Three-Year Renewal Application for Animal Use in Research or Teaching General Information First Name * Last Name * Title * Email * Phone * Department * Title of Project * Unit Head (Authorizing Official) Name * Unit Head (Authorizing Official) Department * Other Personnel* (persons who will be working with you on this project such as co-investigators and assistants) First Name Last Name Title Email Phone Department First Name Last Name Title Email Phone Department 1 Three-Year Renewal Application for Animal Use in Research or Teaching Emergency Contact Numbers First Name * Last Name * Email * Primary phone * Secondary phone First Name Last Name Email Primary phone Secondary phone Type of Project * Research Teaching Inclusive Dates of Project Intended Start Date * End Date * Funding Source Date Available Amount 2 Other Three-Year Renewal Application for Animal Use in Research or Teaching Purpose of Project 1. How would you explain to a non-scientist the long-term or overall scientific goals of the proposed research or teaching exercise? (Please define terms and avoid using jargon) 2. How would you explain to a non-scientist the specific objectives of the proposed research or teaching exercise? (Please define terms and avoid using jargon) 3 Three-Year Renewal Application for Animal Use in Research or Teaching 3. How would you explain to a non-scientist the ways this might benefit human or animal health, the advancement of knowledge, or the good of society? 4. Provide a brief summary of your proposed project. 4 Three-Year Renewal Application for Animal Use in Research or Teaching 5. From the list below, check all experimental or instructional procedures that will be performed on the animals requested in this application. Addiction or withdrawal Euthanasia Operant conditioning Amputation Food/water manipulation Anesthesia Gavage Organ/system failure or dysfunction, induced Antibody production Immunization, experimental Ascites production Immunosuppression Biopsy Implant Blood collection Injection Breeding Injury/trauma Burn Inoculation, experimental Cannulation Irradiation Capture of wildlife Irritation, experimental Cardiac puncture Lavage Catheterization Myocardial infarction Collection Noxious stimulus Dental procedure Obesity, experimental Environmental manipulation Observation (no manipulation) Paralysis, experimental Peritoneal lavage Prey, animal Radiography Restraint Sepsis induction Stress Stroke Stun Surgery, non-recovery Surgery, recovery Toxicity test Transplantation Tumor growth, induced Other Animal Subjects Species * Reporting Code * Total Number of Animals for Project * Total Number of Animals for First Year * Maximum Daily Population * 5 Three-Year Renewal Application for Animal Use in Research or Teaching Species * Reporting Code * Total Number of Animals for Project * Total Number of Animals for First Year * Maximum Daily Population * Please describe the procedures producing pain, discomfort or distress in animals and the reasons such drugs cannot be used. Animal Husbandry and Housing Will animal husbandry be a part of this project? Yes No Will GVSU personnel be responsible for all aspects of animal husbandry and housing? Yes No 6 Three-Year Renewal Application for Animal Use in Research or Teaching 1. If the animal housing does not meet or exceed the specifications of the NIH Guide, describe the proposed housing in detail; where housing is located; and justify why nonstandard housing is needed. 2. If the light cycle under which the animals are to be maintained is a controlled cycle, indicate the cycle. Per GVSU protocol Other 3. If the temperature and humidity are to be controlled, indicate the expected temperature and humidity ranges to which the animals will be exposed during the project. Per GVSU protocol Other 7 Three-Year Renewal Application for Animal Use in Research or Teaching 4. If temperature and humidity are not controlled, what is the expected ranges of temperatures and humidity to which the animals will be exposed? 5. If using other than standard commercially available bedding and diet, please provide the rationale for their use. In addition, describe the diet and who will be preparing it (include any additions to a routine diet). 8 Three-Year Renewal Application for Animal Use in Research or Teaching Veterinary Care Will Veterinary care be part of this project? Yes No 1. If someone other than GVSU Veterinary personnel will be responsible for Veterinary care, please complete table below. Name Institution Phone Type of Care: Routine Emergency Animal Use Justification Guidelines issued by the United States Government entitle Principles for the Utilization and care of Vertebrate Animals Used in Testing, Research, and Training () and GVSU policy require that animals selected for procedure should be of an appropriate specs and that the minimum number required to obtain valid results should be used. 1. Why were the requested species of animals chosen for the proposed work? Describe the biological characteristics of the animal that are essential to the proposed project. 9 Three-Year Renewal Application for Animal Use in Research or Teaching 2. Please select how the number of animals needed for the project was determined. (How were the experimental and control group size determined) Statistical Methods Summarize your power analysis: Previous reports with similar procedures Provide a list of 1-3 references: Other Please Explain 10 Three-Year Renewal Application for Animal Use in Research or Teaching 3. Please select why non animal models such as mathematical models, computer simulations, or vitro biological systems, cannot be used as acceptable alternatives to the use of animals in this project. No Alternatives are available (Please provide a justification and evidence to support this statement below) Alternatives are available but are not satisfactory. (Please explain below) Pain and Distress According to the regulations of the Federal Animal Welfare Act [9CFR 2.31 (d)(ii)], the institutional animal care and use committee shall determine that "..The principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources used to determine that alternatives are not available." Alternatives to procedures that may cause more than momentary or slight pain or distress may include: 1. The use of procedures that cause less pain or distress. 2. The use of anesthetics, analgesics or tranquilizers that would reduce pain or distress. 3. The use of methods that do not utilize animals 11 Three-Year Renewal Application for Animal Use in Research or Teaching 1. If you chose B or C in Question 1 of Section III, please describe methods and sources used to determine that suitable alternatives were not available. Use the space below for elaboration. Animal Welfare Information Center Literature Search(specify databases and keywords used below) Review of scientific journals (specify journals below) Attendance at scientific meetings (specify meetings below) Consultation with colleagues(specify colleagues below) Other(please elaborate below) 2. Has a Veterinarian been consulted regarding this project? Yes No Name of Veterinarian Contacted Institute they are affiliated with 3. If your procedures will result in pain and/or distress to the animals which are more than momentary or slight and you experimental plan does not allow for euthanasia of sick or moribund animals please provide scientific justification for withholding these procedures. 12 Three-Year Renewal Application for Animal Use in Research or Teaching Anesthesia Will the animal be anesthetized? Yes (Fill out information below) No 1. Please List those people who will perform the anesthesia Name Title Experience Name Title Experience 2. What will be the maximum duration of anesthesia (minutes) 3. Describe how will depth of anesthesia be monitored? 13 N/A Three-Year Renewal Application for Animal Use in Research or Teaching 4. If paralytic agents will be used, explain how you will assess the degree of analgesia. Controlled Substances Will Controlled Substances be used in this project? Yes (Fill out information below) No 1. List all controlled substances that will be used in this project. 2. Indicate the name of the individual(s) who will be responsible for the use of all controlled substances and all other anesthetics/analgesics used in this project. Only the persons listed below will be permitted to purchase and store these drugs. Name Name 14 Three-Year Renewal Application for Animal Use in Research or Teaching Non-Surgical Procedures Non-surgical procedures include blood sampling, conditions and training procedures, medications, observations, etc. Will non-Surgical procedures be performed? Yes (Fill out information below) No 1. Describe the non-surgical procedures to be performed, including the species and number of animals involved in each procedure. Indicate whether any pain or distress might occur and, if so, state what will be done to minimize or eliminate the pain or distress. Complete the table in (3) below if anesthetics or analgesics are to be used, If these drugs are to be withheld for some reason complete Section III, category C. 2. Indicate all anesthetics, analgesics, or other measures to be used in the alleviation of pain or distress associated with any non-surgical procedure. Species Drug Dosage Frequency of Administration Route of Administration 15 Three-Year Renewal Application for Animal Use in Research or Teaching Species Drug Dosage Frequency of Administration Route of Administration 3. When will the pain/distress alleviation measures be employed? (check all that apply) Before procedure Following procedure At the discretion of the principal investigator During procedure Long Term Other 4. Will un-anesthetized animals undergo physical restraint for more than 5 minutes? Yes No 5. Will procedures involve blood collection? 16 Yes No Three-Year Renewal Application for Animal Use in Research or Teaching 6. Describe in detail any expected clinical conditions or abnormalities that the animals may experience (i.e. weight loss, loss of appetite, pain at injection site, death, etc.) as a result of the non-surgical procedures. Indicate any provisions for the animals' comfort and care should such conditions develop. 7. Where will these procedures be performed? GVSU Other If other, please specify: 8. Please list each personnel who will perform non-surgical experimental procedures, test procedures or teaching demonstrations. Name Department Procedure Name Department Procedure 17 Three-Year Renewal Application for Animal Use in Research or Teaching Please List the experience of each person in the table above in the gives procedure(s) they will perform. Surgical Procedures Will surgical procedures be performed? Yes (Fill out information below) No 1. Describe in detail the surgical procedure(s) to be performed, including the species and number of animals involved in each procedure. 18 Three-Year Renewal Application for Animal Use in Research or Teaching 2. Indicate all anesthetics, analgesics, or other measures to be used in the alleviation of pain or distress associated with any surgical procedure. Species Drug Dosage Frequency of Administration Route of Administration Species Drug Dosage Frequency of Administration Route of Administration 3. List Each person who will perform surgical procedures Name Department Procedure Name Department Procedure 19 Three-Year Renewal Application for Animal Use in Research or Teaching List the experience of each person in the table above in the given procedure(s) they will perform. 4. Will the animals be allowed to recover from surgical procedure? Yes No Post-Anesthetic/Post-Operative Care Will the animal receive post-anesthetic/post-operative care? Yes (Fill out information below) No N/A 1. List all persons who will be responsible for post-anesthetic/post-operative care. (care includes general maintenance, administration of medications, treatments, etc.) Name Department Procedure Name Department Procedure 20 Three-Year Renewal Application for Animal Use in Research or Teaching List the experience of each person for the procedure(s) they will perform. 2. Do you expect animals to experience any pain or distress during the postanesthetic/post-operative period? Yes No Please describe the pain or distress and indicate when the distress might occur (e.g. during restrain or handling, following treatment, etc.) 3. Complete the table below if analgesics/tranquilizing agents will be given to alleviate pain or distress Species Drug Per Protocol Yes 21 No Three-Year Renewal Application for Animal Use in Research or Teaching Species Drug Per Protocol Yes No 4. When will the pain/distress alleviation measures be employed? (check all that apply). Before procedure Following Procedure At the discretion of the Principal investigator (Please explain) During the procedure Long term At the discretion of veterinary personnel Other (please explain) How will you determine whether supplemental doses of post-operative/post-procedural analgesics of tranquilizers are necessary? 5. If any therapeutic drugs/antibiotics will be administered, please list them below. Species Drug Per Protocol Yes No Yes No Species Drug Per Protocol 22 Three-Year Renewal Application for Animal Use in Research or Teaching 6. If you expect animals to develop any clinical conditions or abnormalities (including loss of appetite, weight loss, post-operative infections, wound dehiscence, hemorrhage, paralysis, etc.) during the post-operative period, describe the situation in detail. Indicate any provisions for the animals' comfort and care should such conditions develop. 7. By clicking here you are confirming that you have read and will comply with the provisions of the GVSU Standard Operating Procedure Guidelines for postanesthetic/post-operative care and record keeping for research animals. I agree Euthanasia Is Euthanasia applicable to this project? Yes No 1. Will All animals die or be euthanized during or at the conclusion of this project? Yes No 2. If animals will not be euthanized, state their final disposition. 23 Three-Year Renewal Application for Animal Use in Research or Teaching 3. State the specific criteria for euthanizing abnormal or moribund animals. (Assume someone may have to euthanize animals in your absence.) 4. Add all species that will be euthanized. Species Method of euthanasia Dosage Route of administration AMVA Acceptable Conditionally acceptable Acceptable Conditionally acceptable Species Method of euthanasia Dosage Route of administration AMVA 5. If you have chosen a method of euthanasia that is considered conditionally acceptable, please provide scientific justification. 24 Three-Year Renewal Application for Animal Use in Research or Teaching 6. How will you ensure that the animal will not revive? (the following are suggested: absence of heart sounds, absence of respiratory sounds, dilation of pupils, observation of cyanosis, and/or observation of rigor mortis) Principal Investigator Assurance I acknowledge responsibility for this project. Everyone working under my direction on this project and I will comply with all standards for animal care and investigation established in the Guide for the care and use of Laboratory animals, 8th Ed. (NRC 2011), and the Federal Animal Welfare Act, and will follow all policies established by GVSU to assure that these standards are met. All individuals working with the animals are, or will be qualified by virtue of training or experience to perform proper handling, experimental and errant techniques required for the species to be used I assure that I will obtain GVSU Institutional Animal Care and Use Committee approval prior to any significant changes in the protocol. This research does not represent unnecessary duplication of previous experiments.. I realize that failure to adhere to polices related to animal care and use may result in suspension or revocation of permission to perform animal research in GVSU facilities or to use live vertebrate animals in testing in teaching laboratories and demonstrations. I realize that serious violations of federal regulations must be reported to the Office of Laboratory of Animal Welfare. 25 Three-Year Renewal Application for Animal Use in Research or Teaching Personnel Training/Education 1. Please list those people who will be involved in providing training for the personnel involved in this project. Describe the education, training, or experience that qualifies these individuals to train others in the animal use procedures to be used in this project. Assurance of Scientific or Educational Merit 1. This protocol's scientific or instructional merit has been established by Instructional research Committee Specify Institution Other Please Specify Date Hazardous Agents Are hazardous agents applicable to this project? Yes (Fill out information below) 26 No Three-Year Renewal Application for Animal Use in Research or Teaching Chemical Agent/Chemical Route(s) of Administration Dosage(s) Route(s) of Excretion Known/Suspected carcinogen Yes No Yes No Agent/Chemical Route(s) of Administration Dosage(s) Route(s) of Excretion Known/Suspected carcinogen Radioisotopes Agent/Chemical Route(s) of Administration Dosage(s) Route(s) of Excretion Time period isotope presents hazard Agent/Chemical Route(s) of Administration Dosage(s) Route(s) of Excretion Time period isotope presents hazard 27 Three-Year Renewal Application for Animal Use in Research or Teaching Biological Agent/Chemical Route(s) of Administration Dosage(s) Route(s) of Excretion Indicate species at risk and virulence of agent Agent/Chemical Route(s) of Administration Dosage(s) Route(s) of Excretion Indicate species at risk and virulence of agent Additional Information Describe the measures that will be taken to minimize the risks from all hazards indicated. Specify the procedures that will be used to decontaminate equipment prior to routine washing. Describe the process by which all agents or chemicals listed will be discarded. 28