ࡱ>   bbjbj:: iPP%X44_B_BBBB4CCCCEFC3HrI"IIIUL aN]O;ݵEBOL@QLOO=Q_B_BIIJ[=Q=Q=QO_B8IBI=QO=Q=Q~b8BBʪ.N CPX0q0=Qʪ=QʪJBOOO4 %A:   APPLICATION FOR USE OF VERTEBRATE ANIMALS FOR RESEARCH OR TEACHING RHODE ISLAND COLLEGE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE This form [the Application] and the relevant Appendices provides the Institutional Animal Care and Use Committee (IACUC) with the information it needs to carry out its responsibility to review and approve all vertebrate animal use for teaching and research at ΢Ȧ. Your complete and succinct responses will be appreciated by the reviewers, and will expedite the review process. Please contact the Chair of the IACUC if you have any questions. To be approved the Application must: Explain the scientific or educational motivation for the proposed project. Specify which vertebrate species are to be used and why they are suitable to project goals. Describe what will be done to the animals, why it will be done, and what measures will be taken to minimize pain and suffering. Justify the species and number of animals to be used. Justify why less invasive methods cannot be used for potentially or distressful procedures. Identify who will be involved in the use of animals, what their roles will be, and what experience or training qualifies them to carry out these roles. Include, for projects associated with applications for external funding, a copy of the scientific portion of the funding application. In completing the Application: Include ONLY those Appendices that are relevant to the project being described. Add rows or tables as needed using the tables tool of your word processing software. Add tables as needed by copying and pasting immediately below the original table. Insert N/A (not applicable) where appropriate. You will find grayed rectangle areas when replying to the essay questions. Note that the font is fixed (style, size, blue) and will appear inside the grayed area. This grayed area will not appear when printed. To expedite the review process, it is recommended that you use a colored printer to retain the original font. Your completed form is subject to inspection by the US Department of Agriculture [USDA], and the Public Health Service [PHS]. It is highly advisable that you discuss your research plans with our consulting veterinarian before submission of this Application. Revision of this form is an on-going process. Please send comments and suggestions for improvement to the IACUC Chair). CERTIFICATION PAGE Principal Investigator: Project Title: My signature on the Application constitutes assurance that: the information provided in this Application is complete and accurate due consideration has been given to alternative animal models and procedures that will lesson the possibility of pain and distress in experimental subjects and the proposed experiments do not represent an unnecessary duplication of previous work this project will be conducted in accordance with the Animal Welfare Act, the NIH Guide for the Care and Use of Laboratory Animals, applicable federal and state laws and regulations and the policies of ΢Ȧ regarding the care and use of laboratory animals all personnel who work with animals under this protocol have received appropriate training in procedures and handling methods and new personnel will receive appropriate orientation and training prior to involvement in the proposed studies approval from the Institutional Animal Care and Use Committee will be obtained prior to adding additional animal species to this study, increasing the number of animals used, or increasing the number of procedures performed on individual animals performing procedures not described in this IACUC Application changing approved procedures in any way that might increase the pain/distress category in which the animals are placed, or might otherwise be considered a significant departure from the written protocol allowing other investigators to use these animals on other protocols, or use these animals on another of my IACUC-approved protocols I understand that IACUC approval is valid for one year only, that approval must be renewed annually, that every third year the IACUC must perform a new review of my protocol, and that I might be required to complete a newer version of the IACUC Application and provide additional information at the time of the triennial review. ____________________________________ _______________ SIGNATURE OF PRINCIPAL INVESTIGATOR DATE *** This protocol has been reviewed and approved by the ΢Ȧ Institutional Animal Care and Use Committee. ΢Ȧ has an Animal Welfare Assurance (#A3607-01) on file with OLAW/NIH. ________________________________________ _______________ _____________ SIGNATURE DATE APPROVAL # SECTION 1. ADMINISTRATIVE Previous IACUC # New IACUC # 1. Principal Investigator: Phone:Emergency contact number:Box:  FORMTEXT      Email: 2. Project Title: 3. Purpose of Animal Use (check all that apply):  FORMCHECKBOX  Research/testing  FORMCHECKBOX  Teaching/training  FORMCHECKBOX  Sentinel animal use  FORMCHECKBOX  Breeding and colony management only; no experimental procedures  FORMCHECKBOX  Other. Please specify 4. Source of Funding:  FORMCHECKBOX  External funding (please specify source):  FORMCHECKBOX  New or competing renewal application  FORMCHECKBOX  Non-competing continuation of peer reviewed project  FORMCHECKBOX  Internal funding 5. Scientific or Educational Merit Review: If either of the following two situations apply, the ΢Ȧ Policy on Animal Care requires that there be an internal review for scientific (or educational) merit: you wish to begin the project prior to the reward of funding by an external funding agency the work is to be carried out with internal funds (i.e., without review for scientific merit by an external funding agency) Certification that the project has received internal review for scientific (or educational) merit requires the signature of your departmental chair in the box below. The signature of another reviewer designated by the chair is also required if the chair is directly involved in the project or judges himself/herself to be unqualified to assess scientific merit. The proposed project has been reviewed and the potential scientific/educational benefits justify the use of laboratory animals as described herein. __________________________ ________ Signature of Department Chair Date Signature of Designated Reviewer Date (if not department chair) Chairs Name (Print or type) Designated Reviewers Name (Print or type) SECTION 2. ANIMAL WELFARE 1. Study objectives (study aims) and rationale for use of animals. If this Application is associated with a submission for external funding, a copy of the research design component of the grant application must accompany this form. Please briefly describe the following in language that would be suitable for publication in a local newspaper (e.g., Providence Journal) Study/Instructional Objectives: Potential benefits for the health of humans and other animals: Justify the use of animals for the study or instructional exercise (vs. a computer model or in vitro methodologies) and the species selected, including favorable physiological/anatomical properties. The use of animals: The species selected: Please indicate why each of the covered (potentially painful or distressful) procedures cannot be replaced by one producing less potential pain or distress or one requiring the use of fewer animals. Please indicate why your proposed experiments/instructional protocols do not unnecessarily duplicate previous work. 2. Research Plan: For all projects or instructional exercises, summarize your research or instructional plan here in language understandable by scientifically trained but non-specialist members of the IACUC. Provide a clear and concise sequential description summary of all the procedures involving the use of animals that is easily understood by all members of the committee: A brief summary of each procedure that will be performed on live animals enrolled in this study (e.g. tail snips, surgery, stent placement, tumor induction, breeding, bleeding, metabolism procedures, behavioral studies, injections of chemical, biological agents and euthanasia.). If surgery is described, please make note and describe in detail in Appendix 4. Describe how the procedures relate to the aims of the project and the impact of the proposed procedures on the animals' wellbeing. If applicable, state whether multiple procedures will be performed in the same animals and whether blood or tissue will be taken on multiple occasions. Please use non-scientific terminology. Note: If you are seeking external funding for the experiments described in this protocol, cut and paste the abstract of that grant application and attach to this protocol a copy of the grant proposals research plan (including all descriptions of vertebrate animal use). Please assure consistency between this protocol and the grant proposal with respect to species, numbers of animals and procedures planned. Summary of Procedures: Personnel: List all individuals involved in this study/instructional exercise, their qualifications and relevant experience with the animal species used in this study and the procedures to be employed with these species. If these individuals have received animal welfare orientation/training with the consulting veterinarian, check the last box titled ACF. PersonnelResearch functionRelevant training/experience  Animal Subjects: List species and other relevant characteristics (strain, sex, size, age) of animals to be used. Please justify the choice of species AND number of animals to be used. How were the number of animals to be used for a project determined? A statistical analysis should be used to justify animal numbers whenever possible. Strain, stock, mutant, or breedSexAge/size*Special requirements *For each strain, stock, mutant, or breed listed, provide information about the required health status of the animals, surgical alterations or other special requirements. It is highly advisable that you discuss your special animal requirements with a consulting veterinarian before submission of this Application. Procedures: Check each Appendix that is required for the Application.  FORMCHECKBOX  Appendix 1-Antibody Production: If your experiments require the production of antibodies in animals housed in ΢Ȧ facilities, complete and attach.  FORMCHECKBOX  Appendix 2-Substances and Materials: If experimental substances or materials are to be administered to animals by injection, intubation, surface application or surgical implantation, complete and attach. All non-pharmaceutical grade substances must be scientifically justified.  FORMCHECKBOX  Appendix 3-Specimen Collection: If any body fluids, tissues, or devices are to be collected from animals pre- or post-mortem, complete and attach.  FORMCHECKBOX  Appendix 4-Surgery: If surgery is to be performed, complete and attach.  FORMCHECKBOX  Appendix 5-Special Husbandry and Procedures: If there are experimental or special husbandry procedures planned that are not described elsewhere in this Application, complete and attach. a. Location where Non-Surgical Procedures will be Performed: In the table below, indicate the sites where all non-surgical procedures will be performed. Be sure to include procedures such as radiography, fluoroscopy, computed axial tomography (CT), or magnetic resonance imaging (MRI) that may be performed outside the animal facility. Non-surgical procedureBuilding and room number Animal Transport: If animals are to be moved through public areas, including between buildings, describe the mode of transportation and measures taken to protect the animals and minimize public exposure. Controlled Substance: Indicate the Class (I, II, III, IV or V) of each controlled substance (narcotic or barbiturate) to be used. Describe the record system and security measures to be employed (this information is required by the U.S. Drug Enforcement Administration). Non-pharmaceutical grade substances: Researchers must use pharmaceutical-grade medications whenever they are available, even in acute procedures. Non-pharmaceutical grade chemical compounds should only be used in animals after specific review and approval by the IACUC for reasons such as scientific necessity or non-availability of an acceptable veterinary or human pharmaceutical-grade product. Regardless, all materials administered by parenteral routes, e.g., intravenous, intramuscular, intraperitoneal and intracranial, must be sterile; unless otherwise approved by the IACUC.  FORMCHECKBOX  ALL substances used are pharmaceutical grade  FORMCHECKBOX  Non-pharmaceutical grade substances WILL be used. If yes, describe preparation of each non-pharmaceutical grade drug (e.g. diluents, sterilization, pH balancing, storage and labeling). See HYPERLINK "http://grants.nih.gov/grants/olaw/faqs.htm" \l "useandmgmt_4" \t "_blank" http://grants.nih.gov/grants/olaw/faqs.htm#useandmgmt_4 for rationale and elaboration. Endpoint Criteria: The endpoint of an experiment is the stage at which the animal will be euthanized or otherwise removed from a study if the study is ongoing and utilizes animals which are maintained for a period of time before, during or after the study. Describe what criteria will determine that an animal has reached the endpoint of the study. Examples would include a weight loss limit as a percentage of initial or expected body weight (i.e. >15% weight loss), allowable durations of anorexia, allowable tumor size or total tumor burden expressed as a percentage of body weight, severe and unresponsive clinical problems or severe behavioral disturbances. If death (other than euthanasia) is the endpoint, justify why an earlier endpoint would not be acceptable. 7. Euthanasia: Describe the method of euthanasia for each animal: agent(s) used, dose (as applicable), and route of administration. Justify any method that is not considered acceptable by the 2013 AVMA Guide for Euthanasia. If you are unsure how to answer, contact our consulting veterinarian. Species AgentDose Route b. List the personnel who will perform euthanasia and indicate their training and experience with the method of euthanasia and the species involved. If personnel are not yet trained, indicate so and explain how they will be trained before performing euthanasia themselves. c. Describe routine disposal procedures for carcasses and contaminated material. d. Should a member of the animal care staff find that one of your animals has died, how should the carcass be handled (e.g. refrigerated or frozen), and should a member of your staff be contacted immediately? 8. USDA Animal Use Classification: (Each year the College must report animal use in these categories to the USDA). If more than one species is to be used, add a separate table for each species [copy and paste this table]. See the final section of this form for definitions to be used in this classification. Species: RatYear 1Year 2Year 3Category TotalUSDA Category BUSDA Category CUSDA Category DUSDA Category ETotal Numbers: YOU ARE RESPONSIBLE FOR KEEPING TRACK OF THE NUMBER OF ANIMALS USED PER YEAR. YOU WILL BE ASKED FOR THIS NUMBER ON THE ANNUAL RENEWAL FORM. 9. If animals are indicated in Category E, specify the procedure requiring this classification and supply a written scientific justification why analgesics, anesthetics or sedatives cannot be used. 10. If animals are included in Category D or Category E, the Animal Welfare Act requires that the Principal Investigator consult with the veterinary staff before initiating the experiments. Has this consultation occurred?  FORMCHECKBOX  Not Applicable  FORMCHECKBOX  Yes  FORMCHECKBOX  No. Please make appointment. 11. If animals are included in Category D or Category E, The Animal Welfare Act requires that investigators "consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals and provide a written narrative of the methods used and sources consulted to determine the availability of alternatives, including refinements, reductions and replacements." ProcedureSpeciesUSDA CategoryTotal # Animals (3y) The recommended approach is to perform one or more database searches to meet these mandates unless compelling justifications can be made for not doing so. Keep copies of computer database search results in your files to demonstrate your compliance with the law if regulatory authorities should choose to audit your project. The key words used in your search must include all potentially painful or distressful procedures (e.g. laparotomy, food restriction, etc., as well as the term 'alternatives'). Use a separate table for each procedure that may cause more than momentary or slight pain or distress. Procedure 1 _______________________________________ Database searchedDate performedYears coveredKey words and/or search strategy    Procedure 2 __________________________________________ Database searchedDate performedYears coveredKey words and/or search strategy    a. If you have used other sources of information (consultants, conferences, etc.) to meet this mandate, describe them here. SECTION 3. HOUSING AND HUSBANDRY 1. Housing Sites a. If some or all animals will be housed outside the animal facilities at ΢Ȧ, describe where they will be housed? If animals are to be removed from the Animal Care facility for experimental or teaching manipulations, indicate the building and room number where they will be located and if the animals will be returned to the Animal Care facility. 2. Husbandry a. Caging Needs: Please indicate the type of caging that you will need:  FORMCHECKBOX  Sterile rodent HEPA ventilated microisolators [Thoren Unit]  FORMCHECKBOX  Biohazard or other special hazard containment caging  FORMCHECKBOX  Metabolism cages  FORMCHECKBOX  Wire suspended cages  FORMCHECKBOX  Standard rodent shoebox caging with no filter top  FORMCHECKBOX  Standard non-rodent caging, appropriate for species  FORMCHECKBOX  Other. Describe:  FORMTEXT       b. If rodents are to be housed in cages with wire floors, justify why this type of housing is required and how the animals will be monitored for injury to their feet. If animals that normally live in social groups [e.g. rodents, primates, cats, dogs, ferrets, sheep, pigs] are to be housed singly, justify why single housing is required. If transgenic rodents are to be used in this study, are there any unique phenotype characteristics, husbandry requirements, clinical signs or behaviors to which the animal care staff need to be aware? If so, describe. SECTION 4. USDA GUIDELINES FOR ANIMAL USE CLASSIFICATION CATEGORY B. ANIMALS USED ONLY FOR BREEDING PURPOSES CATEGORY C. PROCEDURES INVOLVING MINIMAL, TRANSIENT OR NO PAIN OR DISTRESS. These procedures are considered to produce minimal, transient or no pain or distress when performed by competent individuals using recognized methods. Administration of anesthetics, analgesics, and tranquilizers Fluid and electrolyte therapy Immunizations, when not expected to cause more than minimal morbidity or distress Oral medications Non-chronic catheterization Blood collection, except transcardial and periorbital in species without an orbital (retrobulbar) sinus Gastric lavage Certain procedures performed in the normal practice of veterinary medicine or animal care (e.g. injections, palpations, skin scraping, ear punching, etc.) Hybridoma, when volume of fluid does not produce respiratory distress and paracentesis is performed only once Euthanasia as performed in accordance with recommendations of the AVMA Guidelines on Euthanasia. If the result of any of the above procedures may be considered painful or distressful, the procedure should be listed in Columns D or E, described below. CATEGORY D. PROCEDURES INVOLVING PAIN OR DISTRESS RELIEVED BY APPROPRIATE MEASURES. Examples of procedures that may produce pain or distress, but are performed using appropriate and adequate anesthesia, analgesia, or tranquilization and are followed with appropriate measures to alleviate pain or distress All forms of bleeding in which the animal is exsanguinated; orbital bleeding; intracardial blood collection All surgical procedures, including those associated with "acute" experiments performed under anesthesia from which the animal does not recover Injections of agents which cause morbidity or induce excessive inflammation or necrosis. The amount of pain or distress that results from the injection(s) of an irritating or noxious agent will depend on the agent used, the site of injection and volume injected, and the animal species. Animal users should use their own judgment when classifying their particular procedures. Base judgment on observation of the animal(s) and extrapolation of the causes of pain and distress in man Skin or corneal corrosivity testing Procedures requiring prolonged restraint of an animal (greater than 12 hours) Polyclonal antibody production with immunization via intradermal injection where inflammation is possible, especially with antigen booster injections Intracranial inoculations in animals with a fully ossified cranium CATEGORY E. PROCEDURES INVOLVING UNRELIEVED PAIN OR DISTRESS Procedures listed in Category D above must be listed in Category E if they are performed without appropriate and adequate anesthesia, analgesia, or tranquilizers or which are not amenable to relief by therapeutic measures. This would include assays that result in significant mortality, procedures resulting in moderate to severe morbidity, footpad inoculations, and the administration of drugs or irradiation which may cause toxicity. References:     IACUC # PAGE  Adapted from Brown University and RIH documents  PAGE 8 Application (updated: October 2014) APPROVAL # DEY ' 4 ! 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