PT - JOURNAL ARTICLE AU - R A Sansone AU - S McDonald AU - P Hanley AU - M Sellbom AU - G A Gaither TI - The stipulations of one institutional review board: a five year review AID - 10.1136/jme.2002.002105 DP - 2004 Jun 01 TA - Journal of Medical Ethics PG - 308--310 VI - 30 IP - 3 4099 - http://jme.bmj.com/content/30/3/308.short 4100 - http://jme.bmj.com/content/30/3/308.full SO - J Med Ethics2004 Jun 01; 30 AB - 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 (nā€Š=ā€Š124) 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.