This booklet, prepared by the Human Subjects Office/IRB, provides guidance to University of Iowa investigators who may be uncertain if their study meets the definitions of human subjects research stated in the federal regulations (45CFR46.102). The HSO/IRB recognizes that the definition may not always provide a straightforward answer. 

Do I need IRB Review?  Is This Human Subjects Research? A Guide for Investigators offers investigators an explanation of the definitions as well as examples of studies that do or do not qualify as human subjects research. For further information, please refer to the Resources section in the back of this booklet.  Credit is given to the University of Southern California Office for the Protection of Research Subjects (OPRS) for the concept and as a primary source of information.  Credit is also given to the IRB Chairs and HSO staff for their contributions to this booklet.