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I%B"I%%nD G /dީ#vE II0I :  Application to Use Vertebrate Animals in Research, Testing, or Instruction IACUC NUMBER Submission Instructions Save this document as follows: last name_new_date.doc Example: smith_new_10_12_2015.doc  HYPERLINK "http://www.csusm.edu/gsr/iacuc/forms.html" Application Instructions Email completed report to  HYPERLINK "mailto:iacuc@csusm.edu" iacuc@csusm.edu at least one week before the meeting NOTE: All spaces expand to accommodate any length of text Date:Principal Investigator/Course Director: (must be a Faculty Member)Project (Course) Title: (If you will be using external funds, please use the same title as the grant application)  Department:Email:Phone Number:Campus Location:Grant or Course No.: Anticipated Funding Sources/Agency:Is funding currently approved?___ Yes ___NoApplication Period (Start & end dates): (Three Years Maximum) Approval Requested by (Date): Is this application: ___New ___Renewal* ___ Modification* of a previously approved application Previous approval date by this Committee: *If renewal or modification, briefly describe below any differences from the previously approved application. For renewals, a complete new application is required. For modifications, answer any items that have changed because of this modification. For items that have not changed, type "NC" (no change) as a response. The principal Investigator's (Course Director's) signature is required in question #9 of the application. Please use an alternate color or highlight all changes to expedite the review process. List and attach copies of any permits required to carry out the proposed protocol. Does this research involve USDA regulated animals? ___Yes ___No COMMENTS \* MERGEFORMAT  1.HUMANE USE CATEGORY* Estimate the number of animals per year of each species in each HUMANE USE CATEGORY. (For examples of each category, see instructions page.) SPECIES ATotalBCDESpecies to be used (common name) include stock/strainEstimate the total number of animals to be used. Se COMMENTS \* MERGEFORMAT e HYPERLINK "http://www.csusm.edu/gsr/iacuc/forms.html"instructions for category descriptions(To add additional lines, continue tabbing at end of line/section) 2. Summary and Justification of the Proposed Research or Project:Provide an abstract or summarize the aims and objectives of this animal research, testing or instructional project. For instructional projects, include any potential benefit to students. (Please use nontechnical language that a layperson can understand.) Does the proposed research duplicate previous experiments? If so, why is it necessary to repeat such studies? 3.Judicious Use of Animals (explain in language that a layperson can understand).a) What are the probable benefits of this work to human or animal health, the advancement of knowledge, or the good of society? b) Can the level of pain or discomfort be further reduced? EXPLAIN. If animals are included under category D or E, you must provide a list of databases searched, date(s) the search was performed, the period covered by the search, and the key words and/or search strategy used to search for possible alternatives to painful/distressful procedures as defined by USDA policies 11 and 12. If some other strategy was used to assure compliance with the requirement that alternatives were considered, please describe below. c) Have you considered using non-animal models (e.g., mathematical models, computer simulation, or in vitro biological systems) as alternatives to the use of animals in this project? EXPLAIN d) Justify the animal species to be used. Describe the biological characteristics of the animal that are essential to the proposed study. Include evidence of experience with the proposed animal model and manipulation. Are other animals suitable for this work? e) Define the animals (stock/strain, sex, weight/age, etc.) and explain how the relative numbers were determined, justifying the number of animals to be used. Describe the size and number of experimental groups; number of animals needed for procedure development; link animal use to scientific goals. Indicate steps taken to reduce the number of animals needed. Specifically, address why fewer animals cannot be used.4.Sources and Location of Animals a) Identify source(s) for acquiring animals.b) Will any animals from this protocol be transferred to other investigators at a later date? ___Yes ___ No If yes, explain.c) Location of Animal Housing:  1) Building Name 2) Room No.(s)  3) Off Campus Sites a) Does this site have an IACUC? ___Yes ___Nob) If the animals are regulated by USDA, does this site have a USDA research certification? ___Yes ___Nod) Location of laboratory in which the experimental procedures will occur  1) Building Name 2) Room No.(s)  3) Off Campus Sites a) Does this site have an IACUC? ___Yes ___Nob) If the animals are regulated by USDA, does this site have a USDA research certification? ___Yes ___Noe) If any animals are to be housed off-site, what procedures will you use to ensure humane treatment? 5.For each species used:  a) Describe procedures to be performed (include surgery) in the order in which they will be performed. Include time frames and intervals for the sequences of procedures (attach additional sheets as needed). If the procedures are to be performed after the animals are killed, so state. b) Indicate any anticipated adverse effects on the animals well being. What criteria will determine the degree of pain/discomfort for these animals? How will you minimize or ameliorate pain, distress, and/or adverse effects?c) Will this project involve recovery from anesthesia? ___Yes ___ NoIf "No" proceed to question 5d. If "Yes" explain your post surgical monitoring and care plan.d) Will this project involve controlled substances? ___Yes ___ NoIf "No" proceed to question 5e. If "Yes, please list the applicable materials: (Chemicals, Controlled Substances, and anything that is not water or buffer).e) Specify test substance(s), agent(s), dose(s), volumes, and route(s) of administration to be used. Pharmaceutical grade chemicals and other substances should be used when available, unless otherwise approved by IACUC. If you plan to use non-pharmaceutical grade chemicals or substances, please justify.f) Specify anesthetic, analgesic or tranquilizer agent(s) to be used, or other measures to alleviate pain or discomfort. Include dose(s), volumes and route(s) of administration. g) Specify method(s) of euthanasia to be used. If drugs are to be used, include dose and route of administration. Specify secondary methods used to confirm euthanasia.h) Will the animals undergo multiple survival surgical procedures (counting surgical procedures from previous protocols)? ___Yes ___ No If "Yes", please provide justification.i) Will blood or other body fluids be collected? If so, indicate the site and method for collection, the quantity and frequency of collection, and the use of any restraining device or anesthetics. j) Describe any sensory or dietary restriction, or experimental stimulation that might adversely affect the health of the animals. k) If the animals are to be restrained for a prolonged period, provide the type of restraint, the duration of restraint, the method of habituation (if any), and the procedures for monitoring the animals while restrained. l) Will any special care be needed? What will it entail and who will provide the care? 6.Does the research, testing, or instruction require the use of any of these hazardous agents? Check all that apply.___ Infectious agents ___ Biologic Toxins ___ Recombinant DNA ___ Carcinogens ___ Radioactive substances ___ Chemical Hazards___ Other (Describe): ___ Check here if hazardous materials are commonly used disinfectants, cleaning agents, or anesthetics where normal containment protocols will be followed. For all other hazardous materials checked above, attach a copy of or describe the containment protocol to be followed in protecting other animals and personnel from the hazardous agents:Will special handling of animal or bedding be required to protect personnel?7.Personnel. Identify the names, qualifications, experience, and training of the individual(s):a) Who will be responsible for meeting standards of animal husbandry and housing?  b) Who will provide daily husbandry and care of animals? c) Who will report ill or injured animals? d) Who will perform experimental or test procedures (non surgical)? e) Who will perform surgical procedures (if applicable)? f) Who will monitor the animals during the post operative or anesthetic recovery period? g) Who will perform euthanasia on the animals? h) What training will these personnel receive in the care and use of these animals?What are the risks to personnel involved in the care and use of these animals? ___Allergens ___Toxins ___Infections ___Other Please explain any exposures and describe training that will be provided.8.The scientific merit of this project will be reviewed by (specify): Federal agency (e.g. NIH,NSF,FDA) : Non-governmental agency : University review :Other :  Principal Investigator/Course DirectorI acknowledge responsibility for this project. I have read the Principles for the Care and Use of Laboratory Animals and certify that this project will be conducted in compliance with those principles. I assure that I will obtain IACUC approval prior to significant changes in the protocol. I assure that students, staff, and faculty on the project are qualified or will be trained to conduct the project in a humane and scientific manner.I completed the on-line training course, Working With the IACUC on the following date: Printed Name (Principal Investigator/Course Director):  Date:   Proposals submitted to the IACUC must include sufficient documentation to assess the adequacy of precautions to control exposure of personnel to the hazardous agents involved in animal experiments. A hazardous chemical is defined by OSHA as any chemical, chemical compound, or mixture of compounds that presents a physical or health hazard. These include allergens, embryotoxicants, carcinogens, toxic or highly toxic agents, reproductive toxicants, irritants, corrosives, sensitizers, hepatoxins, nephrotoxins, neurotoxins, hematopoietic systems agents, and any agents that damage the lungs, skin, eyes, or mucous membranes. Approved anesthetic and euthanasia agents are considered hazardous if they meet the criteria for hazardous chemicals.     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