Consent Part 1 Patient Identification Label

OWNER CONSENT FOR PULMONARY FIBROSIS RESEARCH STUDY – Part 1

“Clinical Features and Genetic Basis of Pulmonary Fibrosis in Dogs” Principal Investigator: Dr. 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 (PF) 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 PF. 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 but does not affect the progression of the disease. The purposes of this study are 1) to obtain blood DNA samples, 2) obtain blood gas samples from dogs affected with pulmonary fibrosis and dogs over 8 years of age that are not affected, and 3) to get chest x-rays of dogs that have low blood oxygen and might be affected with pulmonary fibrosis. We will use the DNA samples to sequence the whole genome (all the DNA sequence) of some of the dogs, and later possibly to get DNA marker data for all the dogs enrolled. We will compare the DNA of affected dogs versus unaffected dogs to see if we can detect gene mutations that predispose dogs to develop pulmonary fibrosis. If gene mutations are found, and verified, they could be used as a test to diagnosis pulmonary fibrosis and also as a test to help breeding decisions to help decrease the number of WHWT with pulmonary fibrosis. In addition, knowledge of the genes involved hopefully will later lead to specific treatments being developed.

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Procedures: Two blood samples (equal to approximately ½ tablespoon each) will be collected for analysis. The blood will be obtained in a standard fashion from an artery and a vein on the leg or foot or neck. For dogs with low blood oxygen based on the blood analysis, chest radiographs (also called X-rays) will be taken to see if there are signs of scarring (fibrosis) in the lungs. Expected Duration of Participation: Blood collection and blood oxygen analysis usually takes about 20-40 minutes. Chest x-rays usually take about 30-45 minutes additional time. Potential Benefits:  Sample collection is brief and is associated with no or minimal distress to your dog.  You will not be responsible for the costs of any procedures performed for the purpose of the study.  Your dog will receive a free physical examination, and blood testing that evaluates blood oxygen and other lung values.  If your dog has low blood oxygen, there will be free screening to look at their lungs via x-rays.  By allowing us to evaluate your dog, you will contribute to discoveries that may help diagnose and also hopefully treat pulmonary fibrosis in dogs. These results may also eventually help with the diagnosis and treatment of a very similar condition in people. Possible Discomforts/Risks:  Drawing blood takes approximately 30 seconds. Minimal, short-term discomfort is associated with inserting the needle under the skin and into a vein or artery. The amount of blood removed is small and will not affect the health of your dog. We may shave a small portion of the fur on the leg, foot or neck to better visualize the vein or artery. There could be some mild bleeding from the needle site. We will place a temporary bandage over the site for at least 15 minutes.  For chest x-rays, your dog will be gently held on his/her side and placed in soft bedding on his/her side and back. Financial Obligations: The blood sample collection, and possible chest X-rays, will be performed at no cost to you. Our grant is unable to cover any other medical or surgical costs associated with your dog’s care unrelated to the sample collection and analysis. However, we are available to assist you and your primary care veterinarian, if appropriate, with recommendations related to your dog’s medical care. 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 with the University of Minnesota or your veterinarian. Your dog’s health is important to 2 of 3

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 1 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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