Institutional Review Board, Hospital for Special Surgery
June 22, 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.
Chronic pain, defined as pain that persists for at least three months, is a major public health problem that is growing worse as gaps in our knowledge base continue and the population at risk grows. This project will allow the development of a collaborative research partnership among 4 academic hospital-based, interdisciplinary pain clinics (Hospital for Special Surgery, Weill Cornell NYPH, and Memorial Sloan Kettering) and the Institute for Clinical Outcomes Research (ICOR) at International Severity Information Systems, Inc. (ISIS) to develop a chronic pain registry and apply the state of the art research methodology called Practice-Based Evidence (PBE).
Inclusion criteria will be:
1. Chronic pain, defined as pain persisting for more than 3 months (i.e. two clinic visits separated by at least 3 months).
2. Receiving outpatient care at one of the 4 participating facilities.
3. Subjects will be cancer and noncancer patients with chronic pain.
4. Subjects 18 years of age and older
5. There is no upper age limit.
Subjects less then 18 years of age.
Semih Gungor, MD