Consent Part 2 Patient Identification Label

OWNER CONSENT FOR PULMONARY FIBROSIS RESEARCH STUDY – Part 2

“Computed Tomography (CT) Features of Pulmonary Fibrosis in Dogs” Principal Investigator: Drs. Ned Patterson DVM, PhD, Board Certified Small Animal Medicine Veterinary Clinical Sciences Department College of Veterinary Medicine University of Minnesota 612-625-5799 Institutional Animal Care and Use Committee: 612-626-2126 Purpose of Study: In that past 15 years, a form of Pulmonary (lung) Fibrosis (scarring) has been recognized in some dogs, almost exclusively in West Highland white terriers (WHWT). The prognosis is guarded with many dogs dying from progressive lung failure within 12–18 months. Currently, the underlying cause and genetics of Pulmonary Fibrosis in dogs is poorly understood with only one published report investigating the possible causes. A genetic predisposition is strongly suspected because of the preponderance of WHWT reported to have confirmed IPF. The diagnosis in dogs is usually made based on clinical signs, arterial blood gas analysis, and chest radiographs, and the diagnosis is greatly improved by using High Resolution Computed Tomography (HR -CT). Currently there is no known specific treatment and therapy is at best to relieve the symptoms. The purpose of this study is to perform HRCT in a portion of the dogs with low blood oxygen, and evidence of lung scarring from part 1 of the study to more fully diagnose possible pulmonary fibrosis. Dogs with a full diagnostic work up will be more valuable for the DNA studies described in part 1. The HRCT will also help ensure they are not affected with a different or additional lung disease that might have an alternative treatment options.

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Procedures: A rapid high resolution CT scan will be performed on your dog that typically takes about 5 minutes. We will place an IV catheter in your dog and gently restrain them during the scan. If they are unable to remain still during the scan, with your permission, we will administer a short acting (5-15 minute) anesthetic, by intravenous injection IV injection, a breathing tube and gas anesthetic with assisted ventilation. With anesthesia blood oxygen saturation, heart electrical activity, breathing and other parameters will be carefully monitored continuously with oversight by a board certified veterinary radiologist. Your dog will need to be fasted for at least 12 hours prior to the high resolution CT. Expected Duration of Participation: Your dog will need to be dropped of at the U of MN Veterinary Medical Center by 7 am on the day of the high resolution CT and not fed for the 12 hours prior. Depending on the time of the CT, they will likely to be able to go home sometime from 2pm to 8pm the same day. Potential Benefits:  By allowing us to evaluate your dog, you will contribute to discoveries that may help diagnose and hopefully treat pulmonary fibrosis in dogs. We will also be more confident of the diagnosis of pulmonary fibrosis and see if there are any signs of other respiratory disease that might call for a different treatment protocol. Possible Discomforts/Risks:  Without sedation or anesthesia, there are very minimal risks, the main one being x-ray exposure. A CT scan is similar to a number of standard x-rays all at once, and the amount of radiation exposure is minimal if they are not frequently done in the same patient.  With anesthesia, there is a small risk of heart, breathing or other complications. If a complication does occur, many times we can treat it for relatively minimal costs, rarely there would be a major costly complication or an anesthetic death.  To be sure you are fully aware of any risks, we will have you sign this consent for part 2 of the study, and also our standard hospital consent for a CT and possible sedation or anesthesia. We will be sure to answer all of your questions regarding this before we have you sign the two consent forms. Financial Obligations: The CT scan and sedation or anesthesia will be at no cost to you. Our grant is unable to cover other significant medical or surgical costs associated with your dog’s care. If an anesthetic complication does occur, we have a budget for up to $400 of additional costs to treat it, but any costs beyond the additional $400 would need to be paid you. In this unlikely event of an anesthetic complication, we would call you immediately to discuss all details and options, and therefore need a phone number that you will always be available at on the day of the CT. Termination of Participation: Your participation in this study is entirely voluntary. You may withdraw your dog from the study at any time point with no penalty and without any effect on your relationship 2 of 3

with the University of Minnesota or your veterinarian. Your dog’s health is important to us. Therefore, if your dog develops a serious illness during the study or if the study evaluations create undue stress for your dog, we may ask that you forego your dog’s participation in the study. All results will be confidential. Information about your dog may be used in scientific presentations and/or publication. However, no personal or identifying information about you or your pet will be released.

Patient Identification Label

I have read and understand all the preceding information describing part 2 of this study. All of my questions have been answered to my satisfaction. I am the owner of the animal that will participate in this study or the owner’s designated representative and hereby voluntarily consent to participation the study. Signed:

Date:

Investigator:

Date:

If you have any other questions or concerns regarding this study, please contact Dr. Patterson at University of Minnesota, College of Veterinary Medicine, 612–625–5799 or 612-626-8387.

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