The stipulations of one institutional review board: A five year review

Abstract

Objectives: This study was desiged to explore the prevalence and type of stipulations (such as clorifications 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 minute of the IRB meetings. Setting: Community hospital. Participantss: 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 stipulation 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 submissions of research proposals may reduce the frequency of stipulations required of investigations.