Protocol for Approval of Activities Involving the Use of Laboratory Animals Office of Research Compliance 309A University Hall Bowling Green State University Bowling Green, OH 43403 419-372-7716 Read but Do Not Submit the First Page of this Application The attached protocol form is to be used when requesting review by the Bowling Green State University Institutional Animal Care and Use Committee (IACUC) for approval of research/teaching/display activities involving vertebrate animals. This information is required by NIH under Section 2F, Vertebrate Animals, and by the USDA effective October 30, 1989, per A.P.H.I.S., Final Rules Pertaining to the Animal Welfare Act. Approved protocols will be periodically monitored to ensure compliance. Please be thorough and explicit. Failure to respond to all the requested items, to submit all appropriate documents, or to obtain all required signatures will result in a delay in reviewing your application. The information contained in this protocol form may become publicly available either through the open records act or through open meetings. Each type of activity requires a separate protocol and response. Although more than one species may be included in a single protocol, each species will require its own independent narrative. Once this form is completed it: Should be previewed by the University Animal Facilities Director, Jenifer Baranski (jbarans@bgsu.edu). Must be reviewed by the Attending Veterinarian, Dr. Susan Orosz (drsusanorosz@aol.com) prior to IACUC review. Notification of approval by the Attending Veterinarian must be communicated to the Office of Research Compliance prior to the meeting at which the protocol will be reviewed. If this project includes any activities involving the use of recombinant DNA it must also be submitted to Scott Rogers (srogers@bgsu.edu), BGSU’s Institutional Bio-Safety Committee (IBC) Chair. Approval by the Biosafety Committee must be communicated to the ORC prior to the meeting in which the protocol will be reviewed. Remember to: Take the appropriate online training. Instructions can be found at the “Researcher Training” link at: http://www.bgsu.edu/offices/orc/iacuc. For in-person euthanasia training, contact the UAF Director (jbarans@bgsu.edu; 3728753). Sign the protocol before submitting. Deliver the original signed hard copy and any supporting documents (literature search specifics, grant proposals, etc.) to the IACUC c/o Office of Research Compliance, 309A University Hall. Email the electronic copy of the protocol and supporting document to the IACUC c/o hsrb@bgsu.edu. Both the hard copy and the electronic versions must be sent to the ORC by the submission deadline, which can be found at the IACUC's Meeting Calendar web page. Institutional Animal Care and Use Committee (as of September, 2013) http://www.bgsu.edu/offices/orc/iacuc Bowling Green State University Animal Research & Teaching Laboratory Protocol as of September, 2013 1. Title: 2. Principal Investigator: 3. Protocol participants who will be working with live animals [AWA 2.32] **Note: if online training has not yet been completed, see the IACUC website for training instructions (http://www.bgsu.edu/offices/orc/iacuc). Name Investigator Protocol # University / Dept. Level (Faculty, Staff, Graduate Student, etc.) Protocol Activities to be Performed For ORC Use Only #1-13 requires online training completion**. #13 Requires Euthanasia Training (contact University Animal Facilities) 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Observation Animal Handling Animal Husbandry Behavioral Testing Trapping / Tagging Disease Treatment Injections / Fluid Withdrawals Tissue Sampling Anesthesia Perfusion Non-Survival Surgery Survival Surgery Euthanasia 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Observation Animal Handling Animal Husbandry Behavioral Testing Trapping / Tagging Disease Treatment Injections / Fluid Withdrawals Tissue Sampling Anesthesia Perfusion Non-Survival Surgery Survival Surgery Euthanasia 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Observation Animal Handling Animal Husbandry Behavioral Testing Trapping / Tagging Disease Treatment Injections / Fluid Withdrawals Tissue Sampling Anesthesia Perfusion Non-Survival Surgery Survival Surgery Euthanasia 1 Bowling Green State University Animal Research & Teaching Laboratory Protocol as of September, 2013 Name Investigator Protocol # University / Dept. Level (Faculty, Staff, Graduate Student, etc.) Protocol Activities to be Performed For ORC Use Only #1-13 requires online training completion**. #13 Requires Euthanasia Training (contact University Animal Facilities) 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Observation Animal Handling Animal Husbandry Behavioral Testing Trapping / Tagging Disease Treatment Injections / Fluid Withdrawals Tissue Sampling Anesthesia Perfusion Non-Survival Surgery Survival Surgery Euthanasia 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Observation Animal Handling Animal Husbandry Behavioral Testing Trapping / Tagging Disease Treatment Injections / Fluid Withdrawals Tissue Sampling Anesthesia Perfusion Non-Survival Surgery Survival Surgery Euthanasia 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Observation Animal Handling Animal Husbandry Behavioral Testing Trapping / Tagging Disease Treatment Injections / Fluid Withdrawals Tissue Sampling Anesthesia Perfusion Non-Survival Surgery Survival Surgery Euthanasia 2 4. Description of project a. Please provide a brief (1-2 sentences) overall summary description of the proposed project in the box below: Insert Text Here b. Please check all of the categories below that describe the type of animal use proposed in this protocol. Applied Research Basic Research Field Research Instruction/Training/Teaching Testing (toxicology, etc.) Service (breeding, antibody production, etc.) Other (Please Describe) c. The proposed work is part of: an inferential study, with a specified statistical power where conclusions are to be made about a population based on information obtained from a sample. The optimal sample size should be determined by statistical procedures. an exploratory/descriptive study that examines patterns and relationships of responses; conclusions are often less definitive than in an inferential study. Sample size often is determined by previous experience, past practice, and/or statistical rules of thumb. a pilot/feasibility study that is a small-scale investigation to test the feasibility of methods and procedures in preparation for a definitive larger-scale study. The results often can be used to aid in determining optimal sample size for future inferential studies. an animal breeding or surveillance protocol that does not test experimental hypotheses. a teaching protocol that is intended to demonstrate scientific concepts. 5. Identify the animals to be used in this research [AWA 2.31(e)(1)] Identify the species, strain and total number of animals that will be during the life of the approved project and list the number of offspring that will be generated. Species Strain or common name Total Number (include offspring separately) Investigator Protocol # Office Use Only USDA Category 3 6. List any special housing or special needs this protocol will require If you are requesting that animals be single housed or other forms of enrichment withheld, you must scientifically justify this in the text below. Insert Text Here 7. Experimental/instructional procedures From the list below, check all experimental or instructional procedures that will be performed on the animals requested in this application. All procedures checked below must be explained in question #12 (Experimental Manipulations). Check all that apply. Level 1 training Animal Handling Observation only (no manipulations) Animal Husbandry Other (specify) Level 2 training Addiction or addiction withdrawal Behavior Modification/Operant Conditioning Blood Collection Capture of Wildlife Environmental Manipulation Gavage Immunosuppression Inoculation, experimental Lavage Obesity, experimental Sensory Dysfunction Tissue Sampling Trapping/Tagging Antibody Production Biopsy Breeding Disease Treatment Food/Fluid Restriction Immunization, experimental Injection/Fluid Withdrawal Irritation, experimental Noxious Stimulus Restraint Stress Toxicity Test Other (specify) Level 3 training Amputation Ascites Production Cannulation Cardiac Puncture Euthanasia Injury/trauma Anesthesia Burn Catheterization Dental Procedure Implant Irradiation Investigator Protocol # 4 Myocardial Infarction Paralysis, experimentally induced Peritoneal Lavage Sepsis Induction Stun Surgical Procedure, Recovery Tumor Growth, experimental Organ Failure/Dysfunction, experimental Perfusion Radiography Stroke Surgical Procedure, Non-recovery Transplantation Other (specify) 8. Provide a lay language (non-scientist, high school level) description of the proposed work. . Note – if this explanation is not in LAY LANGUAGE this WILL delay approval of this protocol. Please provide a brief description of the work to be performed. Include the overall goal, and how the work will benefit society, and/or human or animal health, and/or the advancement of knowledge. Avoid technical language and most or all experimental details. These summaries will represent your project, and be released upon request, to media reporters, animal welfare activists, concerned citizens, etc. Insert Text Here 9. Explain why animals must be used for this work, and provide justification for any procedures which may cause harm or discomfort to the animals [AWA 2.31(e)(2)]. In particular, address whether it would it be possible to conduct the work on human subjects, tissue cultures, or by using computer simulations or inferences based on extant data. Insert Text Here 10. Why have you chosen this particular species for the proposed work [AWA2.31(e)(2)]? For example, does this species have particular biological characteristics which are important for the work? Is it that this species has been used by others in providing the groundwork? Insert Text Here 11. Provide a description of the relevant expertise of the PI and team members in relation to the species of animals and experimental techniques which will be used [AWA 2.31(d)(1)(viii), 2.32], [PHS Policy IV.C.1.f]. Describe which researcher will be performing each activity/procedure. If the proposed species and/or experimental techniques have not been previously used by any person listed on the protocol, explain how appropriate training will be obtained and who will provide the training. Investigator Protocol # 5 Insert Text Here 12. Procedures: Provide a clear outline of the work to be performed and justify the number of animals to be used. [AWA 2.31(e)(2),(3)] 12a. Address the following points: Briefly describe the rationale (goal) for each experimental group. Tables or flow charts that detail the use of the animals can be very helpful and are encouraged. Describe each aspect of the project for each group, and each procedure to be performed in detail (e.g., observing, tagging, injecting, surgery, training, food deprivation, special diet, transport, special housing, special lighting, etc.). o For behavioral tasks give a description of the apparatus, number of trials, length of session, transport to/from session, etc. o You can list alternate treatments or forms of substances that may need to be used if the preferred treatment does not work. o If you are proposing to use food or water deprivation you must include procedures for: Determining the target weight for each animal, Recording the weight for every animal every day, Administering the correct amount of food (or water) each day, Daily recording of the amount and time of food (water) delivery, Posting of the weight and feeding records in an easily visible spot on the colony room wall. Insert Text Here 12b. Address the following points: Give an itemized account of all animals to be used in all aspects of the experiment (e.g., number of animals per group/per experiment). Note that this accounting must agree with the numbers given in Item 5 above. Justify the number of animals to be used in each case (e.g., describe the population variance in relation to the planned statistical analyses, attrition due to loss of subject/preparation, etc.). Insert Text Here 13. Will surgery be performed? [AWA 1.1, 2.31(d), 2.33(b)] Investigator Protocol # 6 No - Go to item 16 Yes - Continue with item 14 14. The following questions are in regards to surgery. NOTE – A complete description of the surgical procedure, in detail from pre-operative procedures through to recovery including monitoring/documentation procedures must be included in item 12 above. 14a. Location of surgery (room number): Insert Text or "N/A" Here 14b. List the surgical and recovery team along with their qualifications. Insert Text or "N/A" Here 14c. Detail arrangements for handling of post-operative complications, include after-hours, weekend and holiday care. Insert Text or "N/A" Here 15. Special consideration must be taken when a single animal undergoes multiple surgical procedures [AWA 2.31(d)(1)(x)]. Use the following questions to clarify the use of multiple surgeries in this protocol. 15a. Will multiple surgeries be performed on the same animal? No – Go to item 16 Yes – Continue with item 15b 15b. Justify scientifically the necessity for using the same animal in multiple surgical procedures: Insert Text or "N/A" Here 15c. Indicate the minimum interval of time between procedures: Insert Text or "N/A" Here 16. List potential adverse consequences and/or complications in this research and associated remedial actions. Investigator Protocol # 7 Describe any adverse consequences and/or severe complications that may be seen as a result of this research. Provide any remedial action that will be taken to counteract consequences and complications (examples: loss of appetite, post-operative discomfort and/or infections, wound complications, selfinflicted or cage-mate-inflicted injury, anesthetic death, etc.). Insert Text or "N/A" Here 17. Early removal criteria List early removal criteria (such as particular animal behaviors, observations made by investigators, etc. that would be signs indicating the need for early removal). This will enable a prompt decision to be made by the Attending Veterinarian, Animal Facilities and the PI to ensure that the end point is humane and the objective of the protocol is achieved. Insert Text or "N/A" Here 18. Identify the appropriate medication (e.g., sedative, analgesic or anesthetic) that will be used. If withholding such agents is necessary for scientific reason, please provide justification and the necessary period of time that the medication would be withheld. Insert Text or "N/A" Here 19. Alternatives [AWA 2.31(d)(1)(ii)] For any procedure that might potentially cause more than momentary or slight pain and distress to the subject animals, the principal investigator MUST answer questions 1-9 in this section AND provide a written narrative description of the methods and sources used in the attempt to find alternate methods or procedures which are less painful or distressful to the subject animals. Database searching is the most effective and efficient method for determining whether or not alternatives are available. There is no one database that reviews all the literature in all research fields. A thorough search will require searching multiple databases. Listed below are some (but not all) relevant databases. AGRICOLA (10) ASFA (44) A-V Online (46) Biological Abstracts BIOSIS (5) CAB Abstracts (50) Education Abstracts (437) Ei Compendex (8) EMBASE (73) FEDRIP (266) International Pharmaceutical Abstracts (74) Investigator Protocol # Life Sciences Collection (76) MathSciNet (239) MEDLINE (155) Microcomputer Index (233) NTIS (6) Pascal (144) Pharmaceutical News Index (42) PsycINFO (11) RTECS (336) SciFinder Scholar [Chemical Abstracts] (399) ISI Science Citation Index 8 ToxFile (156) Zoological Record (185) Note: Protocol approval is often delayed because of insufficient or poorly constructed database searches. It is strongly suggested that you consult with a reference librarian regarding your search. For assistance in formulating your search strategy, or in conducting the database searches, please contact the Reference Librarian at the Ogg Science Library, Bowling Green State University (419-372-2591). The written narrative must summarize the results of the database searching and include: 1. The names of the databases searched. Insert Text or "N/A" Here 2. The date the search was performed. Insert Text or "N/A" Here 3. The period covered by the search. Insert Text or "N/A" Here 4. The key words and search strategy (The logical keyword combinations, along with the search operators that were used to combine the keywords, such as “AND”, “OR”, “NOT”, “ADJ”, “NEAR”, “SAME”, “WITH”, etc.) used. Also include the search results, the number of “HITS” you received for the search terms used. In some databases this information is available as a “search history” that can be printed with the results. Be sure to use words such as “alternative” or “model” in your search. Insert Text or "N/A" Here 5. Any alternatives to live animals such as mathematical models, computer simulations or in vitro biological systems, appropriate for the study, that were discovered through the database searching. Insert Text or "N/A" Here 6. Discussion of using a lower-order animal. If it would be possible to replace one species with another not as high on the phylogenetic scale, supply justification for not using this lower-order model. Insert Text or "N/A" Here 7. Discussion of whether the search results showed a reduction in the number of animals used would be possible. Insert Text or "N/A" Here 8. Discussion of whether the search results showed any procedural refinements that would lessen the pain or distress in the subject animals. Investigator Protocol # 9 Insert Text or "N/A" Here 9. Justification as to why a bona fide alternative method was not used, if an alternative method or procedure was identified, and if it could have been used to accomplish the goals of the animal use proposal. Insert Text or "N/A" Here Please provide a narrative in the text box below and attach the “search strategy” or “search history” to the back of the signed protocol form. (Note: If the study does not have the potential to cause more than momentary or slight pain and distress to the subject animal you must state this. Do NOT leave this item blank.) Insert Text or "N/A" Here 20. Unnecessary Duplication – Provide either: A. Written assurance (in the box below) that the proposed activities do not unnecessarily duplicate previous research/experiments/testing conducted by this PI’s lab or by any other investigator. Explain how you determined that these activities are not duplicative of previous work. Methods for determining that there is no unnecessary duplication include, but are not limited to: a) A literature search b) A description of recent peer review of the work, such as that which may have been provide by a federal granting agency or at a formal presentation to colleagues. c) Communications with relevant subject experts. Insert Text or "N/A" Here OR B. If the proposed activities do duplicate previous work, justify the need for this duplication in the box below (e.g., teaching protocols reviewed on a by-student basis where the learning experience is not available at this institution in any other course). Insert Text or "N/A" Here THEN If your assurance is based upon a literature search, please provide the following (and attach the search history to the back of the signed protocol form): Investigator Protocol # 10 1. The names of the databases searched. Insert Text or "N/A" Here 2. The date the search was performed. Insert Text or "N/A" Here 3. The period covered by the search. Insert Text or "N/A" Here 4. The key words and search strategy (The logical keyword combinations, along with the search operators that were used to combine the keywords, such as “AND”, “OR”, “NOT”, “ADJ”, “NEAR”, “SAME”, “WITH”, etc.) used. Also include the search results, the number of “HITS” you received for the search terms used. In some databases this information is available as a “search history” that can be printed with the results. If any truncation or wildcard characters were used, field qualification (searching only in the article title, abstract, etc.), or limits applied, include this information. Insert Text or "N/A" Here If your assurance includes communications with subject experts, provide the following [and attach any relevant hard copy documentation (e-mails, letters, etc.)]: 5. The date of the communication. Insert Text or "N/A" Here 6. The name of subject expert. Insert Text or "N/A" Here 7. The subject expert’s qualifications and relevance to the proposed work. Insert Text or "N/A" Here 8. The amount of time spent in consultation regarding the proposed work. Insert Text or "N/A" Here 9. A summary of your communication with the expert. Insert Text or "N/A" Here 21. What will happen to the animal(s) at the end of this study? Investigator Protocol # 11 21a. If the animal survives the end of the study, what will happen to it? Adoption Euthanasia Protocol transfer (if possible identify protocol(s) here Release (describe here ) Other (describe here ) ) 21b. If the death of the animal is part of the protocol or necessary for other reasons, list the method of euthanasia for each species to be used in this protocol [AWA 2.31(d)(1)(xi), 2.31(e)(1)], [PHS Policy IV.C.1.g]. See the 2007 AVMA Guidelines on Euthanasia for information regarding methods of euthanasia (http://www.avma.org/issues/animal_welfare/euthanasia.pdf) Animal/Species Method Agent Dose (mg/kg) Route of Administrations 21c. How will death be determined? (List a primary and secondary means – see Euthanasia SOP-160 at http://www.bgsu.edu/downloads/gradcol/file45043.pdf) Insert Text or "N/A" Here 22. Will animals be caught in the wild? No - go to item 23 Yes - describe the capture methodology to be used, then continue with question 22a Insert Text or "N/A" Here 22a. Have appropriate collection permit(s) been obtained? This includes local permits which grant access to property. No – Obtain permit(s) and provide a copy of the permit(s) to the Office of Research Compliance Yes – Attach a copy of the permit(s) to the protocol N/A Investigator Protocol # 12 23. Will animals be transported from the wild or from another institution to BGSU? No – go to item 24 Yes – provide the details of the transport below, including the precautions used to ensure animal health and welfare. Then go to item 23a. Insert Text or "N/A" Here 23a. Have necessary transportation permits been obtained? No – Obtain permit(s) and provide a copy of the permit(s) to the Office of Research Compliance Yes – Attach a copy of the permit(s) to the protocol N/A 24. Are any hazardous materials (biological, chemical, radioactive) used in conjunction with this protocol? No Yes - (complete the table and sign-off section below) For each hazardous material that is given to the animals (whether or not they are subsequently housed in the UAF), list the following information in the table below: Agent 1 Agent 2 Agent 3 Hazardous Agent Type of Hazard Amount administered Route of administration Duration of exposure of animals Will the hazard be brought into UAF (Yes/No) How will hazard be stored? How will hazard be prepared? Will the hazard be excreted or shed by animals while they are Investigator Protocol # 13 housed in the animal facility? (Yes/no) Duration of hazard in UAF 25. Assurance by Principal Investigator I certify that this project will be conducted in full accordance with the PHS Policy on Humane Care and Use of Laboratory Animals, the Animal Welfare Act and Regulations, and Bowling Green State University policies governing the use of live vertebrate animals for research, testing, or teaching purposes. I understand that institutional approval is valid for a period of three (3) years following the date of original approval with annual updates required. At the end of the three (3) year period, this protocol shall be automatically inactivated and all animal activities covered under it shall cease. To continue or add to these animal activities, submission and review of a new animal use protocol is required. The new protocol will be assigned a new protocol number. Should any changes occur (e.g., increase/decrease in number of animals, change of technique, additional co-PI, etc.), I accept the responsibility to submit an appropriate modification to IACUC for review prior to initiation of such changes or modifications. I will keep a copy of the approved protocol and any associated approved addendum requests in relevant animal housing and procedure rooms I affirm that the information presented in this protocol accurately reflects the animal use in any associated grant application submitted for either internal or external funding. This research protocol will be reviewed in an open meeting and the information contained herein may become otherwise publicly available under the open record act. If you feel that all or part of your protocol is properly confidential, i.e., is: potentially patentable work, trade secrets, proprietary information, work that could lead to or result in commercial development, or (perhaps) other information related to your research which you deem to be confidential, you may wish to have the protocol considered confidentially. If you decide to request that the protocol be considered confidentially, do not sign this signature page. Instead, ORC will provide, upon request, an alternate signature page for protocols containing confidential information. If this protocol involves the use of hazardous materials, I agree that all procedures involving the storage, handling, use, and/or disposal of these materials will be performed in compliance with BGSU’s: Hazardous Waste Manual: http://www.bgsu.edu/offices/envhs/page18352.html Institutional Biosafety Committee Guidelines: http://www.bgsu.edu/offices/orc/ibc Radiation Safety Program: http://www.bgsu.edu/offices/envhs/page18453.html Chemical Hygiene Plan: http://www.bgsu.edu/downloads/finance/file18401.pdf Laser Safety: http://www.bgsu.edu/offices/envhs/page107300.html Investigator’s Name (type) Investigator Protocol # Investigator’s Signature Date 14