Specifications include, but are not limited to: The University of Illinois at Chicago is seeking proposals to provide commercial institutional review board services on an as-needed basis to the Office of the Protection of Research Subjects.  Meets the National Institute of Health (NIH) definition of a clinical trial. “A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)�.  Is a Phase I/II /III /IV clinical trial as defined in the US FDA regulations at 21CFR 312.21.  Research is designed and research protocol is written by the sponsor.  Sponsor holds all Investigational New Drug (IND) applications /Investigational Device Exemptions (IDE)s.  Research has not previously been submitted to the UIC IRB for review.  Research is greater than minimal risk.  Research that involves adult and minor subjects.
