WSU INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) PROTOCOL FOR ANIMAL RESEARCH AND/OR TEACHING ACTIVITIES PURPOSE It is recognized that the use of live animals is an integral part of the educational and research missions of WSU. All faculty, students and staff engaging in research, research training (including teaching), experimentation, biological testing and related activities (including classroom demonstrations) involving live, vertebrate animals housed in campus facilities or in/from the wild are required to submit a Protocol for Animal Research and/or Teaching Activities prior to initiating such activities. Purely observational field studies, which do not involve invasive procedures, harm to the animals, or materially alter the behavior of the animals, do NOT require a protocol. For additional information, refer to the WSU Regulation 3-32 Assurance of Compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals at http://www.winona.edu/faculty/3-32.pdf. The Policy addresses the entire institutional program of animal care and use, covering animals used in both research and teaching activities. For regulatory information, refer to the most recent copies of: PHS Policy on Humane Care & Use of Laboratory Animals; Animal Welfare Act (CFR Title 9, Chapter 1. Subchapter A, Parts 1, 2 and 3); Guide for the Care and Use of Laboratory Animals (National Research Council); American Veterinary Medical Association (AVMA) Panel on Euthanasia IACUC REVIEW The IACUC reviews protocols in accord with two general goals: 1. Scientific reliance on live animals should be minimized. 2. Pain, distress, and other harm to laboratory animals should be reduced to the minimum necessary to obtain valid scientific data. The Protocol form is designed to allow for the use of live animals in education and research while ensuring that regulatory requirements are met. The form provides the IACUC with the necessary information to determine if the use of animals is justified and pain and distress is justifiable given the nature of the activities. It is also designed to determine if animals housed on campus will receive appropriate care. ANIMAL FACILITIES The approved permanent facilities on campus for mammals and birds are Stark 219 and Phelps 208A. Mammals and birds may be removed from these facilities for research and teaching activities for no longer than twelve (12) hours. Other vertebrates (e.g. amphibians, reptiles and fish) may be housed in other rooms on campus subject to inspection of the facilities by the IACUC. ANIMAL CARE Ultimate responsibility for the care of any animal rests with the Principal Investigator (PI), who shall name another Faculty Designee to be approved by the IACUC. This Designee will assume responsibility for the care of the animals upon the absence of the PI. If the IACUC receives a report of animals not receiving appropriate care and determines to the best of its ability that said care is inadequate, the IACUC will assume control of the animals and may care for or dispose of the animals, up to and including euthanasia, as appropriate. IACUC emergency / notification procedures are included in an attachment to the IACUC Protocol form and are updated annually. INSTRUCTIONS Complete each item on the Request Form. If an item is not applicable, please indicate this with a response of “NA”. Do not leave any items blank. Attach additional pages or supporting documentation as needed. Submit seven (7) copies to the Grants & Sponsored Projects Office, Maxwell 161. Requests will be forwarded to the full IACUC for review at the next scheduled monthly meeting. Note: The IACUC does not review requests during summer break. DECISIONS The IACUC is a federal regulatory board reporting directly to the President. A protocol approved by the IACUC may be disapproved by the President. However, a Protocol disapproved by the IACUC cannot be approved by the President nor any other administrative office on campus. An investigator whose protocol is disapproved by the IACUC will receive written suggestions for modifying his/her request and may revise and resubmit the protocol and/or request a meeting with the IACUC to present a further rationale for approval. Research and/or teaching activities involving animals may not be initiated prior to receiving IACUC approval and the IACUC may advise the President to suspend any unauthorized activities or activities found to be in violation of the WSU Assurance. Rev. 8/30/07 -- Page 1 of 7 WSU IACUC PROTOCOL FOR ANIMAL RESEARCH AND/OR TEACHING ACTIVITIES I. BACKGROUND INFORMATION Note: Students must identify a faculty advisor. Attach additional sheets if needed. A. Investigator/Project Director Department Mailing Address email Faculty Advisor Phone B. Co-Investigator Department Mailing Address email Faculty Advisor Phone Co-Investigator Department Mailing Address email Faculty Advisor Phone Phone Phone Phone C. For projects which involve (or may involve) external funding: 1. Will a proposal for support for this project be submitted to a funding agency? Yes No 2. Name and address of person at funding agency and/or other cooperating institution(s) who should receive notice of WSU IACUC approval (other than the Principal Investigator). NOTE: Copies of proposals submitted to external agencies must be attached to this protocol. D. Project Title (Include Proposal Title for externally-funded activities if different.) E. Inclusive dates of project to F. Identification of species and number of animals to be used 1. Species: 2. Common name: 3. Source (name of licensed or authorized vendor or breeder, or indicate if bred in-house): 4. Total number of animals: G. Project Category – See Following page for category descriptions. A. (no longer in use) B. C. D. E. Page 2 of 7 WSU IACUC PROTOCOL FOR ANIMAL RESEARCH AND/OR TEACHING ACTIVITIES The following project category definitions are adapted from the United States Department of Agriculture (USDA) classifications and examples. Classification A: This category is no longer in use. Classification B: Animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery, but not yet used for such purposes. Examples: Breeding colonies of any animal species that are held in legal sized caging and handled in accordance with the Guide for the Care and Use of Laboratory Animals and other applicable regulations. Breeding colony includes parents and offspring. Newly acquired animals that are held in proper caging and handled in accordance with applicable regulations. Animals held under proper conditions or wild animals that are being observed. Classification C: Animal upon which testing, research, experiments, or tests will be conducted involving no pain, distress, or use of pain-relieving drugs. Examples: Procedures performed correctly by trained personal such as administration of electrolytes/fluids, administration of oral medication, blood collection from a common peripheral vein per standard veterinary practice or catherization of same, standard radiography, parenteral injections of non-irritating substances. Euthanasia performed in accordance with the recommendations of the most recent American Veterinary Medical Association (AVMA) Panel on Euthanasia, utilizing procedures that produce rapid unconsciousness and subsequent humane death. Manual restraint that is no longer than would be required for a simple exam. Classification D: Animals upon which experiments, teaching, research, surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drug will be used. Examples: Surgical procedures conducted by trained personnel in accordance with standard veterinary practice such as biopsies, gonadectomy, exposure of blood vessels, chronic catheter implantation, laparotomy or laparoscopy. Blood collection by more invasive routes such as intracardiac or periorbital collection from species without a true orbital sinus such as rats and guinea pigs. Administration of drugs, chemicals, toxins, or organisms that would be expected to produce pain or distress but which will be alleviated by analgesics. Classification E: Animals upon which teaching, experiments, research, surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs will adversely affect the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. Examples: Procedures producing pain or distress unrelieved by analgesics such as toxicity studies, microbial virulence testing, radiation sickness, and research on stress, shock, or pain. Surgical and postsurgical sequella from invasion of body cavities, orthopedic procedures, dentistry or other hard or soft tissue damage that produces unrelieved pain or distress. Negative conditioning via electric shocks that would cause pain in humans. Note: Protocols for classification E activities must provide a scientific justification to explain why the use of anesthetics, analgesics, sedatives or tranquilizers during and/or following painful or distressing procedures is contraindicated. Page 3 of 7 WSU IACUC PROTOCOL FOR ANIMAL RESEARCH AND/OR TEACHING ACTIVITIES II. Animal Care At WSU, individual researchers and/or faculty advisors are responsible for the care of the animals used in research and teaching activities. All animals on campus will be housed following standards set forth in the Public Health Service (PHS) Policy which complies with the Guide for the Care and Use of Laboratory Animals and the U. S. Department of Agriculture (USDA) Animal Welfare Act. Specific guidelines for lower vertebrates (e.g. fish, amphibians and reptiles) are not set forth in the Guide nor the Animal Welfare Act. Investigators are to adhere to guidelines for the care of these vertebrates established by appropriate professional associations. Activities may not involve species covered by the U.S. Department of Agriculture’s definition of animal. A. Housing 1. Primary Housing location (Mammals and birds must be housed in Stark 219 or Phelps 208A): Stark 219: Phelps 208A: Specify locale for animals other than mammals or birds: 2. If animals will be removed from primary housing area for research or teaching activities, identify: Alternate location: How often the animals will be transported to that location: How long (at each occurrence) will the be kept at that location: B. Care standards and responsibilities 1. Standard feeding Standard water Standard housing Yes Yes Yes No (Explain in activities description.) No (Explain in activities description.) No (Explain in activities description.) 2. Identify by name the individual responsible for the following activities: Principal investigator (PI) Or faculty advisor Student/staff under PI/Faculty direction Arrangements for veterinary care Bedding (changing and disposal) Sanitation (cage and facility cleaning) Waste disposal (waste products/trash) Temperature/ventilation monitoring Daily observation and care for animals Providing for weekend and holiday care 3. Identify the Faculty Desigee who will care for the animals when the PI is not on campus and explain what arrangements have been made for 24-hours-a-day care when the PI is not contractually obligated to be on campus. Page 4 of 7 WSU IACUC PROTOCOL FOR ANIMAL RESEARCH AND/OR TEACHING ACTIVITIES III. ACTIVITIES DESCRIPTION Attach a narrative addressing each of the following questions. Purpose: What is the purpose of the research or teaching activities? Provide a 2-3 sentence description of the research objectives. Unnecessary duplicative research/activities should be avoided. Research design: Provide a complete description of the experimental design, including descriptions of experimental injections or inoculations, blood withdrawals, surgical procedures, radiation doses, methods of restraint and/or other possible stresses (e.g. food or water deprivation, environmental stresses, etc.). Provide citations for any supporting literature. If using vertebrates in the wild (field study), describe any state or federal permits required, agency issuing and/or holding the permit(s) and date(s) they were obtained. (The term field study does not include observational studies which do not involve invasive procedures, harm to the animals, or materially alter the behavior of the animals. Protocols are not required for observational studies.) Justification: What is your rationale for using animals? Explain why a non-animal model, such as cell or tissue cultures or computer simulations or other training aids, is not appropriate. Species selection: Why is this species the most appropriate selection? The species should be the lowest possible on the phylogenetic sale. Number of animals: How did you determine the number of animals to be used? The number of animals should be the minimum required to obtain statistically valid results. Provide statistical justification, if possible. Timely intervention: Identify the criteria and processes for intervention and removal of animals from a study. Minimization of pain and distress: What procedures will be taken to minimize pain and distress? Provide citations for any supporting literature. Anesthesia, analgesia, tranquilization or other agents: Identify agents to be used as part of the experimental design and/or euthanasia, if appropriate. Specify dosage and method of administration. If using a controlled drug, describe security and tracking procedures and identify any state or federal permits required, agency issuing and/or holding the permit(s) and date (s) they were obtained Post research care: Euthanasia: Provide a complete description of the method of euthanasia to be employed. Investigators should adhere to the 2000 guidelines of the American Veterinary Medical Association (AVMA) Panel on Euthanasia. If you require an exception to the AVMA guidelines, provide a justification with literature citations along with your protocol. Briefly describe carcass disposal procedures. Maintenance: If animals will be maintained in WSU facilities after the conclusion of the study, indicate how they will be cared for. Other: Please specify provision for care. Note: It is understood that following a field study animals will be released. Page 5 of 7 WSU IACUC PROTOCOL FOR ANIMAL RESEARCH AND/OR TEACHING ACTIVITIES IV. QUALIFICATIONS, EDUCATION AND TRAINING, AND SAFETY MEASURES A. Qualifications Describe the training and experience of the PI and Co-Investigator(s) as it relates to the care and handling of the species of animal to be used and the experimental procedures to be undertaken. If a self-instructive training program has been completed, please identify the instructional source. B. Education and Training 1. Describe the education and training that will be provided to students who are conducting research. 2. Please indicate which of the following will be addressed in the training program. Note that depending on the species of animal or the amount of animal exposure, not all areas will be applicable. pre-placement medical evaluation identification of hazards to students and safeguards appropriate to the risks appropriate testing and vaccinations training of students regarding their duties, hazards and safeguards policies and facilities that promote cleanliness provisions for treating and documenting injuries and illnesses C. Hazardous agents: Identify any hazardous agents (radionuclides, biological agents, hazardous chemicals or drugs, recombinant DNA, etc.). Describe any state or federal permits required, agency issuing and/or holding the permit(s) and date(s) they were obtained. Describe how and when the the WSU Safety Officer will be notified of potential hazardous waste disposal. D. Safety Measures Identify any potential risks and/or hazards (to researchers, students or staff) and identify the procedures to be followed to mitigate such risks. Page 6 of 7 WSU IACUC PROTOCOL FOR ANIMAL RESEARCH AND/OR TEACHING ACTIVITIES Protocol number (to be assigned by the IACUC): _________________ V. Certifications A. Investigator(s) Certification Any significant changes in this approved protocol must receive prior approval of the IACUC. The investigator(s) are responsible for the animals under her/his care and must notify the IACUC of any unanticipated impact on the animals. Any unanticipated pain, distress, morbidity or mortality should be reported to the IACUC. The IACUC may request periodic documentation that no changes have occurred. 1. Project Title (include Proposal Title for externally-funded activities if different.) 2. Investigator signature ______________________________ Date:___________________ Co-Investigator(s) signature(s): ______________________________ Date:___________________ Co-Investigator(s) signature(s): ______________________________ Date:___________________ Faculty Advisor signature: ______________________________ Date:___________________ 3. Faculty Designee: By signing below, I indicate my agreement to assume responsibility for the care of the animals covered by this protocol in the event of the absence of the PI. Faculty Designee: ________________________________________ Date:____________________ B. IACUC Certification -- This certifies the action(s) taken by the WSU IACUC on the above Protocol. Provides an unqualified approval. Defers a decision for the reasons described below. Approves the protocol pending clarification as described below. Provides a qualified or conditional approval pending satisfaction of conditions described below. Provides a limited approval as described below. Disapproves your protocol based on the rationale provided below. Explanation for above decision IACUC Chair signature: ___________________________________________ (designee) Date: __________________ Page 7 of 7 INSTITUTIONAL ANIMAL CARE & USE COMMITTEE EMERGENCY / NOTIFICATION PROCEDURES Contact information for the Principal Investigator (PI), his/her Faculty Designee and the required protocol information must entered below and this sheet must be conspicuously posted on the animal enclosures so as to clearly identify the animals within.. Protocol number: Species --------------------------------------------------------------------------------------------------------------------------------------Any individual who questions whether these animals, covered by the protocol number given above, are in an emergency situation and/or are not receiving adequate care should notify the individuals below in the order given. If the IACUC receives a report of animals not receiving appropriate care and determines to the best of its ability that said care is inadequate, the IACUC will assume control of the animals and may care for or dispose of the animals, up to and including euthanasia, as appropriate. Contacts in order Day phone Evening/weekend Mobile phone phone email 1. Principal Investigator 2. Faculty Designee 3. Any IACUC member Richard Deyo Mark Garbrecht John Holden Robin Richardson 457-5667 457-2261 457-5439 457-5128 608.781.1590 --608.799.4137 rdeyo@winona.edu Mgarbrech@!winona.edu Jholden@winona.edu rricharson@winona.edu Exception Nothing in this emergency contact procedure shall prohibit an individual from contacting an IACUC member directly without notifying the PI or the Faculty Designee if she/he believe such actions are in the best interests of the animals.