ORC Use Only: Protocol #: Approval: IACUC Application Core Experimental Protocol Form Instructions: Please complete all sections of this core protocol application and all applicable appendices and submit with Principal Investigator signature to the Office of Research Compliance (ORC). All new and continuing applications will undergo Attending Veterinarian consultation and review by ORC prior to IACUC review. Please allow 4-6 weeks from time of submission for IACUC review. Form completion instructions: To populate a box simply click once on the box to show the “X.” To uncheck box, click on it once more to remove “X.” For narrative responses, click on the prompt text (“Click here to enter text”) and begin typing. GENERAL INFORMATION: Is this a new or continuation application? ☐ New application ☐ Continuation application Previous protocol #: Click here to enter text. (e.g., 10-001) PROTOCOL TITLE: Click here to enter text. PRINCIPAL INVESTIGATOR: Name: Click here to enter text. 800 #: Click here to enter text. Department: Click here to enter text. Campus Address (Building and room #): Click here to enter text. Email: Click here to enter text. Campus Phone: 7 - Click here to enter text. Emergency phone: Click here to enter text. CO-INVESTIGATOR: Name: Click here to enter text. 800 #: Click here to enter text. Department: Click here to enter text. Campus Address (Building and room #): Click here to enter text. Email: Click here to enter text. Campus Phone: 7 - Click here to enter text. Emergency phone: Click here to enter text. ☐ FUNDED? For all funding sources listed below, submit a copy of the Research and Design Methods and Vertebrate Animal Section(s) of your proposal, scope of work, or contractual agreement with this application for grant/protocol congruency review. ☐ N/A Not Funded NOTE: If using internal funds (i.e., University or departmental), complete only the “source” and “status” areas below. SPONSOR #1: Name: Click here to enter text. Status of funding: ☐ Proposal submitted ☐ Just-in-Time notification ☐ Funds awarded/existing funding ☐ Pending ☐ Other Specify Click here to enter text. Source of funding: ☐ Federal ☐ State ☐ University ☐ Private/Foundation ☐ Other Specify Click here to enter text. Funding Period: Click here to enter text. to Click here to enter text. NORM proposal #: Click here to enter text. (e.g., 14-0500) SPONSOR #2: Name: Click here to enter text. Status of funding: ☐ Proposal submitted ☐ Just-in-Time notification ☐ Funds awarded/existing funding ☐ Pending ☐ Other Specify Click here to enter text. Source of funding: ☐ Federal ☐ State ☐ University ☐ Private/Foundation ☐ Other Specify Click here to enter text. Funding Period: Click here to enter text. to Click here to enter text. NORM proposal #: Click here to enter text. (e.g., 14-0500) Should animals be found sick or dead, please provide an emergency contact name, phone number and email address: Emergency Contact: Click here to enter text. Phone number: Click here to enter text. Email address: Click here to enter text. Core Experimental Protocol Form Page 1 of 11 SECTION I: PERSONNEL 1. Provide the following information for all personnel who will be conducting animal activities on this project. To add a row, in the “Layout” menu in Word, select “Insert Below” and copy and paste contents of previous row into new one. TIP: Do not use first row to copy. Personnel Techniques Select all that apply for this project/protocol. Name: _____________________ FOR IACUC OFFICE ONLY FOR IACUC OFFICE ONLY FOR IACUC OFFICE ONLY CITI Training Completed? Vivarium Orientation Completed? Enrolled in Occ Health Program? (Last Name, First Name, Middle Initial) 800 #: _____________________ Proposed Role(s) on Project (Select all that apply) ☐ Principal Investigator ☐ Co-Investigator ☐ Animal Handler ☐ Animal Orderer ☐ Official Contact ☐ Emergency Contact ☐ Surgeon ☐ Temporary Personnel ☐ Other Specify: Click here to enter text. Name: _____________________ (Last Name, First Name, Middle Initial) 800 #: _____________________ Proposed Role(s) on Project (Select all that apply) ☐ Principal Investigator ☐ Co-Investigator ☐ Animal Handler ☐ Animal Orderer ☐ Official Contact ☐ Emergency Contact ☐ Surgeon ☐ PI NOT DOING ANIMAL WORK ☐ CONSULTING ONLY – no animal handling ☐ Handling & restraint ☐ Administration of injectable anesthetics & analgesics ☐ Administration of inhaled anesthetics & analgesics ☐ Breeding husbandry ☐ Ear notch/ear tag ☐ Weighing / measuring ☐ Cardiac puncture ☐ Cervical dislocation w/ anesthesia ☐ CO2 euthanasia ☐ Decapitation w/ anesthesia ☐ Exsanguination ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ PI NOT DOING ANIMAL WORK ☐ CONSULTING ONLY – no animal handling ☐ Handling & restraint ☐ Administration of injectable anesthetics & analgesics ☐ Administration of inhaled anesthetics & analgesics ☐ Breeding husbandry ☐ Ear notch/ear tag ☐ Weighing / measuring ☐ Cardiac puncture ☐ Cervical dislocation w/ anesthesia ☐ CO2 euthanasia ☐ Decapitation w/ anesthesia ☐ Exsanguination ☐ Aseptic technique ☐ Incision site prep ☐ Instrument prep ☐ Suture placement /removal ☐ Intradermal injection ☐ Intramuscular injection ☐ Intraperitoneal injection ☐ Intravenous injection ☐ Oral gavage ☐ Retro-orbital bleed ☐ Retro-orbital injection ☐ Saphenous bleed ☐ Tall clip bleed ☐ Other Specify: Click here to enter text. Aseptic technique Incision site prep Instrument prep Suture placement /removal Intradermal injection Intramuscular injection Intraperitoneal injection Intravenous injection Oral gavage Retro-orbital bleed Retro-orbital injection Saphenous bleed Tall clip bleed Other Specify: Click here to enter text. ☐ YES ☐ YES ☐ YES Date: _________ Date: _______ Date: _____ ☐ NO ☐ NO ☐ NO ☐ YES ☐ YES ☐ YES Date: _________ Date: _______ Date: _____ ☐ NO ☐ NO ☐ NO ☐ Temporary Personnel ☐ Other Specify: Click here to enter text. Core Experimental Protocol Form Page 2 of 11 SECTION II: OVERVIEW OF THIS STUDY 2. Purpose: Briefly describe the overall purpose of this animal use study. This should typically be less than 75 words and be easily understood by nonscientists (e.g., ‘We propose to test the effectiveness of a new class of antiinflammatory drugs against arthritis in mice.’). Click here to enter text. 3. Importance Of and/or Scientific Benefit: Describe in non-scientific terms the importance of and/or the potential scientific benefit of the proposed study with respect to human or animal health, the advancement of knowledge, or the good of society. Please do not copy/paste from your Vertebrate Animal Section of your NIH grant or any other funding application. (250 words or less) Click here to enter text. 4. Justification/Rationale for Using Vertebrate Animals: Provide a brief justification for using live vertebrate animals rather than alternative means of achieving the research goal(s) (e.g., cannot be substituted or modeled in simpler systems or nonliving models; supported in literature/preliminary data; anatomy or physiology is uniquely suited to the study; lowest species on the phylogenetic scale that is suitable for the proposed study, etc.). Click here to enter text. SECTION III: IDENTIFICATION FOR SPECIES USE Provide the following information: Species Strain Sex / Age and/or Weight Range Source (e.g., vendor name, another institution, etc.) Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. SECTION IV: EXPERIMENTAL DESIGN AND PROCEDURES Provide a detailed narrative description of the experimental procedures and manipulations to be used in this project. Additionally, include a flow chart or bulleted list that depicts the sequence of all animal procedures or manipulations (i.e., step-by-step) to be performed on this protocol and that shows the experimental course for an animal from its entry into the experiment to the endpoint of the study. Click here to enter text. SECTION V: ANIMAL NUMBERS JUSTIFICATION The number of animals requested for this protocol is based on the following: (Check all that apply. For guidance, refer to the Sample Size and Statistical Analysis webpage.) ☐ A statistical estimate of the number required to achieve statistical significance. Provide the criteria and detailed results of a power analysis to determine the total number of animals you will require: Click here to enter text. Core Experimental Protocol Form Page 3 of 11 ☐ The estimated minimum number necessary to achieve the goals of the study in the absence of a statistical estimate. Is this a pilot study? If so, provide justification Click here to enter text. Provide justification based on previously published or preliminary data (include reference(s)). Click here to enter text. ☐ The number necessary to obtain sufficient tissue or other material for testing or analysis. Provide explanation with details for procedures Click here to enter text. ☐ The number required to provide sufficient technical training or practice for the number of trainees expected Provide explanation with details for procedures Click here to enter text. ☐ The expected or established mortality associated with this procedure Provide previously published or preliminary data or provide explanation Click here to enter text. ☐ Other Explain (details required): Click here to enter text. SECTION VI: ANIMAL NUMBER CALCULATIONS BY PAIN/DISTRESS CATEGORY; ALTERNATIVES TO PAIN/DISTRESS LITERATURE SEARCH; AND JUSTIFICATION FOR CATEGORY E STUDIES 1. Animal Number Calculations by Pain /Distress Level: Provide the estimated total number of animals requested for a three (3)-year approval period. Include numbers of animals to be listed in each appropriate USDA pain/distress category using the HIGHEST pain/distress category for proposed use. Refer to the Pain, Discomfort, or Distress Classifications webpage for details regarding the classification of procedures by category. NOTE: For continuation protocols, if there are animals remaining on the expiring protocol, please include the number of animals (on the expiring protocol) to be transferred to this application in the number of animals requested for this new application. Animals will be transferred to the new application upon IACUC approval. Pain / Distress Category Category B Category C (only momentary or slight pain & distress) Category D (use of analgesics/anesthetics to minimize pain & distress) Category E (unrelieved pain & distress) Year 1 Year 2 Year 3 Total 3 years Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Total 2. For Protocols Involving Pain/Distress Categories C, D or E: Search for Alternatives to Pain/Distress: Per federal regulations, investigators must provide a written narrative description of the methods and sources they consulted to determine the availability of alternatives (reduction, refinement, replacement) to potentially painful and distressful procedures. This can be satisfied through a literature search. Core Experimental Protocol Form Page 4 of 11 NOTE: There are many resources available to guide investigators in completing an alternatives literature search. Please refer to the Tips and Links website for links to a variety of university and national resources. You may also contact Dr. Melanie Sorrell, Health Sciences Librarian at Atkins Library for assistance in conducting a literature search for your study. She can be reached at (704) 687-8410 or via email at melanie.sorrell@uncc.edu. Please allow a few business weeks ahead of your expected need for Dr. Sorrell to complete your request. a. Which databases were searched? Please search at least 2 databases. Select all that apply: ☐ PubMed ☐ AGRICOLA ☐ AWIC ☐ BIOSYS ☐ Embase ☐ Paschal ☐ INSPEC ☐ Other List: Click here to enter text. b. Inclusive years searched (i.e. 1970 – 2012): Click here to enter text. c. Keywords used in searches: Click here to enter text. d. Description of search strategy and results: Please list or show how keywords were entered (i.e. show search strings) and briefly describe the results (i.e. how many “hits” for each keyword search string). Also provide a brief explanation as to why any resultant publications ARE / ARE NOT pertinent to your experimental design or objectives). Click here to enter text. 3. Does the proposed activity duplicate any previous work? ☐ YES If YES, please justify: ☐ NO Click here to enter text. 4. Justification: Category E ☐ N/A If you have indicated above in Section VI, Question #1 “Animal Numbers Calculations” that you are proposing procedures involving Category E (i.e., unrelieved animal pain/distress), provide scientific justification for the need to withhold pain relieving agents: Click here to enter text. SECTION VII: LOCATION OF RESEARCH Animals will be housed and used (select one): ☐ In the Vivarium only ☐ Animals will be primarily housed in the Vivarium but will be temporarily removed to: Building: Click here to enter text. Room number(s): Click here to enter text. Length of time: Click here to enter text. hours (NOTE: When animals are kept outside the Vivarium for 12 hours or more—whether for research purposes (lab, surgical suite or testing area) or for medical reasons (veterinary or surgical treatment), PHS Policy requires these “satellite” facilities to have all of the required housing parameters for the species involved as stipulated in the Guide. If proposing the use of a location as satellite housing, please contact the Office of Research Compliance at uncc-iacuc@uncc.edu or at (704) 687-1872 for the appropriate form to complete). ☐ Animals will not be housed or used on campus for this study (select for field studies, collaborative research where animals will not be housed or undergo procedures at UNC Charlotte, etc.) Core Experimental Protocol Form Page 5 of 11 ☐ Other Specify: Click here to enter text. SECTION VIII: ANIMAL IDENTIFICATION, HUSBANDRY AND MONITORING 1. Will any markings be used to identify animals? ☐ YES ☐ NO If YES, please indicate method of animal identification: ☐ ☐ ☐ ☐ ☐ ☐ ☐ Ear tagging Ear notching / ear punch Tattooing Non-toxic marker or pen Microchip Identification via tank/cage cards Other Specify: Click here to enter text. 2. Will species-specific standard enclosures (cages; tanks for aquatic animals) be used? ☐ YES ☐ NO If NO, please indicate special housing conditions: ☐ Ventilated rack system ☐ Sterile housing for immunocompromised animals ☐ Metabolic cages ☐ Single housing of animals (NOTE: Single housing of social animals is considered a deviation from the Guide and should be noted in Appendix A: Requests for Exceptions/Deviations from the Guide or IACUC policy.) ☐ Quarantined in separate room due to introduction of hazardous agents (i.e. pathogens or radioisotopes) into animals (NOTE: Please complete Appendix D – Use of Hazardous Agents to detail hazardous agent use in animals.) ☐ Other Specify: Click here to enter text. 3. Who will be primarily responsible for animal monitoring (including overnights, weekends and holidays)? (NOTE: Arrangements should be made with the Attending Veterinarian for care of animals and development of a monitoring plan PRIOR to acquisition of animals.) ☐ Research personnel only ☐ Vivarium staff and research personnel 4. Please specify how animals will be monitored both post-procedurally and throughout the study. What complications could arise and how will monitoring address these complications? Click here to enter text. 5. Will special handling of sick or dead animals be required? ☐ YES ☐ NO If YES, please specify and provide justification: Click here to enter text. 6. Are special diets, additives to food/water and/or antibiotics administered? ☐ YES ☐ NO NOTE: Food/water restriction or reduction is considered a deviation from standard husbandry guidelines in the Guide. Please provide a brief description below and complete/submit the following Appendix with this application: Appendix A: Requests for Exceptions/Deviations from the Guide or IACUC policy. Core Experimental Protocol Form Page 6 of 11 If YES, provide a brief description here: Click here to enter text. SECTION IX: USE OF ANALGESICS / ANESTHETICS 1. In the table below, provide drug, dose, route, frequency of administration and anticipated duration of therapeutic effect. Also, include ALL medications such as pre- and post-anesthetics, antibiotics, paralytics, etc. (If applicable, describe surgery in Appendix C: Survival and/or Non-Survival Surgery.) Please consult with the Attending Veterinarian when planning use of these agents. Note on drop down lists: Choose only one item per row. To unselect an option simply click on “Choose an item.” Complete other cell entry in the table by typing in information. Drug Name Frequency of Administration (indicate pre- or post-procedure if applicable) Anticipated Duration of Effect (in minutes, hours or days) Dose Route Choose an item. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Choose an item. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Choose an item. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Choose an item. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. 2. Describe monitoring procedures to ensure adequacy and safety of anesthesia or tranquilization: Click here to enter text. 3. Describe monitoring procedures for recovery from anesthesia or tranquilization: Click here to enter text. SECTION X: USE OF EXPERIMENTAL DRUGS OR COMPOUNDS ☐ N/A The Guide and the USDA Animal Welfare Act Regulations require the use of pharmaceutical-grade substances as part of experimental and/or clinical treatment of animals. However, they also note that as a part of research, it may be necessary to include the use of non-pharmaceutical grade substances as long as such use is based on scientific necessity. Please provide scientific justification for the use of experimental/non-pharmaceutical grade compounds in animals: Click here to enter text. Please refer to the IACUC Policy Use of Non-Pharmaceutical Grade Compounds and Expired Materials in Animals for IACUC-reviewed-and-approved guidance. 1. In the table below, list all experimental and/or non-pharmaceutical grade substances to be used in animals including substance name, route, volume, dose, and frequency of administration. NOTE: For every substance listed, provide the product information sheet or Safety Data Sheet (i.e., “SDS” formerly known as “MSDS”) along with your application for IACUC review. Substance Route Volume Dose (provide unit/kg) Frequency of Administration Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Core Experimental Protocol Form Page 7 of 11 Substance Route Volume Dose (provide unit/kg) Frequency of Administration Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. 2. Are there any known adverse effects from use of the listed substances at the route/dosage/frequency proposed? ☐ YES ☐ NO If YES, explain the effects anticipated and provide a brief summary of your plan to monitor and address potential side effects. Provide publication references where applicable in your response. Click here to enter text. ☐ N/A SECTION XI: TISSUE / FLUID COLLECTION 1. In the table below, list all tissue / fluid to be collected from live animals (pre-euthanasia or as a method of euthanasia, i.e. cardiac puncture and exsanguination). Provide tissue/fluid being collected, collection site, method(s), amount collected, and frequency of collection. Please refer to the Rodent Blood Collection SOP. Amount Collected Frequency of Collection Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Tissue / Fluid Method SECTION XII: ENDPOINTS (STUDY AND HUMANE) 1. STUDY ENDPOINTS - State how animal health, including pain and distress, will be assessed and specify the plan of action in case of animal illness or injury. Indicate any specific situations in which you wish to be notified prior to initiating treatment by the AV or Vivarium staff. State the criteria (for example, tumor size, percentage body weight gain or loss, inability to eat or drink, behavioral abnormalities, clinical symptoms, signs of toxicity) for terminating procedures and/or for euthanasia if your experiments involve tumors, biologics, infectious agents, radiation or toxic chemicals. Provide scientific justification if animals will not be euthanized when moribund. It is not necessary to repeat methods for monitoring and treatment following experimental procedures, which should be discussed above in Section VIII – Animal Identification, Husbandry and Monitoring. Click here to enter text. 2. HUMANE ENDPOINTS - Which humane endpoints will be used? (select all that apply): ☐ Loss of weight exceeding 20% of normal body weight ☐ Inappetance ☐ Prolonged diarrhea for 12 hours ☐ Hunched posture ☐ Non-weight bearing ☐ Porphyrin staining around eyes ☐ Ungroomed / unkempt – ruffled fur ☐ Loss of body temperature / hypothermia (evidenced by continuous shivering longer than 8-10 hours) ☐ Unsteady gait ☐ Decreased body condition score – refer to the Rodent Body Condition Score Guidelines for more information ☐ Depression for over 72 hours Core Experimental Protocol Form Page 8 of 11 ☐ Dehydration ☐ Vocalizations / respiratory difficulty ☐ Discharge from eyes, nose, perianal areas ☐ Other Specify: Click here to enter text. SECTION XIII: EUTHANASIA AND ANIMAL DISPOSITION 1. Please select all options below which best apply to your anticipated need for euthanasia as part of your proposed experimental design: ☐ Animals will be euthanized as part of the experimental protocol ☐ Euthanasia may be performed to prevent animal distress ☐ The nature of the activity/ies do not call for euthanasia (i.e. studies using animal’s natural life span, educational/observational studies, wildlife studies, etc.) 2. Provide details on the type of euthanasia to be used. Methods should be in accordance with the American Veterinary Medical Association’s (AVMA’s) Guidelines for the Euthanasia of Animals. For studies involving rodents please refer to the Rodent Euthanasia Guidelines for acceptable methods in consultation with the AV. Note on drop down lists: Choose only one item per row. To unselect an option simply click on “Choose an item.” Complete other cell entry in the table by typing in information. Method of Euthanasia Species Dose and Route of Administration (for Use of Anesthetics) Method to Ensure Death If “Other” specify method below. Click here to enter text. Choose an item. Click here to enter text. Choose an item. Click here to enter text. Choose an item. Click here to enter text. Choose an item. Click here to enter text. Choose an item. Click here to enter text. Choose an item. 3. For use of cervical dislocation or decapitation without anesthesia, indicate which method will be used and provide scientific justification for your selection: ☐ Cervical dislocation with no anesthesia Scientific justification: Click here to enter text. ☐ Decapitation with no anesthesia Scientific justification: Click here to enter text. 4. Final Disposition of Live Animals: If animals are intended to live after study objectives have been reached, please indicate their disposition: ☐ Transfer to another protocol List protocol #: Click here to enter text. ☐ Transfer to Vivarium for use ☐ Transfer to another institution – Please address all bulleted items below. Name of institution: Click here to enter text. Name of person to be in receipt of animals: Click here to enter text. Contact Information (phone/email address) of person to be in receipt of animals: Click here to enter text. Shipping Vendor to be used to transport animals (consult with the Attending Veterinarian to discuss shipping vendors, shipping costs and other logistics at least 2-3 weeks prior to planned export): Click here to enter text. Core Experimental Protocol Form Page 9 of 11 Please describe the considerations to be taken in preparing animals for export (i.e. health status, shipping logistics, permitting if applicable, how animals will be confirmed to be in good health upon arrival at final destination, etc.). Please also confirm that you will consult with the Attending Veterinarian / Director of Laboratory Animal Resources (DLAR) within 2-3 weeks in advance of shipment. Click here to enter text. Material Transfer Agreement (MTA) in place? ☐ YES ☐ NO If NO, contact the Technology Transfer Office at (704) 687-8012 to discuss whether an MTA is needed at least 4 weeks prior to transfer. ☐ Other Please specify: Click here to enter text. 5. Disposition of Carcasses – Select one option below: ☐ Placed in Vivarium freezer for disposal ☐ Placed in special container/bag and disposed of according to special handling operating procedures. ☐ Carcasses should be considered contaminated (i.e. biohazardous, radioactive, etc.). Provide directions for handling: Click here to enter text. ☐ Other Specify: Click here to enter text. OTHER SPECIAL CONSIDERATIONS: If this project will involve any of the following, please indicate by checking the corresponding box. Then complete the appropriate appendix/appendices and submit along with this core application form. ☐ Requests for Exceptions / Deviations to the Guide or IACUC policy (e.g., Dietary Manipulations / Food and/or Water Restriction; Single Housing, etc. – Please complete Appendix A ☐ Confidential or Proprietary Information – Please complete Appendix B ☐ Surgery (Survival and Non-Survival) – Please complete Appendix C ☐ Use of Hazardous Agents – Please complete Appendix D ☐ Tumor Studies – Please complete Appendix E Core Experimental Protocol Form Page 10 of 11 PRINCIPAL INVESTIGATOR ASSURANCES / SIGNATURE PAGE PROTOCOL TITLE: Click here to enter text. PRINCIPAL INVESTIGATOR: Name: Click here to enter text. BY MY SIGNATURE BELOW, I CERTIFY THAT I AGREE TO THE FOLLOWING STATEMENTS: I. I certify that I am familiar with and assure compliance in this protocol with the legal standards of animal care and use established under the Federal and State laws and the policies on animal welfare of the National Institutes of Health and UNC Charlotte; II. I assume responsibility for ensuring that all personnel working with animals on this project are familiar with and are trained in relevant animal procedures and that they will comply with established laws and policies regarding animal care and use; III. I certify that all individuals working with animals on this project will: a. b. IV. Complete online training using the CITI system as required by the IACUC; Enroll in the Occupational Health program by completing a Health History Form and submitting it to the Occupational Physician for medical clearance and submitting annual health updates; c. Complete initial Vivarium Orientation with the Attending Veterinarian, Director of Laboratory Animal Resources (DLAR), or their designees (if Vivarium access is required for their work); and d. Attend once per academic year an informational seminar and provide an annual health update as conditions for continuous good standing in the animal care/ use program; and e. Follow all applicable regulations and guidelines of the Vivarium as well as IACUC-approved policies, guidelines, and/or Standard Operating Procedures (SOPs). I certify the following: the research proposed herein is not necessarily duplicative of previously reported research; appropriate nonanimal alternatives for this research do not exist; no alternatives to the potentially painful/distressful procedures conducted in this project exist. I have indicated methods used to make these determinations in the appropriate section of this animal care/use application; V. I will secure IACUC approval before changing procedures or personnel associated with this study (including adding or removing personnel); VI. I assure that I and personnel under my direct supervision will use the animals acquired for the activity described herein solely for said purpose. I also certify that if live animals are shared with other PIs or are used in any procedure other than those described in this application, I will provide the details in the form of a written amendment to the original application prior to their use; VII. I acknowledge that veterinary care will be administered to moribund animals or animals experiencing more than momentary or slight pain and distress. Vivarium staff or the Attending Veterinarian will attempt to contact me regarding the care and treatment of a moribund animal, but will institute treatment or euthanasia, as needed, if I cannot be reached quickly; VIII. I assure that I will notify the IACUC and the Attending Veterinarian regarding any unexpected study results that adversely impact the animals, including any unanticipated pain or distress, morbidity or mortality. IX. I agree if at any time any member of the research team or their immediate family members have financial interest in, receive personal compensation from, or hold a position in an industry sponsoring this study or otherwise have a personal conflict of interest, I will complete or update my conflict of interest records in the “Activities, Interests, and Relationships” (AIR) online system and will notify anyone on my research team to do the same if warranted. X. I assure the IACUC and UNC Charlotte that the general procedures involving animals described in my grant proposal, scope of work, or contract has been described in this application and such documents have been submitted for IACUC grant/protocol congruency review; XI. I assure that I have read the AVMA Guidelines for Euthanasia of Animals and understand how it applies to the animals I will be using for research or testing purposes per this application; and XII. If I use any biological, chemical, and/or radiological hazards in animals I will contact the Office of Research Compliance for information on how to proceed. ___________________________________________ PI Signature Click here to enter text. Date: NOTE: Consultation with the Director, Laboratory Animal Resources (DLAR) regarding space allocation is recommended prior to submission of an application. IACUC approval of an application does not assure Vivarium space availability. Also, please contact the Vivarium for a pre-study strategy meeting prior to ordering animals to discuss availability of housing. NOTE: Cell lines that have been passaged in animals or maintained using animal serum may contain murine viruses that can alter the outcome of the study and may cause an outbreak of disease among other mice. ATCC does not screen cell lines for murine pathogens. Cell lines that have been passaged in animals or grown in media containing rodent serum should be tested for murine pathogens prior to use in animals. Please contact the Vivarium for more information on testing of your cell lines. Core Experimental Protocol Form Page 11 of 11