Eastern Kentucky University Animal Care and Use Application IACUC Protocol Number: _______________ I. ADMINISTRATIVE DATA Type of Application: Purpose: New Research Renewal of previously approved protocol number: Other: Project Title: Duration of Project: through Principal Investigator: Name: Department: Mailing Address: Telephone Number: Email Address: Faculty Advisor: (required if PI is a student) Name: Department: Mailing Address: Telephone Number: Email Address: Other Investigators/Personnel Identify all individuals who will be involved in this project (i.e., co-investigators, student research assistants). Attach additional pages if needed. Name: Rank/Title: Responsibility in Project: Name: Rank/Title: Responsibility in Project: Funding Source (attach copy of grant proposal narrative): As principal investigator/faculty advisor, I hereby assure that: Regulations: I am familiar with The Guide for the Care and Use Laboratory Animals and agree to abide by the guidelines established therein in the conduct of this project. (As appropriate and approved by the IACUC, the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, or appropriate guides for amphibians, reptiles and avians, may be used.) Animal Use: The animals authorized for use in this protocol will be used only in the activities and in the manner described herein, unless a deviation is specifically approved in advance by the IACUC. I understand that I am responsible for ensuring that the animals’ living conditions are appropriate. Alternatives/Duplication: I have made a reasonable, good faith effort to find and utilize alternatives and refinements to these procedures and to avoid unnecessary duplication of previous experiments, unwarranted animal use, and unnecessary painful procedures. Statistical Assurance: I assure that there has been adequate evaluation of the statistical design or strategy of this protocol, and that the minimum number of animals needed for scientific validity are used. Training: I verify that all personnel, including students, who will be involved in the performance of this project have completed an educational program on the proper care and use of animals (i.e., the CITI Lab Animal Welfare Course). A copy of each individual’s certificate is attached. I further certify that I have an appropriate background in the biology, handling, and care of the species used in this project and will provide all personnel with training and supervision as appropriate for this protocol. I agree to maintain, and ensure the project personnel maintain, current training and furnish documentation to the IACUC in a timely manner. Permits/Licenses: I verify that I have obtained all appropriate permits and licenses to conduct the activities described in this protocol. A copy of relevant documents are attached. I agree to maintain current permits and licenses as applicable throughout the approval period of this protocol and furnish up-to-date documentation to the IACUC in a timely manner. Records: I understand that all records relating to this project must be maintained for a period of at least three years following the project’s completion. I agree to make these records available for inspection at the request of the IACUC. Access to Animals: I understand that any member of the IACUC, including the attending veterinarian, may enter the premises where these animals will be used or housed at any time for the performance of official duties. Principal Investigator Date Faculty Advisor, if applicable Date As Department Chair, I hereby acknowledge receipt and review of this protocol and approve its submission to the IACUC Department Chair Date ____________________________________________________________________________________________________ Please submit one original of all application materials to Sponsored Programs, Jones 414, Coates CPO 20 II. ANIMAL USE SUMMARY In language understandable to a layperson, briefly describe the proposed project or course, its primary aims, the major reasons for using live animals, and the procedures to which the animals will be subjected. Please limit the summary to the space provided on this page. Page 2 of 4 III. ANIMAL REQUIREMENTS Animal Common Name Source (i.e., vendor) Total # Animals to be Used Pain Level* Pain Drugs Used What is the approximate % of animals that will survive? ** *Use appropriate letter to indicate maximum pain level/discomfort/distress to be experienced by animals: USDA Category B USDA Category C USDA Category D USDA Category E Breeding or Holding Colony No more than momentary or Pain or distress appropriately Pain or distress or potential pain Protocols slight pain or distress and no use relieved with anesthetics, or distress that is not relieved of pain-relieving drugs, or no analgesics and/or tranquilizer with anesthetics, analgesics pain or distress. drugs or other methods for and/or tranquilizer drugs or relieving pain or distress. other methods for relieving pain or distress. **Be sure to fill out euthanasia portion of Form E, or non-survival surgery portions of Form S if some percent of animals will not survive For pain level E: As evidence of your assurance that you have considered alternatives for procedures that may cause more than momentary or slight pain or distress, please provide a narrative description of the methods and sources (i.e., Animal Welfare Information Center) used in making this determination. Avoidance of Unnecessary Duplication: As evidence of your assurance that activities in this protocol do not unnecessarily duplicate previous experiments, please provide a list of literature sources reviewed in making this determination. Please note that this section is not required if the protocol is for teaching activities. Teaching experiments are not considered duplicative because each time a procedure is performed for a new group of students or audience, new knowledge is gained. IV. RATIONALE FOR ANIMAL USE Narrative attached 1. Explain your rationale for animal use. The rationale should indicate reasons why non-animal models cannot be used (i.e., computer modeling, etc.). Cite evidence from a literature review as part of your rationale. 2. Justify the appropriateness of the species selected. Explain why the species is appropriate for the proposed activity. 3. Justify the number of animals to be used, including an explanation of how this number was determined. The number of animals should be the minimum number required to obtain statistically valid results. V. PROCEDURES 1. Procedures/Methods: Describe in detail the procedures and methods to be carried out in this project. A copy of a research proposal narrative may be attached in lieu of presenting the information below. Narrative attached 2. Pain: If pain is involved, what criteria will be used to assess pain/discomfort? Loss of appetite Guarding (protecting the painful area) Loss of weight Licking, biting, scratching, or shaking a particular area Loss of mobility Failure to groom, causing an unkempt appearance Vocalizing Failure to show normal patterns of inquisitiveness Restlessness Abnormal resting postures in which the animal appears to be sleeping or is hunched up Other: 3. Drug Use: If drugs are used to minimize pain/discomfort, please list below. Species Drug Dose Page 3 of 4 Route Frequency Will Drug Enforcement Agency (DEA) controlled substances be used? Yes No If yes, list substances below and attach copies of DEA permit(s) for substance(s). 4. Animal Housing: List the specific location (building and room number) where animals will be housed. If animal quarters are requested in the Department of Biological Sciences’ animal facilities, a letter from the department chair granting approval must be attached. Will animals be held in a study area outside the animal facility for more than 12 hours? Yes No If yes, identify where and describe under what conditions the animal(s) will be held. Be specific and describe care that will be provided to the animals. 5. Human Medical Risks and Precautions: Provide a description of the medical risks that may be present for individuals involved in this project (i.e., rabies, allergies, etc.) Describe medical precautions that have been taken to protect personnel involved in the project (i.e., pre-rabies exposure immunization, tetanus immunization, etc.). 6. Special Concerns: Please indicate whether your project includes any of the following. Blood and/or tissue collection Nutritional studies Behavioral studies Sedatives Use of immobilizing agents or muscle relaxants without anesthesia Antibody production and collection Surgery (Attach Form S) Euthanasia (Attach Form E) Physical Restraint or Induction of Stress (Attach Form P) Potentially Hazardous Materials (Attach Form H) VI. APPLICATION CHECKLIST *Animal Care and Use Application Form with original signatures *Verification of Training for all Personnel *Form W: Animal Worker Questionnaire for all Personnel *Form E: Fate of Animals at End of Course or Study Form H if project involves potentially hazardous materials Form P if project involves physical restraint or induction of stress Form S if project involves surgical procedures Letter of approval if animals are to be housed in the Biological Sciences animal facility Collecting permit(s) if applicable DEA permit(s) if applicable *Required for all applications Page 4 of 4