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Instructions for the IACUC Animal Use Protocol Application

 

 

IMPORTANT NOTICE

All researchers, students, technicians etc. listed on existing IACUC-approved protocols, including PIs, must complete the new CITI Animal Care and Use training (details below) by November 1, 2013 to maintain an active protocol.  If personnel listed on a protocol, including the PI, fail to complete the training, the protocol shall be suspended until training by all protocol personnel has been completed. CITI Training is available at:

 

https://www.citiprogram.org/

 

In addition, beginning on August 6, 2013, CITI Animal Care and Use training will be required for all PIs and project personnel on all new research protocols before protocols can be approved.  Any new personnel added to a project must complete the CITI Animal Care and Use training before the protocol modification is approved.

Field and Observation (Classroom Protocols) are exempt.

Please contact Mary Walker (Mary.Walker@csulb.edu, 5-5314) if you have any questions.

 

Submission of Application

  1. The Attending Veterinarian of CSU Long Beach must be consulted in the desing of your study. Fill out the form and send it as an attachment to the Attending Veterinarian, Dr. John Young. Do not answer questions by referencing related grants or other documents. Answer each question concisely. Copy Mary.Walker@csulb.edu on the email to the Attending Veterinarian and all subsequent correspondence.
  2. In addition, download the "Investigator Assurance of Compliance with CSU Long Beach Guiding Principles and Policies Governing the Use of Animals in Research" form, sign, and send it to the Research Office (Mary.Walker@csulb.edu) , which will be kept on file. This form only needs to be submitted to the Research Office once. Contact the Research Office if you are unsure that you have an Assurance on file.

In compliance with the USDA Animal Welfare Act regulations, Public Health Service Policies, and Association for the Assessment and Accreditation of Laboratory Animal Care International standards, the CSULB Institutional Animal Care and Use Committee (IACUC) is required to review and approve, require revisions in (to secure approval), or, if appropriate, withhold approval of proposed activities related to the care and use of animals at CSU Long Beach.

Applications must be reviewed and approved by the IACUC before any animals can be ordered, procured, or used. In some cases, sponsoring agencies require documentation of approval before an award is made. The IACUC only approves activities involving the use of animals for one year at a time. When the entire project period exceeds one year, an annual review of the activities by the IACUC is accomplished through submission of an Annual Report Form. This form will be sent to the Principal Investigator by the Office of University Research prior to the expiration of the approved period.

Page One

  • Project Title: If there is a grant or contract that corresponds with this IACUC Application, the project title should be the same as that of the grant or contract. If this is a subproject of a larger grant, list the grant title and the subproject title.
  • Project Dates: Indicate the date that you desire this approval to begin. The start date should be the same as the anticipated start dated of the corresponding grant and/or contract, and must be within one year of submitting this Application to the Research Office. Regarding the end date, the entire duration of the project cannot exceed three years.
  • Funding Source: If funded, indicate funding source.
  • Name of the Principal Investigator (PI): There can be only one PI of record. The PI must be the person listed on the grant or contract that corresponds with this IACUC Application.
  • Department: List the building and room number where the Research Office staff can mail official correspondence regarding the IACUC Application.
  • Extension, Email and Fax: List the campus phone number, email address, and fax number that the Research Office staff can use to contact the PI regarding the IACUC Application.
  • At the completion of the IACUC review process, prior to activation of the protocol, an original signature will be asked of the PI.

Back to Application

  1. Project Type

    • This section is intended to give the IACUC a concise overview of the reasons for proposing the research, the nature of the procedures to be performed on animals, and the expected results.
  2. Project Summary

    1. Rationale and Significance: Explain how the results of this project can be expected to add to the body of scientific knowledge and/or positively impact health care of humans and/or animals? If applicable, include in this section how many people suffer from the condition/illness that your research work is trying to address.  "Lay" language should be used, and if technical terms are used, they should be defined in lay language in section III.C.
    2. Procedures: Chronologically outline all procedures to be performed on live animals in a brief, step-by-step description. Do not include drug dosages, animal numbers, or other details provided elsewhere. This summary should be detailed enough to allow the reader to form a mental image of all procedures a single animal undergoes in chronological order. "Lay" language should be used, and if technical terms are used, they should be defined in lay language in section III.C.
    3. Definitions: If technical terms are used in II.A and/or II.B, explain the terms in language that an intelligent, non-medical person can understand.

Back to Application

  1. Personnel Qualifications

    1. Fill out this section for each individual (including students) directly involved with the animal procedures in this protocol.
      • Check all activities each individual will be performing: anesthesia, surgery, non-surgical procedures, and euthanasia. List the qualifications and training specific to the species and methods proposed in this Application on the line following each "activity" box checked. Include the degree of experience for each individual.
      • If individuals have no appropriate training or experience, name the person(s) who will train them. If training by the veterinary staff is desired, state so.
    2. At least one of the people listed in III.A must be named to be contacted in case of an animal health emergency. This includes evenings, weekends, and holidays.

Back to Application

  1. Justification for Use of Proposed Animal Model

    • Investigators are required by federal regulations to provide a description of the methods and sources of information used to determine that alternatives to the proposed animal model and procedures are not appropriate.
    • The term "alternatives" refers to the 3 R's - Reduction, Refinement, and Replacement:   Reduction of animals to be used to the minimum number necessary to reach meaningful results; Refinement of biomethodology to produce the least amount of stress and/or pain in the animals; Replacement of animals higher on the evolutionary (phylogenetic) scale with lower animals, and/or replacement of animals with such procedures as tissue cultures, computer simulations, etc.
    1. A database search is required. Check all sources or methods used.
    2. Consider the following in answering yes or no to the questions in IV.B:
      1. Would it be ethical to consider the use of humans for this project?
      2. Is the software available to make this work possiblewith computers? Have adequate parameters been established to utilize computer simulation for this project?
      3. Could established or primary cells be used?
    3. The following written, narrative assurance is required by federal regulations:
      • "I have performed a database search on (insert date), covering the years (insert years searched), using the above named sources and keywords. Based on (insert number) of years of experience in this field, in conjunction with attendance at meetings and personal communications with my colleagues, I believe that (1) the procedures I have chosen represent the best alternative to performing this work; (2) that the (insert species) animal model is the most appropriate for conducting my work; and (3) that the proposed studies do not unnecessarily duplicate the work of any other groups in my field."

Back to Application

  1. Description of Animal Subjects

    • A - G. If you have questions about how to answer these sections, contact the Consulting Veterinarian 310-423-7684, fax 310-423-0290, john.young@cshs.org.
    1. Provide the required information.
    2. "Special" needs include such things as accessing animals during the customary quarantine period, unique diet or water requirements, unique photoperiods, individual housing of animals, breeding of animals, need for containment for hazardous agents, access to animals during off-hours, transport of animals outside of research facilities, etc.

Back to Application

  1. Description of Surgical Procedures

    1. For the purposes of this Application, "Surgery" is defined as any procedure that involves an incision. Note: injections, blood collection, or euthanasia procedures alone are not surgery.
    2. All major survival surgical procedures in non-rodent species ( FYI - rabbits are not rodents), must be performed in designated surgical facilities.
    3. Definition of aseptic technique - minimum criteria:
      • Rodent Species
        • Clipping of hair from incision site and application of a betadyne preparation ("prep") to the skin.
        • Use of sterile instruments (for rodents, cold sterilization is acceptable. NOTE: isopropyl alcohol is not a cold sterilant.)
        • Use of examination gloves. Certain rodent surgical procedures (organ transplants, for example) require more strict aseptic techniques including wearing of surgical gloves, cap and mask, and/or draping of the surgical field.
      • Non-Rodent Mammals (e.g., rabbits)
        • All of the above techniques apply, plus the following:>
        • Use of sterile instruments (sterilized via autoclave).
        • Use of surgical (not exam) gloves, cap, mask, and gown.
    4. If the protocol calls for two surgeries, one survival and the second non-survival, in answer to "Is the surgery survival?" check "YES" and qualify your answer by adding: "First Surgery." Then in answer to "Is the surgery non-survival?" check "YES" and qualify your answer by adding: "Second Surgery."

      Although it is discouraged, the IACUC can approve multiple survival surgical procedures in the same animal, if justified on a scientific basis. Economics or cost savings are not acceptable justifications.

    5. In your chronological description of presurgical and surgical procedures include the following: fasting (duration), preoperative sedatives/tranquilizers (agent, dosage, and route), preoperative antibiotics (agent, dosage, and route), anesthetics (agent, dosage, and route), surgical site preparation, site of incision, surgical manipulations, and method of wound closure.

      If different surgical protocols are used for different groups of animals, specify the procedures for each group chronologically.

      If investigational medications, chemicals, devices, etc., are employed during the surgical procedures or during anesthesia for surgery, list them under Section VI.G.
  1. 1 & F.2. Self-explanatory
  1. 3. Supportive care always includes observation of the animal until recovery from anesthesia. Additionally, supportive care can include monitoring temperature, pulse, and respiration; providing supplemental heat and/or fluids; administration of analgesics and/or antibiotics; and observation of incisions.
  1. 4. If good aseptic technique is employed, and the surgical site is not a source of contamination (i.e., the gastrointestinal tract), prophylactic antibiotics are not indicated.
    • Regarding administration of analgesics, the general guideline is: if a human undergoing a similar surgical procedure would benefit from analgesic treatment, then you should assume that the animal would also. In these instances, analgesia should be administered to the animal. Many animals, such as rodents, will not show that they are in pain. Indications of stress and pain are species specific.
  1. Chemicals, agents, devices, medications, etc., employed or evaluated during surgical procedures (NOTE: Non- experimental (routine) anesthetics, sedatives or tranquilizers should be listed under Section VI.E: presurgical and surgical procedures - and not here.)
    • In answer to "Expected Experimental Effect on Animal": Answer what effect is intended with relation to the experiment. "Expected Detrimental Effect on Animal" refers to any adverse side-effect the substance may cause in the animal.
    • Reproduce this section for each substance/device to be used.

Back to Application

  1. Experimental Procedures Not Involving Surgery and/or Euthanasia

    1. Self-explanatory
    2. Give a brief chronological description of all non-surgical experimental procedures planned. Examples: restraint techniques (manual, restraint device, chemical), anesthesia, body fluid collection (blood, urine), gavage, oral administration of liquids or solids (special diets, pharmaceuticals), non-standard housing (metabolic caging), etc.
      • If medications, chemicals, special diets, devices, anesthetics, sedatives, or tranquilizers are used in the non-surgical procedures, list them under Section VII.C.
    3. In answer to "Expected Experimental Effect on Animal": Answer what effect is intended with relation to the experiment. "Expected Detrimental Effect on Animal" refers to any adverse side-effect the substance may cause in the animal.
      • Reproduce this section for each substance/device to be used.

Back to Application

  1. Biohazardous/Radioactive Materials

    1. If you plan to use radioactive materials in your project, you must contact the Radiation Safety Office at x55623.
    2. Self-explanatory.
    3. If "Yes" was indicated for VIII. A., B., and/or C., identify the biohazard, carcinogen, radioisotope, or radiation dose.
    4. Indicate how the biohazard, carcinogen, radioisotope, or radiation dose is administered to live animals and what precautions are to be taken to ensure the safety of the Vivarium personnel and other animals.
    5. Indicate by name the individual(s) responsible for ensuring the required measures noted in VIII.F. will be taken.

Back to Application

  1. Special Considerations

    1. Pain studies: If yes is checked for IX.A, include a justification based on the scientific merit and potential benefits that would outweigh the induced discomfort and animal stress.
    2. - E. Self-explanatory.
    1. Carcasses must be frozen prior to disposal. Contact the Animal Resources Office at x55483 for proper disposal procedures.
    1. 1. Self-explanatory.
    1. 2. The IACUC can grant approval for non-AVMA (American Veterinary Medical Association) recommended euthanasia procedures, if they are clearly and scientifically justified (supported by literature references), and only after competency in the proposed method is verified by the Attending Veterinarian. Examples of non-AVMA recommended methods: Decapitation or cervical dislocation without prior sedation or anesthesia.
    1. 3. If euthanasia of experimental subjects is not required at the completion of your experiment, contact the Animal Resources Staff. It may be appropriate for other researchers to utilize them for other purposes.
    1. The Animal Resources Staff is always available, upon request, to provide instruction/assistance relating to biomethodology: anesthesia, handling, restraint, injections, body fluid collections, euthanasia, surgery, post-operative care, physical examination, etc.

Back to Application

  1. Justification of Animal Numbers

    • If multiple studies are included in this application, complete a separate Section X. for each one.
    1. 1. Will this be an instructional or demonstration exercise?
    1. 2. Is this study a research project?
    1. 3. A teaching or training protocol is one in which all of the following conditions are met:
      • The procedure being taught is recognizable as an established technique by one of the following criteria: it (i) is established as a standard technique by appearing in the peer review scientific literature, or (ii) is established by data collected from previous research and available for review by the Institutional Animal Care and Use Committee.
      • The procedure is being taught to individuals for use in further research.
      • The faculty responsible for the teaching or training must be qualified experts in the procedure being taught.
      • The procedure being taught is intended to train individuals and may not be used to perform research on an existing technique or device or develop a new technique or device.
    • If the above criteria are met, the protocol will be evaluated as a training protocol. Item X.E. must be completed.

      For your information, the following will be required in the annual report for training protocols:
    1. Names of people who were trained.
    2. What were they trained to do?
    3. Dates of training.
    4. Names of faculty conducting training.
    5. How many animals per trainee/procedure were used?
    • Therefore, keep documentation of each training as it occurs.
    1. Differentiate among all experimental and control groups. A group refers to a set of animals with the identical protocol (i.e., drug dosage, time point, age/strain/sex of animals, etc.), applied to them. Provide sufficient detail to enable the IACUC to determine how the groups relate to the justification in part X.D.
    2. Self-explanatory.
    3. 1. A Pilot Study involves relatively few animals. A pilot is done if there are no results available from similar studies, and data is needed to plan or determine the feasibility of a larger study. Sample size represents the best estimate for results.
    1. 2. Self-explanatory.
    1. 3. If your data will be used for statistical tests, your sample size should be justified on the basis of statistical power. If you need statistical assistance, please call the IACUC Chair or the Office of University Research x55314. Please allow sufficient time (3 weeks) prior to submission deadlines for meetings and analyses.

      Attach the supporting sample size report or materials used in power or precision calculations.
    1. 4. If statistical power analysis is not applicable (i.e., tissue collection, antibody preparation, etc.), provide a clear description -- including calculations -- of how the number of animals was determined. Sufficient information must be provided for the IACUC to fully understand your reasoning and verify the numbers.
    1. Complete this section if X.A.3. (Training) was checked.

Back to Application

Assurance

An Investigator Assurance of Compliance with CSU LONG BEACH Guiding Principles and Policies Governing the Care and Use of Animals must be signed by the Principal Investigator and submitted to the Office of University Research.

Request for Modification

During the conduct of an approved project it may become necessary to modify or deviate from the approved protocol. Such changes must be communicated to the IACUC for approval prior to the implementation of the change by use of the Request for Modification of an Approved Project form. The Request for Modification must be typed and submitted to the Attending Veterinarian by e-mail and the Office of University Research. The Attending Veterinarian will either forward the Request for Modification to the IACUC Chair with recommendation for approval and comments or return it to the applicant for change. If approved, the Chair will send the approved Modification to the Office of University Research indicating approval. The IACUC Chair can approve minor modifications to an approved protocol. If approved, the modified activity may begin. The Modification will then be placed on the next IACUC agenda for notice to the full Committee.  Requests for a major modification requires review and approval at a convened IACUC meeting.

Request for Modification

Notes

  • Increase in animal numbers over 10% requires full IACUC review at a convened meeting.
  • Significant modifications require full IACUC review and approval prior to implementation.
  • A change in species requires submission of a new Animal Use Protocol Application.
  • Modification to procedures of radiation exposure, radioactive materials, carcinogens, or biohazards (including Recombinant DNA) requires full IACUC review at a convened meeting.

Annual Report

Annually, the IACUC must review all animal use protocols. This is accomplished through the completion of an Annual Report form that will be sent to the Principal Investigator by the Research Office prior to the expiration of the current approval period.

Annual Report

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