کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
3445910 1595353 2006 4 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Impact of IRB Requirements on a Multicenter Survey of Prophylactic Mastectomy Outcomes
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی پزشکی و دندانپزشکی (عمومی)
پیش نمایش صفحه اول مقاله
Impact of IRB Requirements on a Multicenter Survey of Prophylactic Mastectomy Outcomes
چکیده انگلیسی

ObjectiveThis study assesses the variability in requirements among six institutional review boards (IRBs) and the resulting protocol variations for a multicenter mailed survey.Study Design and SettingWe 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.ResultsIRB 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.ConclusionSite-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.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Annals of Epidemiology - Volume 16, Issue 4, April 2006, Pages 275–278
نویسندگان
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