Institutional Review Board, Hospital for Special Surgery
July 06, 2005
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.
Rheumatologists and scientists at HSS are studying proteins (called "immune complexes") in patients with lupus. They are interested in looking at these immune complexes to try to understand how and why they cause or worsen lupus. Participating involves donating 6 tubes of blood. No extra trips to HSS are needed. We currently have over 100 patients enrolled.
Participants must have an unequivocal diagnosis of SLE (satisfying 4 or more American College of Rheumatology (ACR) criteria for SLE), APS, or both conditions. Have active disease.