C. What is involved in the research study?

  1. Informed consent and permission to use or disclose your health information for research purposes will be obtained by the principal investigator, Dr. Siegel, or her research team. You will receive a copy of the consent form.
  2. You will complete forms providing family background information. You will also be interviewed about your medical background and condition. You may receive these forms on Survey Monkey so that you can complete the form and return it to us online. You can skip any questions you do not want to answer.
  3. A blood sample will be drawn from your arm, removing cells to perform a genetic test called genome-wide analysis. We may ask for a second blood sample or a buccal sample if we have problems processing the first or need a larger sample.
  4. If you have tissue removed it may be examined and preserved for genetic testing.
  5. There may be cases when we will also get a skin biopsy to grow additional cells. You may or may not be asked to give one to two 3–4 mm skin biopsies, depending on the condition of your disease and location of the hemangioma. The doctor will let you know if you will be asked for a biopsy.
    a. If biopsies are needed, the doctor will find the best place to take the skin sample. We will attempt to take the biopsy from the least noticeable area. Numbing cream such as lidocaine will be applied to the area to minimize discomfort. Next, a small of amount of local anesthetic will be injected into the area.
    b. A small tool that looks like a pen will be used to take a sample of your skin about the size of a pencil eraser. One to two small stitches will be put in to close up the area and the area will be dressed to prevent infection.
    c. Finally, the doctor will give instructions on how to change the bandage and keep the area clean in order to prevent infection and promote healing.
  6. You/your child may consent to have a photograph taken to document the area of concern, as well as use for teaching, presentations, or publications.
    a. If you are seen in clinic at CHW, the hemangioma will be photographed at the time of the clinic visit. If you are not seen in a clinic, visit at CHW, then Dr. Siegel will ask you to send her a digital image via email or mail a CD containing the images.
    b. Your identity in the photographs will be concealed by covering the eyes with a black bar. If photos with identifying features are used for publication you will be able to inspect them prior to release. Photographs will not be released to anyone else without your written permission. The photographs will be stored indefinitely.
    c. You may choose to participate in the study without permitting the release of your photos.
  7. You may be contacted by phone or email if information needed for the data base was unknown or missed at the time of the interview.

You can give these samples at Children's Wisconsin or you can give the samples at a laboratory close to your home. We will help make arrangements to have the samples shipped to us at Children's.

We expect you to be involved in this study until you have the genetic testing performed. However, your genetic material will remain in the study until all testing and analysis is completed, which will be approximately 20 years. At that time, if all of your genetic material has not already been used up, it will be destroyed.

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