Institutional Review Board, Hospital for Special Surgery
July 08, 2011
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.
This is a registry involving standard of care treatment and questionnaires at each office visit. We anticipate approximately 800 patients from this site. Patients will be followed approximately twice a year as long as they continue under care at this site.
All patients must meet the designated diagnostic or classification criteria for at least one of the diseases listed below in order to be approached to be in this registry protocol.
The defined pediatric rheumatic diseases include:
Subject/legal guardian is unwilling to provide contact information for one or more individuals outside the subjectís primary residence who are likely to be in contact with the subject/parent/parent or guardian and are willing to be contacted in the event study staff cannot make contact with the subject and/or parent/guardian
Chahait Singh, BS