Institutional Review Board, Hospital for Special Surgery
May 11, 2010
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.
Prospective Research Study, the Registry. Includes patients with any condition for which they seek care of the physicians in the Foot and Ankle Service. The purpose of the Registry is to evaluate short and long-term outcomes after surgical and conservative treatment of foot and ankle problems in all categories of patients. This will help members of the department evaluate subjective outcomes in patients they have treated. The Registry will involve the collection and entry of standard of care data into the secured and password protected database, that would normally be collected by all 8 members of the Foot and Ankle Service. Duration of Follow up every 1,3,5, and 10 years.