Animal Care/Use Program AMENDMENT FORM ORC Use Only: Protocol #: __ __ - __ __ __ Amendment Approval: Form completion instructions: To populate a box, 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. Protocol Title: Click here to enter text. Principal Investigator: Name: Click here to enter text. Department: Click here to enter text. This application requests amendment of the animal use protocol for the above project by changes in (check all area/s which apply): ☐ Animal subjects: Check applicable option(s) below: ☐ Species ☐ Number Complete 1 – Change in Species or Animal Numbers ☐ Activity location: Check applicable option(s) below: ☐ Housing ☐ Non-surgical procedure ☐ Survival surgery ☐ Non-survival surgery Complete 2 – Change in Location of Animal Activity ☐ Non-surgical procedure or treatment Complete 3 – Change in Non-surgical procedure AND 5 - Purpose and scientific benefit of procedures to be added. ☐ Surgery or intra-operative procedure: Check applicable option(s) below: ☐ Non-survival ☐ Survival ☐ Multiple survival Complete 4- Change in Surgical Procedure AND 5 - Purpose and scientific benefit of procedures to be added ☐ Post-surgical or post-procedure care and monitoring or humane endpoints Complete 6 - Change in animal care and monitoring or humane endpoints ☐ Use of hazardous agents: Check applicable option(s) below: ☐ Biological ☐ Chemical ☐ Radiological ☐ Laser Complete 7 - Change in use of hazardous agents administered to animals ☐ Method of euthanasia: Complete 8 ☐ Personnel: Check applicable option(s) below. NOTE: Relevant training is mandatory for all professional & technical personnel involved with animal research protocol, including students. ☐ Addition or deletion of individuals with a significant role in the project such as the administration of anesthesia, performing surgery, giving injections, etc. ☐ Change in project roles for existing personnel Complete 9 - Change in personnel or personnel roles. ☐ Other significant change in activity: Complete 10 - Other change in animal use activity. 1. Change in Species or Animal Numbers Add ☐ ☐ Delete Species Click here to enter ☐ text. Click here to enter ☐ text. ☐ ☐ ☐ ☐ Click here to enter text. Click here to enter text. Number approved Click here to enter text. Number to be added 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. Justification for change in species: Click here to enter text. Justification for additional animals, including experimental groups and the basis for group sizes: Click here to enter text. 2. Change in location for approved animal activity Add Delete ☐ ☐ ☐ ☐ Building Click here to enter text. Click here to enter text. Room Click here to enter text. Click here to enter text. Activity Click here to enter text. Species involved Click here to enter text. Click here to enter text. Click here to enter text. Reason for the change in location, and identification of location, activity, or species not specified above: Click here to enter text. 3. Change in non-surgical procedure. Check applicable option(s) below. NOTE: AV review is required for additions that have potential for more than slight or momentary pain or distress. ☐ Add procedures described in detail below: Click here to enter text. ☐ Delete previously approved procedures specified below: Click here to enter text. For additions, complete the following checkboxes and item #5 below: Pain or distress category will be: ☐ No pain or distress ☐ Momentary or slight pain or distress ☐ Pain or distress relieved by anesthesia, analgesia, or sedation ☐ Pain or distress that will not be relieved by drugs Post procedure monitoring will be: ☐ As described in approved protocol ☐ As described in # 6 below Humane endpoints will be: ☐ As described in approved protocol IACUC Amendment Form – August 2015 Page 2 of 7 ☐ As described in # 6 below 4. Change in surgical procedure. ☐ Add non-survival surgery procedures: Add description in box below: Click here to enter text. ☐ Add survival surgery procedures described in detail below: Click here to enter text. ☐ Delete previously approved survival or non-survival surgery procedures specified below: Click here to enter text. Justification for repeated survival surgery on individual animals, if multiple survival surgery is added: Click here to enter text. For additions, complete the following areas below and #5 below: Pain or distress categories for added surgery: Check applicable option(s) below. ☐ Pain or distress relieved by anesthesia, analgesia, or sedation ☐ Pain or distress that will not be relieved by drugs Post procedure monitoring will be: ☐ As described in approved protocol ☐ As described in # 6 below Humane endpoints will be: ☐ As described in approved protocol ☐ As described in # 6 below 5. Purpose and scientific benefit of procedures to be added. Specify the relationship of added procedures to the purpose of the study as described in the approved protocol: Click here to enter text. State how the added procedures will contribute to the scientific benefit of the approved protocol: Click here to enter text. 6. Change in animal care and monitoring or humane endpoints. ☐ Add post-procedure and/or post-surgical care and monitoring procedures described in detail below: Click here to enter text. ☐ Delete previously approved care and monitoring procedures specified below, including reason for deletion: Click here to enter text. For additions, summarize monitoring indices and humane endpoints below: Monitoring during recovery from anesthesia (until sternal recumbancy): Index ☐ ☐ ☐ ☐ ☐ Body temperature Heart rate Blood pressure Respirations Other (specify): Click here to enter text. IACUC Amendment Form – August 2015 Page 3 of 7 Observation frequency 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. Monitoring to detect post-surgical or post-procedure pain or distress: ☐ ☐ ☐ ☐ ☐ ☐ Index Body weight Food consumption Activity Appearance Behavior Other: (specify) Observation frequency 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. Duration of monitoring 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. Humane endpoints used to remove animals from study to avoid chronic pain or distress: ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Not eating > 48 hours Weight loss > 20% of normal weight Mutilation of operative site Depression > 72 hours Non-weight bearing > 72 hours Infection not resolved with antimicrobial therapy Moderate to severe clinical signs of pain and distress unalleviated by appropriate analgesics Other (specify): Click here to enter text. 7. Change in use of hazardous agents administered to animals. Add hazardous agent use as described in detail below: Click here to enter text. Delete use of hazardous agents specified below: Click here to enter text. For additions, complete the following: Nature of hazardous agents: Select all that apply: ☐ Biological (pathogens, human cells, tissues or fluids, tumor cells, non-replicating viruses, ☐ ☐ ☐ ☐ recombinant DNA) Toxicological Laser Radiological (isotopes or ionizing radiation) Carcinogenic Agent identification: Agent Name / Description Click here to enter text. Type of Agent ☐ Biological Hazard Dose / Concentration Click here to enter text. ☐ Chemical Hazard ☐ Radiation Hazard ☐ Other Specify: IACUC Amendment Form – August 2015 Page 4 of 7 Route Click here to enter text. Frequency of Administration Click here to enter text. Anticipated Duration of Effect Method of Waste Disposal Click here to enter text. Click here to enter text. Agent Name / Description Click here to enter text. Type of Agent ☐ Biological Hazard Dose / Concentration Click here to enter text. ☐ Chemical Hazard Route Click here to enter text. Frequency of Administration Click here to enter text. Anticipated Duration of Effect Method of Waste Disposal Click here to enter text. Click here to enter text. ☐ Radiation Hazard ☐ Other Specify: 8. Change in method of euthanasia. Describe method: Click here to enter text. Scientific justification for use of the above method: Click here to enter text. 9. Change in personnel or personnel roles. For addition of personnel, please fill in rows as indicated. To add rows… Personnel to be Added Techniques FOR IACUC OFFICE ONLY Select all that apply for this project/protocol. Select all that apply for this project/protocol. 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 ☐ Temporary Personnel ☐ Other Specify: Click here to enter text. IACUC Amendment Form – August 2015 Page 5 of 7 (Continued) ☐ 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. CITI Training Completed? Vivarium Orientation Completed? Enrolled in Occ Health Program? ☐ YES ☐ YES ☐ YES Date:_________ Date:_______ Date:_____ ☐ NO ☐ NO ☐ NO For removal of personnel, provide full name and 800 # below: First Name Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Last Name Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. 800 # Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. For change in project role of personnel, complete the below table: Change in animal handling role for existing personnel: Name (First and Last) New or additional animal handling role in project Click here to enter text. ☐ Principal Investigator ☐ Co-Investigator ☐ Animal Handler ☐ Animal Orderer ☐ Official Contact ☐ Emergency Contact ☐ Surgeon ☐ Temporary Personnel ☐ Other Specify: Click here to enter text. ☐ Principal Investigator Click here to enter text. ☐ Co-Investigator ☐ Animal Handler ☐ Animal Orderer ☐ Official Contact ☐ Emergency Contact ☐ Surgeon ☐ Temporary Personnel ☐ Other Specify: Click here to enter text. IACUC Amendment Form – August 2015 Page 6 of 7 New or additional technique(s) NOTE: The AV reserves the right to request training and demonstration of proficiency of personnel prior to use of new or added techniques on live animals. ☐ 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 ☐ ☐ ☐ ☐ 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 ☐ Ear notch/ear tag ☐ Weighing / measuring ☐ Cardiac puncture ☐ Cervical dislocation w/ anesthesia ☐ CO2 euthanasia ☐ Decapitation w/ anesthesia ☐ Exsanguination ☐ Retro-orbital injection ☐ Saphenous bleed ☐ Tall clip bleed ☐ Other Specify: Click here to enter text. 10. Other change in animal use activity. Add activity described in detail below: Click here to enter text. Delete activity specified below: Click here to enter text. PI Assurance Statement: I assure that the information contained on this form is accurate to the best of my knowledge. I affirm that I will continue to uphold my responsibilities as Principal Investigator as detailed in the PI Assurance Statement I signed upon the initial approval of this referenced protocol for the balance of the time the IACUC has allotted for this study. I and all lab personnel listed on this protocol will continue to conform to all applicable federal regulations and institutional policies regarding the care and use of animals on this study. _____________________________________________ PI Signature ________________ Date Chair Approval and Signature – For Office Use Only: ______________________________________ ___________________ Dr. Yvette Huet – Chair Date IACUC Amendment Form – August 2015 Page 7 of 7