RT Journal Article
SR Electronic
T1 The stipulations of one institutional review board: a five year review
JF Journal of Medical Ethics
JO J Med Ethics
FD BMJ Publishing Group Ltd and Institute of Medical Ethics
SP 308
OP 310
DO 10.1136/jme.2002.002105
VO 30
IS 3
A1 R A Sansone
A1 S McDonald
A1 P Hanley
A1 M Sellbom
A1 G A Gaither
YR 2004
UL http://jme.bmj.com/content/30/3/308.abstract
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 (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.