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- W2150642012 abstract "This study assesses the variability in requirements among six institutional review boards (IRBs) and the resulting protocol variations for a multicenter mailed survey. We utilized a cross-sectional mailed survey to gather information on long-term psychosocial outcomes of prophylactic mastectomy among women at six health maintenance organizations, all of which are part of the Cancer Research Network. In the context of this collaborative study, we characterized the impact of the different sites' IRB review processes on the study protocol and participation. IRB review resulted in site differences in physician consent prior to participant contact, invitation letter content and signatories, and incentive type. The review process required two to eight modifications beyond the initial application and resulted in unanticipated delays and costs. Site-to-site variability in IRB requirements may adversely impact scientific rigor and delay implementation of collaborative studies, especially when not considered in project planning. IRB review is an essential aspect of research but one that can present substantial challenges for multicenter studies." @default.
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- W2150642012 date "2006-04-01" @default.
- W2150642012 modified "2023-10-02" @default.
- W2150642012 title "Impact of IRB Requirements on a Multicenter Survey of Prophylactic Mastectomy Outcomes" @default.
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- W2150642012 doi "https://doi.org/10.1016/j.annepidem.2005.02.016" @default.
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