California State Polytechnic University, Pomona Animal Care and Use Committee (acuc)



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1. TEACHING LABORATORY EXERCISE. If this protocol is to be used in a laboratory exercise in a regularly scheduled class, please complete this subsection. In the table below, please note the course(s) in which the proposed animal procedures will be carried out, the academic years during which the course will be taught, and the academic periods in which the course will be taught. Please also indicate the number of students who take the course and the number of animals that will be used per academic year.

Course prefix,

number and title

Academic years in which the course will be taught

(maximum of 3)

Quarters/semesters taught

(Fall, Winter, Spring, Summer)

Number of animals per year

Number of students per year

















































  1. Describe the rationale for the number of animals to be used. Include the number of students per animal or per animal encounter. [For example, a team of two or three students will practice blood withdrawal from one cow up to ten times, for a maximum total of 30 needle pricks per animal.]


  1. Is a copy of the laboratory exercise attached for the ACUC to review? Yes or No: . What course objectives are satisfied by the use of animals? Provide the full citation of the source from which the exercise was taken.


  1. Non-animal alternatives: If any laboratory exercise(s) in this course utilizes non-animal alternatives (e.g., videos, computer lessons, veterinary mannequins, mechanical teaching devices, or other simulations) or live tissue alternatives, briefly describe the exercise(s). If no laboratory exercises in this course utilize non-animal alternatives, please justify.


  1. Occupational health and safety: All class participants must review the CPP “Risk Assessment Screening Questionnaire” to allow them to self-assess their risk to exposure with animals. It may be completed electronically at https://academic.cpp.edu/acuc_ehs/ or obtained as a paper copy at the following site: http://www.cpp.edu/~research/acuc/safety-related-documents.shtml. Faculty are obligated to ensure that students have been made aware of it. Please indicate your understanding of this requirement by entering your initials here: .




  1. Privately-owned animals: For situations where privately-owned animals will be used in the above named courses, there are two applicable policies as follows. 1) Memorandum of Understanding - Permission to Have an Animal in a University Activity at http://www.cpp.edu/~research/acuc/documents-and-links.shtml and 2) the ACUC policy on “Privately-owned animals on campus, including use in classroom studies” available at the ACUC website page. Please indicate your understanding of these policies by entering your initials here: .




  1. How will the animals, both campus- and privately–owned, be identified and tracked for usage in teaching protocols? Who will be responsible for maintaining the records?

2. RESEARCH PROJECT (FACULTY OR STUDENT). Complete the relevant parts of this subsection if this protocol is for a faculty, graduate student, or undergraduate student research project (including term projects in regularly scheduled courses) which take place either on campus or off campus.


  1. If this is a student project, please report the following information for all students involved.

Name

Bronco ID

Major

Status

(Undergraduate/Graduate)

Phone number
































































  1. If this is a student research project which is associated with a course, please indicate the course information (i.e., catalog number, McNair Scholar, Honors College, etc.). If this is a master's thesis research, simply indicate "thesis".


  1. Project period (provide month and year): from through .




  1. If this proposal has been submitted for funding, provide the title of the submitted proposal (if different from title given above). Provide relevant sections of the grant proposal (e.g., for PHS grants, section 12 on Vertebrate Animals, 1. Proposed use of animals and the section “other project information”) as uploaded .docs or PDFs:

Source(s) of requested funding and date(s) submitted:




  1. Occupational health and safety: All participants involved in research projects must review the CPP “Risk Assessment Screening Questionnaire” for self-assessment of one’s risk from exposure to animals and then possibly complete the "Confidential Health History Questionnaire for Students, Faculty, Staff and All Others Exposed to Laboratory Animals" as administered by CPP’s Environmental Health and Safety Office (links below). Faculty are obligated to ensure the submission of these documents. Please indicate your understanding of these requirements by entering your initials here: .

These documents may be obtained via the following links:



http://www.cpp.edu/~research/acuc/safety-related-documents.shtml

e-version at https://academic.cpp.edu/acuc_ehs/



3. PAIN CLASSIFICATION "C". Please answer the following questions for any section of the proposed animal study where there will be significant unavoidable pain or distress which cannot be relieved by the use of drugs:

  1. What is the scientific justification for the procedure(s)? Explain why pain cannot be alleviated, document consideration of alternatives, and, if there are procedures involving less pain, explain why these procedures are not being used.


  1. Has the ACUC Veterinarian been consulted in planning these procedures? Yes or No: .

If not, please explain:

4. ALTERNATIVES TO DEATH AS AN END POINT. The ACUC is concerned about humane endpoints as in LD50 or tumor studies. If the proposed use of animals is one in which painful or stressful outcomes are anticipated (pain class “C”), then it is necessary to include criteria to be used in identifying animals that are about to die (are moribund). Include your process for timely intervention to remove them from the study for treatment, or to euthanize them. You may attach recordkeeping forms to the ePS – please note that here.

  1. If it is necessary to continue this experiment until any of the animals die as a result of the experiment, then fully justify the requirement.


  1. Criteria – provide a list of observable criteria (e.g., weight loss, tumor size, physiological responses) to assess morbidity to use in identifying animals to be removed from the study.


  1. Frequency of observation – what is the period of time during each experiment when morbidity is most likely to occur and, during this time, what will be the frequency of observation and assessment of the animals? Importantly, who will make these observations?


  1. Process – what procedures are to be followed when it has been determined that an animal is to be removed from the study? Be sure to specify what individuals have the authority to make this determination and what other individuals, if any, must be contacted before animals are removed. What is to be done with animals removed from the study?

5. PROLONGED RESTRAINT. If animals will be subjected to prolonged (more than momentary) restraint, please describe the following. Examples include having pigs in a sling and rodents in a tube for multiple blood samples for hours-long periods.

  1. Type/Method of restraint (e.g., rabbit plastic restrainer, tethering, chairs, stanchion).


  1. Time duration of restraint (e.g., 1 to 2 hours, overnight) and frequency.


  1. Scientific justification for the restraint.

6. PROCEDURES INVOLVING SURGERY, GENERAL ANESTHESIA, SEDATION, TRANQUILIZATION. (also complete subsection 5 of Section IX):

  1. Number of animals to be operated on and/or anesthetized/sedated/tranquilized.


  1. Describe the anesthetic, sedative, and tranquilizing agent(s) to be employed (state name, dosages/weight and route of administration).


  1. Describe monitoring and supportive care (EKG, IV solutions, etc.) to be provided during surgery.


  1. Provide a description of the surgical procedure. An SOP may also be attached to the ePS.


  1. What are the training and experiences of individual(s) who will perform the surgery and/or anesthesia, sedation, and tranquilization? Be detailed in the response.


  1. Are paralytic drugs (e.g., curare or pancuronium) to be used? If so, name the drug including dosage and route of administration and describe how the absence of pain will be assessed (use of paralytics without anesthesia is prohibited).

7. SURGERY FOLLOWED BY RECOVERY. If the animals are expected to regain consciousness following the surgical procedure, please answer the following (also complete subsections 5 and 6 of Section IX):

  1. How will asepsis be maintained during the surgical procedure?


  1. Describe the supportive care (fluids, warm environment, etc.) to be provided during recovery.


  1. Describe analgesics and/or anti-inflammatory agents to be administered after surgery (state dosages, frequency, duration of medication administration, and route of administration).


  1. Describe antibiotics to be administered after surgery (state dosages, frequency, duration of medication administration, and route of administration).


  1. Who will provide postoperative care (including management of postoperative complications) which may be necessary during normal working hours as well as weekend and holiday care?

F. Describe the potential complications that could occur as a result of the procedure/surgery.



8. REPEATED SURGERY ON THE SAME ANIMAL. (also complete subsections 5, 6, and 7 of Section IX) If more than one major surgical procedure is to be performed on a single animal, please describe and justify. Know that the ACUC will especially review this subsection.

9. COLLECTION OF ANIMAL TISSUES OR FLUIDS, WHETHER OR NOT INVASIVE. This subsection is intended for live animals. If the procedures include harvesting during necropsy, please note that.

  1. Describe what tissue(s), body fluid(s), or other samples are to be collected:


  1. Amount to be collected and at what frequency:


  1. Describe the method(s) of collection:


  1. Will an anesthetic, sedative, or tranquilizer be administered prior to collection? Yes or No: .

(If yes, complete subsections 5 and 6 of Section IX).

10. MAINTENANCE OUTSIDE OF DESIGNATED ANIMAL HOUSING FACILITIES. If animals will be maintained in a laboratory or other area not designated for housing of laboratory animals at California State Polytechnic University, Pomona, for more than twelve consecutive hours, then answer the following:

  1. Location and describe the facilities that will be used to house the animals:


  1. Justification:


  1. Who will provide the husbandry and veterinary care in this area? What is the experience and training of the individual(s)?

11. AQUATIC SPECIES (fish, amphibia, and aquatic reptiles). When aquatic species are to be used, there are specific animal care and use requirements to address. Some responses may overlap with field studies involving aquatics.

  1. Provide details of tank(s) or enclosures and the cleaning schedule.


  1. Describe maintenance of water quality (e.g., filtered, frequency of change, temperature, pH, nitrates, chlorine, etc.).


  1. Describe routine animal care procedures (e.g., feeding schedule, checking for health of animals).


  1. Describe any hazards (biological, chemical, or physical) associated with the maintenance and care of aquatic species and emergency procedures pertinent to the safety of aquatic species and personnel who care for them.

12. USE OF HAZARDOUS MATERIALS. If hazardous materials including radioisotopes and toxic substances are to be used, answer the following. Attach approval from the CPP Radiation Safety Committee and/or the Office of Environmental Health and Safety, as appropriate.

  1. Radioisotope(s):


  1. Other hazardous material(s) or toxin(s):


  1. Amount to be used:


  1. Role of material in study:


  1. Degree and nature of risk to personnel:


  1. Safety precautions for personnel directly and indirectly involved:


  1. Means of storage of hazardous material:


  1. Means of disposal of hazardous material including contaminated animal carcasses, bedding, and wastes:

13. USE OF BIOHAZARDS. If infectious agents, tumor cells, recombinant DNA, mammalian tissues, transgenic animals, genetically modified whole plants or other hazardous biological materials (see info at link to list at EH&S) are to be used in the proposed study, it may be necessary to complete paperwork and obtain approval with the Institutional Biosafety Committee (IBC, http://www.cpp.edu/~ehs/portals/biosafety/ibc.shtml) in the Office of Environmental Health and Safety (EH&S). The IBC has a biosafety survey, instructions, and submission forms to help guide the process. Approvals from the ACUC and IBC can be done in parallel.

  1. Has the proposed use been reviewed and approved by the IBC? Enter, as appropriate: yes, no, unsure, in process.



  1. Please explain the current status of the IBC application and provide appropriate documentation, e.g. biosafety survey submission ID number and approval memo.


  1. What animal Bio-Safety Level (ABSL) is recommended for these biohazards by the appropriate regulatory agencies? Please consult the current edition of “Biosafety in Microbiological and Biomedical Laboratories” (CDC/NIH) for guidance and the documentation of procedures. Additionally, per the NIH Office of Biotechnology Activities, “The maintenance of a transgenic rodent colony (i.e., breeding within a particular transgenic strain) at BL1 is an activity that is exempt from the NIH Guidelines and, as such, does not require IBC registration and approval. The maintenance of a transgenic rodent colony at BL2 or higher falls under Section III-D-4-b and requires IBC approval”. (http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html)


  1. What are the genus, species, and serotype of pathogenic organisms included in this study?


  1. Describe the pathogenicity of the organism(s) or agent(s) being used. What PPE (personal protective equipment) is needed for personnel?

14. USE OF TEST SUBSTANCES. If a test substance (e.g., a dietary additive) other than the hazardous materials described above is to be administered, answer the following:

  1. Test substance(s), dosages, and route(s) of administration:


  1. Number of animals to receive the test substances:


  1. What are the expected outcomes of administration? How will the animal(s) react? Will there be any toxic metabolites in blood, urine, feces, bedding, etc., as personnel safety concerns?

15. USE OF CONTROLLED SUBSTANCES. If controlled substances (e.g., narcotics or barbiturates) are to be used, describe security arrangements and who (name(s) and DEA license number) will be responsible for the record keeping (details at http://www.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_04.htm) and use of these drugs. To determine whether a substance used in your proposed experiments is a controlled substance, review the information provided by the U.S. Department of Justice Drug Enforcement Administration. Controlled substance records are subject to inspection by the ACUC at any time while this protocol is in effect.

16. MEANS OF DISPOSAL OR FURTHER USE OF ANIMALS NOT EUTHANIZED. Please describe as applicable. Per federal guidelines (Appendix Q-I-B-1, http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html) on recombinant or synthetic nucleic acid molecules, genetically-modified organisms are not permitted to be used as food for other animals. For example, transgenic mice cannot be fed to the reptiles, but wild types can be.

17. RESEARCH OR TEACHING UTILIZING WILD ANIMALS

  1. If animals will be obtained from a commercial supplier, give the supplier's name:


  1. If you will be responsible for capturing animals from wild populations, attach a copy of the appropriate wildlife agency approval(s), and answer the following questions:

    1. Describe the method of capture. Describe safety and protective measures for personnel involved.


    1. Describe procedures to ensure the well-being of the animals after capture and during transportation to and from the research site. See the ACUC policy on transport of animals while conducting studies in the field.


  1. Do you have written and available SOPs (standard operating procedures)? Yes or No: . Please attach and describe:

D. Are any of the animals being used classified as endangered species or at risk of endangerment? Are special permits required (CITES – the Convention on International Trade in Endangered Species of Wild Fauna and Flora, California Department of Fish and Wildlife, etc.)?



18. WORK TO BE CONDUCTED OFF-CAMPUS (INCLUDING FIELD RESEARCH AND TEACHING)

    1. If the research or teaching involves the use of some Cal Poly Pomona facilities (e.g., the housing of animals) but will occur primarily at another institution which is taking responsibility for approval of the protocol, provide a copy of the IACUC approval from that host institution. If this is the case, you need only complete the sections of this protocol form which relate to the use of Cal Poly Pomona facilities. Please provide a clear explanation of how the Cal Poly Pomona facilities will be involved under Section III "Description of the proposed use of animals."


    1. Field research or teaching: Complete all relevant sections of this protocol application. Explain the location of the study site and, where appropriate, provide evidence of permission (permit, license; see 17.D.) to use the site. See also the ACUC policy on transport of animals while conducting studies in the field regarding animal care and personnel safety.

19. COLLABORATORS OR EXPERTS CONTRIBUTING TO THE PROJECT. List all collaborators or other experts who will contribute substantially to this project, and explain their participation and qualifications for the intended contributions.

20. LITERATURE CITED FOR THE RESEARCH PROJECT (FACULTY OR STUDENT). Provide a complete list of the literature cited. This could be relevant to the animal model, housing, methods, or other.

21. PRINCIPAL INVESTIGATOR (PI) PUBLICATIONS RESULTING FROM PREVIOUS USE OF ANIMALS IN RESEARCH. Provide a complete list of PI publications that have resulted from the use of animals in research.

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