Institutional Review Board, Hospital for Special Surgery
March 20, 2019
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.
The purpose of this study is to gain new understandings of autoimmune and inflammatory diseases, including systemic lupus erythematosus, rheumatoid arthritis, scleroderma, myositis, osteoarthritis, and others. Of particular interest is our longitudinal study of patients with systemic lupus erythematosus through investigation of patients enrolled in the “Flare” cohort. Study of the biologic samples and clinical data from those patients continues to inform understanding of the immune mechanisms that underlie disease activity in lupus, and has provided the rationale for development of new therapeutic agents.
Researchers at the Hospital for Special Surgery would like to obtain samples of blood and/or urine from individuals that are affected by these diseases, along with information about the features of your disease. We are particularly interested in collecting blood samples over time, during the course of your disease. We will perform analysis of your blood or urine samples to characterize the molecules and cells of your immune system and other molecules and cells that interact with the immune system. The samples collected will also be compared to individuals who are not affected by these diseases and will be analyzed in relation to your disease activity, organ involvement and blood tests. By comparing samples from those affected and those not affected by these diseases, we can evaluate mechanisms of autoimmune diseases and determine new targets for therapeutic intervention.
Study participation is voluntary. If consented into this study, we will draw 1-5 tube(s) of blood from a vein in your arm at each of your doctor visits, for up to a total of 8 visits.
1. Must be 13 years of age or older
2. Must have a history or diagnosis of an autoimmune or inflammatory disease or be willing to serve as a healthy volunteer
3. Must be willing to donate up to 20 mL of blood (about 4 teaspoons) per visit
4. Must be willing to complete and sign an Informed Consent Form upon agreeing to be in the study
5. Must be a patient at the Hospital for Special Surgery or a healthy volunteer
6. Must be willing to answer a short questionnaire about yourself