General Information for Study Participants

What are the Lupus Genetics Studies?

These studies are a series of closely related long-term research projects sponsored by the National Institutes of Health and other funding agencies. Lupus patients and some of their family members participate by completing a questionnaire and donating a blood sample. The information and materials collected are used by researchers to determine the cause of lupus and to develop better treatment for patients who suffer from this serious illness. A major goal is to identify the genes that lead to the development of lupus.

Who is Eligible to Participate in the Studies?

We are looking for families with at least two members who are related by blood and have been diagnosed with lupus. We will also need some unaffected blood related family members to participate. From among those family members available, the recruiter will identify which unaffected family members will be needed in the study. We will need at least one member who is not a blood relative to also participate, i.e., the spouse or a close family friend of a participant. We are also looking for families where a lupus patient, his or her parents, and an unaffected same-sex sister or brother are available.

What Do I Have To Do To Participate?

Please call the recruiter at 1-888-655-8787 or (405) 271-7479.

She will talk with you about the family members that are affected and will determine if your family qualifies for a study. She then will obtain phone numbers, addresses, and other pertinent information for each family member that will be participating. Each participant will need to read and evaluate the Informed Consent Form for the study. The Consent Form includes the same information that is in this brochure plus information about how we conform to federal guidelines for doing research with human subjects. Participation in the study is voluntary. If a possible participant agrees to the terms of the Informed Consent Form, then he or she may sign the Form, thereby indicating his or her willingness to become a participant. Each participant will be requested to complete a Questionnaire which requires about 30 minutes to complete. About six (6) tablespoons of blood will be drawn from each adult participant. Adults have eight (8) to ten (10) quarts of blood circulating throughout their bodies. The amount removed for the study will not appreciably affect your health. (For children, a smaller amount of blood is taken, depending on their size. We following the guideline of one (1) teaspoon of blood for each ten (10) pounds of the child's weight.) We will send all blood drawing supplies and paperwork to you by Federal Express. The blood samples and paperwork are returned to us by Federal Express using the completed airbill (shipping label) included with the supplies. Of course, we have arranged to pay the Federal Express charges. You have your blood drawn at the clinic, lab, or hospital of your choice. Some of these facilities are helpful when they know that it is for a research project. Others will not be able to accommodate this request. If needed, the recruiter will assist you in making arrangements to have your blood drawn. Participants who have been diagnosed with lupus are interviewed on the telephone about their symptoms of lupus and other aspects of their medical history. The length of the phone interview varies depending on the extent of the participant's medical history. We also arrange to review what medical records there might be from the participants who have lupus. No person will be identifiable by name in any reports or publications about this study, and we go to great lengths to preserve the confidentiality of all participants.

What Are The Risks?

The risks associated with the withdrawal of blood are minimal. Occasionally, a person may experience tiredness. There have been rare instances of dizziness or fainting. A bruise may appear at the point of withdrawal and, very rarely, infection has been known to occur.

How Will I Benefit From Participating?

There are no direct benefits to participants; however, you will be reimbursed $20.00 for travel and other expenses incurred. If you have to travel more than 20 miles to have your blood drawn, you will be reimbursed an additional $10.00, for a total of $30.00. Our plan is to evaluate each person's blood for antibodies to components of normal tissue. These are tests commonly used to help diagnose lupus. This will be done free of charge. By participating, you become part of a large team of patients, family members, doctors, nurses, scientists and staff who are all helping to understand and develop more effective therapies for lupus. If each of us does his part, then together we will find the causes and cures which will help end the suffering this disease now causes for so many.

What Will Be Done With My Blood?

1. A group of tests that are important for diagnosing lupus will be performed. The results of these tests will be sent to you if you choose to receive them.

2. The DNA in your blood will be analyzed to help determine which genes may be involved in lupus and to address other scientific questions as they arise.

3. A permanent cell line will be established and this cell line may be used for other studies at a later time.

4. Some of your blood cells will be stored for use in later studies.

5. The materials and information you provide will be used to help conquer lupus and to perform other important medical research.

Who Is Doing This Project?

The study is being conducted at the Oklahoma Medical Research Foundation, a private, non-profit organization in Oklahoma City, along with many different medical research projects. Dr. John Harley is the principal investigator. Dr. Harley is also a Professor in Rheumatology at the University of Oklahoma Health Sciences Center, College of Medicine. He sees many lupus patients in the course of his duties at the medical center. There are more than a dozen other people who work full time and come students, doctors, and a statistician that works part-time.

What Else Do I Need To Know About This?

Information we gain about you from testing your blood or reviewing your medical records will not be shared with your family members. Every practical effort will be made to protect the confidentiality of all participants. Only certain staff members who work on these studies will have access to personal identifiers. The information released to other researchers will not include any personal identification such as name, social security number, phone number or address.

If you have other questions about the study, please call our recruiters toll free at:

1-888-OKLUPUS (655-8787)

or locally at

(405) 271-7479

or write to us at:

Lupus Genetics Studies

825 NE 13th

Oklahoma City, OK 73104