the expected pain, distress and discomfort they will experience as research animals. Using the definitions below, assign a USDA pain and distress category for each species according to the procedure the animal will undergo.

Definitions

USDA Category “B” Animals are held only for the purpose of producing offspring or establishing and maintaining a breeding colony. Animals in this category will not be used for any research, teaching or testing purposes. Pups that will be culled from litters prior to weaning, pregnant animals that will be allowed to give birth naturally, and dams with litter where the pups will be used for research but the dam is not used should all be categorized in “B.”

USDA category “C” Animals are used in procedures that produce minimal, transient, or no pain or distress greater than that from routine injections or venipuncture. Animals that are humanely euthanized by any method for the purpose of tissue harvest should be categorized in “C”, as well as animals that undergo any procedure involving no more pain or distress than that associated with a needle stick.

USDA Category “D” Animals that are used in procedures that would be considered painful and/or distressful to a human, but are performed using appropriate anesthetics, analgesics, sedatives or tranquilizers for alleviation or prevention of pain and distress. Animals that undergo any invasive procedure, including cardiac perfusion or exsanguination, under anesthesia should be categorized in “D”.

USDA Category “E” Animals that are used in procedures expected to cause pain and/or distress in a human, which cannot be performed using anesthetics, analgesics or tranquilizers without adversely affecting the study. Animals used in any procedures for which needed analgesics or anesthetics must be withheld for justifiable study purposes or that undergo a disease process that will be allowed to progress to a moribund state must be categorized in “E”; prolonged mechanical or physical restraint may be considered a category “E” procedure, depending upon duration and type of restraint. Other examples include (but are not limited to) application of noxious stimuli (e.g., electric shock) which the animal cannot escape, infliction of burns or trauma, exposure to extreme environmental conditions, and euthanasia by procedures not approved by the AVMA. Approval to conduct category “E” studies requires strong scientific justification (see below) and must be reported to the USDA in UCI’s annual report, which is available to the public.

Veterinary consultation is strongly recommended for all studies involving Category D or E procedures. If Category E procedures are proposed, you must provide a scientific justification in the space provided at the end of Section 4.

Justification for Animals in Category E

The following conditions require strong written scientific justification with particular attention to significance, necessity, and potential benefits of the research in order to be performed. Investigators must perform euthanasia on all moribund experimental animals unless there is scientific justification that euthanasia would invalidate experimental data collection. If euthanizing a moribund animal would seriously harm the study, the scientific justification for using death as an endpoint must be provided.

Definitions:

Death as an endpoint refers to projects in which the animals’ non-experimentally induced death is required as a measured data point. It does not refer to projects in which the animals will be euthanized prior to non-experimentally induced death for tissue collection or project termination.

Moribund is defined as “in a dying state.” Animals are considered moribund if they evidence unconsciousness or show no response to external stimuli such as a toe pinch withdrawal test.

Consultation with a ULAR veterinarian regarding alternative endpoints is required. Below is a listing of alternative endpoints that should be considered:


Section 5: Description of Non-Surgical Procedures

Describe in detail all of the non-surgical procedures to be performed on live animals.

  1. Euthanasia followed by Tissue Harvest: Briefly describe the tissues or organs that will be removed once the animal is confirmed dead by the euthanasia method described in Section 10.
  2. Blood and Tissue Collection in Live Animals:
    • Indicate the site on the animal and the method for collection (e.g., tail vein, size of needle)
    • Indicate the quantity of blood/tissue collected and the frequency of the collection
    • Describe how animals will be restrained for the procedure. Include the duration of the restraint.
    • If anesthesia will be used, describe it in item #4 (see below).
    • The IACUC guidelines for blood collection must be followed.
  3. Behavioral Studies:
    • Describe all behavioral testing to be used and the duration of the testing.
    • Describe any experimental stimuli that will be presented to the animals.
    • Describe any sensory or dietary deprivation to be used.
    • Describe how animals will be monitored during the behavioral study.
    • Discuss the use of any restraining devices. Include the duration of the restraint. If anesthesia will be used, describe in item #4 (see below).
  4. Administration of Experimental Agents:
    • Indicate the site on the animal and the method of administration (e.g., tail vein, .22 gauge needle)
    • Indicate the number of administrations and the duration between administrations, if applicable.
    • Experimental agents include drugs, placebos, viruses and other biological agents, tumor cells, gene markers, tracers, radioisotopes, etc.
    • The use of biological or potentially hazardous agents in live animals may require special handling to protect animal welfare and worker safety. Researchers must complete Appendix C for all potentially hazardous agents.
    • Biological materials of rodent origin require pathogen testing prior to use.
  5. Induction of Anesthesia/Sedation for Non-Surgical Procedures: Provide the requested information if anesthesia and/or sedation will be used for any non-surgical procedure, such as imaging, blood collection, or restraint.
  6. Imaging Procedures:
    • Describe the procedure to be used and the duration (and frequency if applicable).
    • Discuss the use of any anesthetics or restraining devices.
    • Describe how animals will be monitored during the imaging,
    • Examples of imaging include x-rays, MRI and PET scans, optical imaging, etc.
  7. Cardiac Perfusion:
    • This subpart must be completed if cardiac perfusion or cardiac puncture procedures are performed in deeply anesthetized animals (i.e., respiration is present at the time of blood collection.)
    • Note: If respiration is not present at the time of collection, this procedure should be described in Section 9, Euthanasia Methods.
    • Describe the procedure, including the use of anesthesia and how depth of anesthesia is assessed prior to performing the procedure.
    • All deeply anesthetized animals undergoing cardiac perfusion or cardiac puncture are categorized in USDA Pain Category D.
  8. Other Nonsurgical Procedures:
    • Provide a description of any other non-surgical procedures used for live animals, such as laser or optical treatments, irradiation, experimental devices, or use of other equipment.
    • Breeding of animals for research should not be described here. If animals will be bred at UCI for this protocol, please complete and attach Appendix B.
  9. Post-procedural Care (as applicable): Describe how animals will be monitored during the recovery period after the non-surgical procedures described above. Include recovery from anesthesia or sedation as applicable. Long-term care and monitoring of animals should be described in Section 7.

Section 6: Description of Surgical Procedures

Describe in detail all terminal or survival surgeries that will be performed on live animals.

General Requirements:

Surgical Records and SOPs:

  1. Pre-operative Care
    • Indicate how long animals will be allowed to acclimate in the vivarium after arrival from the vendor prior to surgical procedures. ULAR policy requires a minimum of 48 hours acclimation period for rodents and 72 hours for larger species.
    • If fasting is required before surgery, indicate the length of the fasting period and whether water will be available to the animals during the fasting period. Not all species require pre-surgical fasting - consultation with ULAR veterinary staff is recommended.
  2. Induction of Anesthesia for Surgical Purposes
    • Answer all questions as they apply to the anesthesia required for surgical procedures.
    • Describe pre-surgical sedation and any other procedures that will be performed prior to induction of anesthesia.
  3. Aseptic Techniques
    Terminal Surgery: All terminal surgery should be performed using “clean technique” (i.e., designated area for surgery, clean instruments and appropriate attire for surgeon).
    Survival surgery: All survival surgery must be performed using aseptic technique. Aseptic technique encompasses a number of practices and procedures to reduce microbial contamination of surgical sites to the lowest practical level. In general, survival surgical procedures should be performed using the same aseptic practices common in veterinary and human medicine.

    Preparation of the Surgical Space
    • Surgical areas must be maintained and operated in a manner that ensures cleanliness and minimizes unnecessary traffic.
    • For non-rodent mammalian species (e.g. rabbits, dogs, non-human primates, etc.), surgery must be performed in an area specifically designated for that purpose, i.e., a surgical suite. This area is typically divided into several functional areas: animal preparation, surgeon’s scrub, operating room and postoperative recovery.
    Preparation of the surgeon
    • Use of surgical scrub/hand washing
    • Use of surgical attire: mask, sterile gloves, gown and cap
    Preparation of the animal(s)
    • Removal of hair from the surgical area
    • Cleansing and disinfection of the skin
    • use of surgical drapes
    Sterilization of instruments: Indicate how instruments will be sterilized prior to use. If surgeries on multiple animals will be performed during the session, describe how instruments will be cleaned and sterilized between animals.
    • Steam (autoclave)
    • Dry heat (e.g., hot bead sterilizer)
    • Ethylene oxide
    • Chemical sterilants (Alcohol is not a sterilant)
  4. Surgical procedure
    • Describe in detail the surgical procedure to be performed.
    • If more than one surgical procedure will be performed as part of the project, describe them separately and label them accordingly (e.g., “(a) Survival Surgery; (b) Terminal Surgery.”)
  5. Methods to prevent dehydration & hypothermia
    • Describe the type and volume of supplemental fluids to be administered during the surgery. Include the rate of infusion if appropriate.
    • Describe the how animals will be kept warm during and immediately after the surgery (until recovery from anesthesia).
  6. Surgical Endpoints and Post-operative Care Describe how animals will be monitored during the immediate recovery period following each survival surgical procedure. Include details of how animals will be monitored while recovering from anesthesia. Long-term care and monitoring of animals should be described in Section 7.
    • Indicate the approximate length of each surgical procedure
    • Indicate the final disposition of the animal after the surgery (e.g., animals are recovered, animals are euthanized)
    • For survival procedures, describe how animals are monitored for recovery from anesthesia and when animals are returned to their home cages.
    • Immediate post-surgical care minimally includes the following:
      • Continuous observation to ensure uneventful recovery from anesthesia
      • Provision of supplemental heat during anesthetic recovery
      • Administration of fluids and other medications as needed
    • Post-Surgical Analgesia: UCI IACUC policy requires the use of post-surgical analgesics unless a strong scientific justification is provided for withholding them. Consultation with campus veterinary staff is strongly recommended.

Section 7: Adverse Effects & Animal Monitoring and Management

Adverse Effects include any reaction, expected or unexpected, that may occur in the animals as a result of any experimental procedure or manipulation. Examples include drug toxicity, injury, surgical wounds, lameness, lethargy, anorexia, tumors, etc. Phenotypic Abnormalities are specifically associated with genetically-altered animals, and may include neurological deficits, tendency to develop a particular disease, reduced immune response, etc. Both adverse effects and phenotypic abnormalities may result in the potential for pain, distress and discomfort.

Clinical Signs are the actual symptoms that may occur in the animals to indicate that an experimentally-induced adverse effect may be underway. Clinical signs may include frank disease development such as ascites or tumor growth, lack of appetite, lack of normal grooming behavior, abnormal shyness or lethargy, excessive weight loss, abnormal posture, licking or biting of the wound area, etc. An understanding of normal species-specific behavior is crucial in evaluating potential abnormal clinical signs.

Monitoring Parameters are the clinical signs that should be watched for in animals, to indicate that an animal may be experiencing an adverse effect or phenotypic abnormality. All members of the research team should be familiar with the signs and symptoms of pain, distress and discomfort in the animals.

Management Plan is the detailed course of action for post-procedural care and monitoring of the animals. The plan must, at minimum, include:

Frequency of Monitoring: Indicate how often members of the study team will visit the housing rooms and visually inspect the animals for clinical signs of pain, distress or discomfort. Daily monitoring is recommended for most animals; some procedures require more frequent monitoring.

Criteria for Euthanasia
Describe in detail the criteria for euthanasia of animals (examples include loss of weight/mobility, failure to groom, abnormal posture, licking/biting wound area, etc.) Refer to the IACUC Euthanasia Policy for more information.

Important Notes:


Section 8: Experimental Drugs/Agents and Therapeutic Drugs

List all experimental drugs/agents and therapeutic drugs that are described in Sections 3, 5, 6 and 7 of the application.

All therapeutic agents, drugs and medical materials (e.g., sutures) intended for use in live animals may not be used beyond the expiration date printed on the package by the manufacturer and should be either discarded or clearly labeled “Not for Use in Live Animals.” For more information, please review the IACUC Policy for Use of Expired Drugs and Medical Materials.

Controlled substances include commonly used anesthetics such as ketamine, buprenorphine, and sodium pentobarbital. Controlled substances must be stored under double lock – that is, in a securely locked cabinet or safe within a laboratory or office that can also be locked when responsible laboratory personnel are not present. For more information about whether a drug is controlled by the DEA and/or the State of California, or how to properly log controlled substances, please review Use of Controlled Substances in Animals or contact EH&S.


Section 9: Euthanasia Methods

Indicate the method of euthanasia for each species to be used. Researchers must review the IACUC Policy for Euthanasia of Research Animals before completing this section.

Euthanasia methods must be identified as Acceptable or Conditionally Acceptable by the American Veterinary Medical Association. Use of Conditionally Acceptable methods require scientific justification.

All members of the research team should be familiar the euthanasia method(s) to be used. Training is available from Veterinary Services.

Anesthetic Overdose:

Physical Methods

Confirming death in euthanized animals:


Section 10: Roles, Responsibilities and Experience of the Study Team

The study team includes the Lead Researcher, Faculty Sponsor (if required), all co-investigators, and any other research personnel who will perform research procedures and/or care for the animals involved in the research.

If a study team member does not have relevant experience or training for a particular species or procedure they will perform, a description of how they will be trained must be provided.

Information about acceptable training for inexperienced personnel is available on the IACUC website. ULAR staff also offer regularly scheduled training courses.


Part 5: Completing the Appendices for IACUC Review

Appendix A - Three-Year Progress Report

Complete this appendix if the application is for three-year de novo review of an ongoing project.

Note: The IACUC must take into account changes or updates in the federal regulations that pertain to animal research; changes in the interpretation or application of those regulations; and changes in societal views regarding animals in research. Investigators are advised to review each section of the new application carefully to prevent oversights of information required for approval.

Appendix B - Create and Maintain a Breeding Colony

Complete this appendix if you intend to establish and maintain a breeding colony of transgenic rodents. This form is not required for use of pregnant animals obtained from commercial vendors.

Responsible Individual/Research Personnel: A person who has responsibility for the animals in the breeding colony must be available by telephone at all times in case of an emergency. Veterinary Services will make every attempt to reach the designated person (Lead Researcher or other responsible individual); however, if animals are found to be in pain and/or distress and no one can be reached, the animals will be appropriately treated by Veterinary Services.

List all other members of the research team who will participate directly in the care and maintenance of the colony.

Scientific Justification: Provide a scientific justification for establishing and maintaining a breeding colony of animals at UCI. Include the following information in the justification:

Reporting and Record-Keeping: Investigators and research staff are responsible for keeping records pertaining to the health and maintenance of the breeding colony. Please review the IACUC guidance for maintenance of breeding guidelines on the IACUC website. The minimal record keeping requirements include:

  1. The species and strain designation (e.g., C57BLI6J, B6D2F1, etc.)
  2. All phenotypes and genotypes
  3. Breeder identification numbers (each breeding animal should have a unique identifier that is not repeated in subsequent generations)
  4. Set-up date (mating date)
  5. Breeder date of birth (DOB)
  6. An accounting of all colony offspring including:
    • Animals weaned and retained for colony maintenance
    • Animals used for research
    • Culled littermates (e.g., undesired genotype)

Most investigators devise their own record-keeping methods; many use commercial spreadsheet software such as Microsoft Excel.®

Researchers are responsible for the periodic reporting of animals that are obtained from UCI breeding colonies. Animals produced in breeding colonies must be reported via the web interface at least once per year for inclusion in UCI’s annual reports. It is recommended that investigators report animals on a more frequent basis, such as quarterly or every six months.

Appendix C - Hazardous Agents Used in Live Animals

This form must be completed if hazardous agents will be used in live animals. Consultation with campus veterinarians and Environmental Health and Safety personnel prior to completion of this form is strongly recommended.

Potentially hazardous agents include (but are not limited to):

Provide the protocol numbers and approval periods for all applicable regulatory committee and campus approvals. This information is used to link corresponding approvals to the research described in the application.

IBC and IRB protocols: If your research project involves the use of recombinant DNA, Institutional Biosafety Committee (IBC) approval is required before IACUC approval will be granted. If your research project involves the use of human specimens (e.g., primary cells, sera, tissue, etc.) that require registration or approval from the Institutional Review Board (IRB), please list your protocol number and approval period. If you have not received a regulatory committee approval, please indicate the status of the protocol review (e.g., protocol review date).

EH&S Biological Use Authorization (BUA): If your research involves the use of etiologic / infectious agents, vectors, toxins, humans, sheep, non-human primates, or their source materials, you must have a BUA approved by EH&S before beginning laboratory research. For more information about the BUA program and other services provided by the Office of Environmental Health and Safety (EH&S), including the radiation safety committee, visit the EH&S website or contact the Campus Biosafety Officer.

Sheila Hedayati
Campus Biosafety Officer
(949) 824-9888
s.hedayati@uci.edu

Notes:

Appendix D - Use of Prolonged Restraint

This appendix must be completed if animals will be physically restrained in any way and for any length of time that could reasonably be considered distressful.

Appendix E - Use of Paralytic Agents

This appendix must be completed for any use of a paralytic or neuromuscular blocking agent.

Appendix F - Multiple Major Survival Surgery

Complete this appendix if more than one invasive survival surgical procedure will be performed on individual animals.

A scientific justification must be provided for performing multiple survival surgery on a single animal. The reduction in the number of animals needed as a result of performing multiple surgeries on individual animals must be weighed against the possible increase of each animal’s experience pain, distress or discomfort. Review the appropriate IACUC policies (Multiple Major Survival Surgery and Oocyte Removal) for more information and guidance.

Appendix G - Production of Monoclonal and Polyclonal Antibodies

Complete this appendix if antibodies will be produced in live animals. Use of commercial antibody laboratories for the production of custom antibodies is recommended.

Appendix H - Non-UCI Research/Housing Locations

Complete this appendix if animals will be housed or used at any non-UCI-controlled locations. This includes situations where animals will be transported to another location (e.g., a collaborator’s lab on another university campus) for a procedure but will remain the sole property of UCI. It does not apply when the ownership of the animals is transferred to another institution.

Appendix I - Investigator-Maintained Animals

This appendix is required when:

Once completed, Appendix I serves as the Standard Operating Procedure for investigator maintenance of research animals. ULAR staff can assist investigators in the development of cleaning and husbandry SOPs.

Appendix J - Request for Housing Exception

This appendix must be completed if animals will be held outside of the vivarium for longer than 12 hours. It does not need to be completed if animals are brought to the laboratory for a procedure and then returned to the vivarium housing room on the same day (less than 12 hours out of the vivarium).

NOTE: If animals will be housed in the laboratory or other area for more than 24 hours, investigators must also complete Appendix I in order to describe how animals will cared for while outside of the ULAR-controlled vivarium.

Investigators and their staff are responsible for monitoring and assessing the condition and health of all animals held outside the vivarium. Animals must be assessed on at least on a daily basis, including weekends and holidays.

Appendix K - Variations in Standard Housing And/Or Husbandry

This appendix must be completed if any variation from standard ULAR-provided husbandry, care and feeding of the animals is proposed. Examples of variations include:

Notes: