EXPLANATION OF RESEARCH
Title of Project: Identifying the role of molecular mimicry in affecting the exacerbations and remissions of systemic lupus erythematous through patient centered outcome research methodology
Principal Investigator: Katelyn M. Updyke, Shazia Beg, M.D., James Solomon, M.D. Ph.D.
Faculty Supervisor: James Solomon, M.D. Ph.D.
You are being invited to take part in a research study. Whether you take part is up to you.
· People with systemic lupus erythematous (SLE) suffer from progressive relapses and remissions with non-uniform responses to a variety of medical treatments. It is thought that certain exposures can contribute to severity of SLE symptoms. It is still unclear which of these exposures affect which patients, as well as whether or not these factors interact with each other or with other factors that have yet to be identified.
· Our group from Ameriderm Research and UCF will be using a highly detailed survey in which participants can update from month to month in order to track thousands of the activities of SLE patients and how it correlates with their SLE symptoms.
· The purpose of this study is to identify comparable people who react similarly to certain triggers and post what triggers hurt and help individuals within that population. Identification of these subpopulations can provide valuable information to better control their symptoms and severity of disease states.
· A username and password and account number will be assigned to you so you can continue your monthly entries. When you initially log onto your account you will be asked to answer a detailed series of questions about your SLE, current and past treatments; your past and present other medical history, exposures to possible aggravating factors, and other lifestyle issues that may affect your SLE.
· You will provide no personal identifiers beyond age, sex, and the name of the state in which you reside. If you do not reside in the US, list only your country's name.
· We ask you to revisit the survey monthly, updating your information with any changes in your SLE status, medical history, treatments, outcome assessments, etc. This will help us better understand why disease fluctuations occur and why they may be worse or better in different individuals.
· This is a lengthy survey that is completely voluntary and you can take at your own pace. You will need approximately 90 minutes to complete the initial survey, but you will have the option to log in and out as you please. The time to complete the monthly surveys may vary depending on the changes that are made to your survey responses.
You must be 18 years of age or older to take part in this research study.
Study contact for questions about the study or to report a problem: If you have questions, concerns, or complaints, contact Dr. James Solomon, Faculty Supervisor University of Central Florida, Directory of Ameriderm Research (386) 523.0768, or by e-mail firstname.lastname@example.org
IRB contact about your rights in the study or to report a complaint: Research at the University of Central Florida involving human participants is carried out under the oversight of the Institutional Review Board (UCF IRB). This research has been reviewed and approved by the IRB. For information about the rights of people who take part in research, please contact: Institutional Review Board, University of Central Florida, Office of Research & Commercialization, 12201 Research Parkway, Suite 501, Orlando, FL 32826-3246 or by telephone at (407) 823-2901.