Institutional Review Board, Hospital for Special Surgery
October 26, 2009
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Number of Patients we expect to enroll: 1200. One follow up visit is required. If you or your child decides to participate, we will draw 2 tubes (approximately 3 teaspoons) of blood from a vein in your arm. We will also ask you or your child some general questions along with some information about your/his/her medical history. The blood you or your child donates will be stored in a repository and used by scientists at HSS and other institutions for research studies on Systemic Lupus Erythematosus and/or Anti-Phospholipid Syndrome. All information identifying you or your child as a participant in this study will be kept confidential. All records and blood samples will be coded and all personal identifiers will be removed to ensure confidentiality. Your participation in this study should take approximately 15 minutes.
In order to be eligible for the Autoimmune Disease Registry and Repository, you must have an unequivocal diagnosis of SLE and/or Anti-Phospholipid Syndrome; be over the age of 10 years; and not be pregnant.