How are the patients rights and safety protected?
IRB: Before a clinical trial begins, the physician conducting the study must receive permission from an Institutional Review Board (“IRB”). An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. In addition to examining the protocol prior to a trial’s commencement, an IRB will periodically monitor a trial to ensure that risks to the patients are minimized.
