New Lupus Study - Do you want to take part?

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Note: forwarded message attached.From: "Toxic Discovery" <toxicdiscovery@...><Undisclosed-Recipient:;>Subject: New Lupus Study - Do you want to take part?Date: Thu, 30 Nov 2006 16:03:46 -0600 Informed Consent Begins With Informed Individuals Toxic Discovery"Informed Consent Begins With Informed Individuals" TOXIC DISCOVERY1906 Grant LaneColumbia, MO. 65203 toxicdiscovery@...www.toxicdiscovery.com tel: fax: (573) 817-2090(573) 445-4700 Lupus Study If you are interested - please contact: Laurie E (612) 625 1107 Study Coordinator Genetics of SLE Research>University of Minnesota>Division of Rheumatic and Autoimmune Diseases Department of MedicineMayo Mail Code 334 420 Delaware Street S.E Minneapolis, MN 55455 kylex009@... Consent for Participation in a Research

Study THE GENETICS OF SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) You are invited to participate in a research study of lupus (SLE). You were selected because

either: · we would like you to serve as a control OR · you or your family may have someone with SLE or an SLE-like condition. We ask that you read this form before agreeing to participate in the study. Background Information This study is being conducted by Dr. Behrens in the Department of Medicine at the University of Minnesota. The purpose of this study is to discover something about how a person’s genetic background or genes may make them more likely to develop SLE. We will be studying blood samples from both people diagnosed with SLE and unaffected family members as well as healthy controls. Participation in this study may involve: (1) Answering questions regarding your health either by telephone or by questionnaire. (2) Contacting some of your family members to then have them contact our study coordinator if they are interested in the study. (3) Giving permission for us to contact your

doctors to verify your diagnosis. (4) Donating a blood sample. The total amount of blood drawn will be about 4-5 tablespoons. The samples can be drawn at a clinic near your home. (5) Your blood sample will be processed to isolate DNA and RNA (your genetic material). The DNA and RNA will be used to try and identify the “genetic factors” or genes that a person inherits that predispose to SLE. Blood samples may also be processed for serum (the liquid part of blood), and for the cells within blood. Risks of Being in the Study The risk involved in giving a blood sample is the very small amount of pain involved as the needle enters through the skin into the vein, as well as the possibility that a small bruise will form at the place where the blood is taken. Very occasionally an individual can faint after having had blood taken. You will not be compensated for any pain or suffering, but we estimate that these will be minimal to non-existent. In the unlikely event that this blood draw results in an injury, treatment will be available, including first aid, emergency treatment and follow up care as needed at your local clinic. Payment for any such treatment must be provided by you or your insurance company. Confidentiality The records of this study will be kept private. In any sort of report that we might publish, we will not include any information that will make it possible to identify you. Your records will be reviewed only by the doctors and approved staff coordinating the study. To ensure your privacy, your information and blood will be coded numerically as they arrive in our

clinic. Your information will not be part of your personal medical record, but will be a part of the research records at the University of Minnesota for an unlimited number of years. Blood Sample Information: The DNA and RNA (genetic material), serum (the liquid part of the blood), or cells from the blood will be kept for an unlimited number of years in the laboratory of and under the ownership of W Behrens, MD. All identifying information will be removed from the samples so that your confidentiality will be maintained. These samples will be utilized as needed to help find the causes of autoimmune or inflammatory disorders and other diseases where blood cells may provide clues about what causes the disease to develop. Voluntary Nature of the Study This is a voluntary study. If you decide not to participate, this will in no way be held against you. Your decision whether or not to participate will not affect your current or future relations with the clinic or institution through which you heard about this study or with the University of Minnesota. If

you decide to participate you are free to withdraw at any time without affecting those relationships. If you are contacted in the future about participation in this study or invited to participate in other studies, you do have the right to decline further involvement. New Information If during the course of this study there are significant new findings discovered which might influence your willingness to continue, the

researchers will inform you of these developments. We thank you for your help and participation in this study. If you have any questions contact us at toll free 1 -800-515-8787 or Dr. Behrens at (612) 625-1107. The Genetics of SLE Family Study, University of Minnesota Mayo Mail Code 334, 420 Delaware Street SE, Minneapolis MN 55455 If you have any questions or concerns regarding the study and would like to talk to someone other than the researchers, contact the following by phone, in writing or in person: Fairview Research Helpline toll free 866-508-6961 or 612-672-7692 Fairview University Medical Center – Riverside Campus #815 Professional Building, 2450 Riverside

Avenue, Minneapolis, MN 55454. STATEMENT OF CONSENT I have read the above information. I have asked any questions I wish to ask and have received satisfactory answers. I consent to participate in the “Genetics of SLE Study.” Signature: _____________________________ Date: ___________ Print Name: _____________________________ *************************************** Printed Name of Investigator: W. Behrens, MD Signature of Investigator: _____________________

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