Objectives: This study was designed to explore the prevalence and types of stipulations required of investigators by the institutional review board of one institution over a five year period.Design: Stipulations to research proposals 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 were approved without any stipulations. For the remainder, the majority of stipulations related to consent forms .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. (shrink)

Background:Medical research involving human subjects must be evaluated by a research ethics committee before a study is initiated. However, knowledge of REC decision processes, particularly in relation to evaluating the risk–benefit balance in various study types, appears scant.Methods:The study protocols and records of a Finnish university hospital REC were surveyed for a time span of 5 years. All study procedures in each study plan were examined, and the studies were divided into clinical drug trials, clinical trials with medical devices, studies (...) with other invasive interventions, studies with non-invasive physical procedures, and non-physical procedures only.Results:In clinical drug trials, the REC posed queries more frequently about the risk–benefit ratio and less frequently about study methods and participant-related issues in comparison with other study types. Relative to other studies, those with non-physical procedures were subject to more frequent queries related to reliability of the study... (shrink)