D. What are the risks to you in this research study?

As part of the study you will undergo laboratory tests requiring a blood sample to be drawn (less than 1 teaspoon or about 4 milliliters), and a buccal swab to be taken for DNA collection. We may also ask for a skin sample, called a biopsy.

Taking a blood sample may cause some pain, bleeding or bruising at the site where the needle enters your body. Taking blood can also cause fainting or infection. Buccal swabs may cause minor irritation. However, many of these risks are very rare. Should they happen, they are self-limiting and don't require treatment.

If you are having skin biopsies done, the risks are slightly increased. Risks and side effects related to having a skin biopsy include pain, bleeding, scarring, and/or infection at the site of the biopsy. Every effort will be made to minimize all of these risks. Study physicians will choose the most inconspicuous area within the necessary region when performing biopsies.

Analgesics (numbing cream such as lidocaine) will be used to minimize discomfort for the local injection of anesthetic. You will also be given education on home care of the biopsy sites, follow-up time-line for suture removal (if applicable), signs and symptoms of infection, and contact information for study physician should concerns arise.

Risks related to genetic testing

Genetic data must be looked at in a large group rather than one person at a time in order to learn anything about how your disease is caused. If we learn something important from studying the group, we will write a paper about our findings. No one reading the paper will be able to tell you were part of this study.

The genetic tests and experiments done in this study are not without error and the meaning of what is learned is often unclear. Because of this, we will not give you the results of these tests or experiments or put them in your medical record. Because the research team is not studying all of your DNA available from the experiments, there may be problems in your DNA that we will not know about. We are only looking at a small part of your DNA information, but there is still a small a chance that we would learn something not related to your disease. If we think we have learned something that might be important for your health, the study doctor will talk to you. If you want to know more, the study doctor will tell you how to get more testing by non-research clinical laboratories to confirm the experimental findings.

If you have questions about risks of being in the study, please contact Dr. Siegel or her research team at (414) 955-2817.