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The stipulations of one institutional review board: a five year review
R A Sansone1, S McDonald, P Hanley
1Departments of Psychiatry and Internal Medicine, Wright State University School of Medicine, Dayton, Ohio, USA. randy.sansone@kmcnetwork.org
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.
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