Lake Superior State University Institutional Animal Care and Use Committee APPLICATION TO USE VERTEBRATE ANIMALS (Invasive Procedures) University policy and federal law require a review of projects for humane treatment and judicious use of vertebrate animals. At Lake Superior State University, adherence to this policy and federal law is assured by the Institutional Animal Care and Use Committee (IACUC) through review of this Application to Use Vertebrate Animals (AUVA) for research, testing, or instruction. While fulfilling its responsibility to ensure the judicious use of animals, the IACUC also reviews applications for scientific or instructional merit. Projects Requiring Review The Principal Investigator (PI) or Course Instructor (CI) must obtain approval from the IACUC before initiating research, testing, or, instructional use of vertebrates. Failure to do so is a violation of federal law. The following types of animal use do not require IACUC review: 1. 2. 3. Invertebrate animals Whole dead animals not regulated by USDA e.g. ectothermic vertebrates, birds, Rattus sp., and Mus sp. Animal tissues, fluids, internal organs, eggs, embryos, fetuses, etc. obtained as a commercial product or as a byproduct of another IACUC-approved research project If you are uncertain whether an IACUC review is required for your project, please contact the IACUC for a determination. The Application Review Process Applications are reviewed each academic semester. Completed applications should be submitted electronically to the IACUC. After an administrative review, applications are forwarded to members of the IACUC for a formal review. Following this review the project will be either: 1) Denied – The IACUC has determined that the project does not meet the standards of humane use, or has serious scientific flaws. No vertebrate use is approved. 2) Conditionally Approved – The IACUC has determined that the project does meet the standards of humane use, but exhibits minor scientific flaws or lacks clarity. The PI/CI must address these issues and re-submit a complete application. No vertebrate use is approved. 3) Approved – The IACUC has determined that the project meets the standards of humane use and is free of scientific flaws. Vertebrate use is approved. The PI/CI will be contacted by the IACUC to resolve any issues of concern to the IACUC members. Following approval, an Approval Number will be assigned. This Approval Number must be referenced on animal care and use documents and may be requested by outside inspectors. Page 1 of 9 Application for the Use of Vertebrate Animals Approval Period and Annual Review IACUC approval is valid for a maximum of three years for faculty research projects or instructional activities. For multi-year projects, the PI/CI will be sent a brief Annual Review Form. Completion of this form is required for compliance with the regulations of the Federal Animal Welfare Act. Failure to return the Annual Review Form is a violation of federal law and will lead to inactivation of IACUC approval to use animals. The approval period for undergraduate research projects is limited to one year (undergraduate projects are eligible for renewal). Modifying Approved Applications Prior to making significant changes in animal research activities, investigators must receive approval of the proposed changes from the IACUC. These changes should be described in a written narrative. The name of the PI/CI, current Approval Number, and title of the project must be referenced in the narrative. The PI/CI should be sure to describe all aspects in which the change may alter their approved protocol. This is best accomplished by reviewing the currently approved application, and addressing each question affected. A modification to an approved application undergoes the same review process as do new or renewal applications. Investigators should allow 2-3 weeks for review of modifications by the IACUC. General Instructions The application should be completed and submitted electronically. Complete the application in its entirety. Abbreviations Invasive Procedures must be clearly spelled out and/or defined upon first use. Applicants may find that they will be asked to provide brief answers regarding issues which they have discussed in detail in another part of the form. Please answer each question as stated and do not simply refer to another answer elsewhere in the application. Michigan Freedom of Information Act Applicants should be aware that approved applications may be obtained through the Michigan FOIA. Applications should be written in a manner which will allow them to sustain public scrutiny. Avoid unnecessary use of inflammatory descriptive language. For example, when discussing euthanasia, use the word "euthanize" and avoid the use of the words "sacrifice" and "kill". Where practical, include sufficient detail and explanations to address anticipated questions and concerns from the general public. Unacceptable Applications Reasons why applications may not be for review include, but are not limited to: Incomplete applications Use of an obsolete form The PI/CI is not affiliated with LSSU Use of technical language that a nonscientist might not understand in Questions 3 and 4 Inadequate description of animal use procedures in Question 11 A single composite answer to questions with multiple subparts Missing signatures Page 2 of 9 Application for the Use of Vertebrate Animals Invasive Procedures For IACUC Use Only Date Received ____________ Approved Approval Date ____________ Approval Period _________ Approval # ________ New Application Revised Application Renewal Application Conditional Denied Conditional Approval Date Click here to enter a date. Approval # Click here to enter #. Save the completed application as a Word file (<name>_AUVA.docx) and email to the IACUC chair. Principal Investigator (PI) or Course Instructor (CI): Click here to enter text. Telephone: Click here to enter #. Faculty Student E-mail: Click here to enter address. Faculty Mentor: Click here to enter name. Project Title/Course: Click here to enter text. List all personnel who will perform procedures involving animals. Name Phone Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Click to enter Duties Page 3 of 9 Application for the Use of Vertebrate Animals 1. Invasive Procedures What species of animal are you requesting to use? (Please provide scientific names) Click here to enter list. 2. What type of animal use is proposed in this application? Basic Research Field Research Testing (e.g. toxicology) 3. Applied Research Instruction or Training Other Specify How would you explain to a non-scientist, the objective(s) of the proposed work? Click here to enter text. 4. How would you explain to a non-scientist, how the proposed animal use will advance our knowledge? Click here to enter text. 5. Check all planned experimental or instructional procedures* that will be performed on the animals requested in this application. All procedures checked below must be explained in Question 11. Addiction or addiction withdrawal Anesthesia Antibody production Behavior modification Blood collection Breeding Catheterization Capture of wildlife Environmental manipulation Euthanasia Food/water manipulation Injection Noxious stimulus Obesity, experimental Restraint Sensory dysfunction Stress Surgical procedure, non-recovery Surgical procedure, recovery Toxicity test Other Specify * If no invasive procedures are planned you should complete the Non-Invasive Procedures Application. 6. Indicate how you have monitored scientific advances that would enable you to use less painful or distressful procedures. Page 4 of 9 Application for the Use of Vertebrate Animals Invasive Procedures Review of scientific journals Attendance at scientific meetings Discussion with colleagues Click here to enter text. 7. What anesthetic agent(s) will be used? ( None. Go to question 8) a. Dosage (mg/kg) Click here to enter text. b. Route of administration Click here to enter text. c. Frequency of administration Click here to enter text. d. What will be the maximum duration of anesthesia? Click here to enter text. e. How will depth of anesthesia be monitored? Click here to enter text. f. What indications will be used to determine that supplemental doses are required? Click here to enter text. g. Are animals expected to recover from anesthesia? h. Describe the post-anesthetic monitoring plan. Yes No (go to 8) Click here to enter text. 8. What analgesic(s) will be used? ( None. Go to question 9) a. Dosage (mg/kg) Click here to enter text. b. Route of administration Click here to enter text. c. Frequency of administration Click here to enter text. d. How will you determine if supplemental doses of analgesics are necessary? Click here to enter text. Page 5 of 9 Application for the Use of Vertebrate Animals 9. Invasive Procedures In the event that it becomes necessary to euthanize animals during or following this project, what method will be used? Click here to enter text. a. AVMA classification of euthanasia methods Acceptable (Go to 9c) Conditional Unacceptable b. Justification for selecting a method of euthanasia classified as conditionally acceptable or unacceptable. Click here to enter text. c. How will you ensure that animals will not revive (e.g. removal of heart, induction of bilateral pneumothorax, observation of rigor mortis)? Click here to enter text. d. What will happen to animals that die or are euthanized during or at the conclusion of the project? Click here to enter text. e. What will happen to the animals that do not die or are not euthanized during this project? Click here to enter text. 10. 11. What drugs will be used for euthanasia? ( None go to 11). a. Drug(s) to be used Click here to enter text. b. Dose (mg/kg) Click here to enter text. c. Route of administration Click here to enter text. Describe all planned procedures to be performed on the animals (e.g., blood collection, surgery, behavioral training, administration of test compounds, breeding, etc.). Include time frames and intervals and describe procedures in the order in which they will be Page 6 of 9 Application for the Use of Vertebrate Animals Invasive Procedures performed. All procedures checked in Question 5 should be described below. Click here to enter text. 12. Describe expected adverse consequences that the animals may experience as a result of the procedures or test compounds described in Question 11. Examples of expected adverse consequences include loss of appetite, post-operative discomfort, pain at an injection site, or loss of animal life including euthanasia. Click here to enter text. 13. Estimate the number of animals of each species that will be used over the duration of the project for each Humane Use Category below. Explain how you calculated the required number of animals. If applicable, indicate the number of animals in experimental and control groups. Humane Use Category Number of Animals 1 Animals will not experience pain, discomfort, or distress for which pain relieving drugs would customarily be given in human medicine or standard veterinary practice. (Examples) Click to enter #. 2 Animals might experience pain, discomfort or distress but appropriate anesthetics, analgesics, or tranquilizers will be used to prevent these effects. (Examples) Click to enter #. 3 Animals might experience pain, discomfort or distress for which anesthetics, analgesics, or tranquilizers would customarily be given but these drugs cannot be used because their use would adversely affect the experimental results or interpretation. (Provide below a description of the procedures producing pain, discomfort or distress in animals and the reasons anesthetics, analgesics or tranquilizers cannot be used). (Examples) Click to enter #. 14. Why must animals be used to accomplish the proposed work? Click here to enter text. 15. Why was the requested species of animals chosen for the proposed work? Describe the biological characteristics of the animal essential to the proposed study. Click here to enter text. Page 7 of 9 Application for the Use of Vertebrate Animals 16. Invasive Procedures Identify the source of the animals to be used in this project. Click here to enter text. 17. Will recovery surgery be performed on the animals? Yes No (Go to 18) a. Who will perform the surgical procedures? Click here to enter name(s). b. Identify and describe the facility where surgery will be performed. Click here to enter text. 18. Will animals be restrained for more than 30 minutes? a. Yes No (Go to 19) Describe the restraint devices to be used. Click here to enter text. b. Specify the maximum duration and frequency of restraint. Click here to enter text. c. Briefly describe the purpose of the physical restraint. Click here to enter text. 19. List any non-target species that are likely to be captured during this project. Click here to enter list. 20. Describe the procedures for handling non-target animals. Click here to enter text. Page 8 of 9 Application for the Use of Vertebrate Animals Invasive Procedures PRINCIPAL INVESTIGATOR'S ASSURANCE I acknowledge responsibility for this project. I am familiar with LSSUs policies for the care and use of laboratory animals and certify that this project will be conducted in compliance with those principles. I have obtained any and all required state or federal permits. (Attach copies of permits) I assure that I will obtain IACUC approval prior to significant changes in the protocol. I assure that all personnel on the project are qualified or will be trained to conduct the project in a humane and scientific manner. _____________________________________________ Signature of Principal Investigator/Course Instructor _________________ Date Page 9 of 9