Institutional Review Board, Hospital for Special Surgery
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.
Thedore T. Miller, MD, FACR
Gregory R. Saboeiro, MD
Lorene Janowski, Occupational Therapist
· Diagnosis of hemiplegic Cerebral Palsy with flexor tendon spasticity
· Patient of the principal investigator
· Age 2 years and older
· Able to understand the informed consent and sign consent/assent for themselves
· Prior surgeries on affected arm
· Patients who are unable to understand the informed consent and sign the consent/assent for themselves