The stipulations of one institutional review board: a five year review.

OBJECTIVES This study was designed to explore the prevalence and types of stipulations (such as clarifications or changes) required of investigators by the institutional review board (IRB) of one institution over a five year period. DESIGN Stipulations to research proposals (n = 124) were documented from the minutes of the IRB meetings. SETTING Community hospital. PARTICIPANTS IRB submissions. MAIN MEASUREMENTS Number and type of IRB stipulations. RESULTS Nineteen research submissions (15.3%) were approved without any stipulations. For the remainder, the majority of stipulations related to consent forms (74.2%). CONCLUSIONS Consent forms appear to be at highest risk for IRB stipulations. Being aware of high risk areas before submission of research proposals may reduce the frequency of stipulations required of investigators.