Impact of IRB Requirements on a Multicenter Survey of Prophylactic Mastectomy Outcomes SARAH M. GREENE, MPH, ANN M. GEIGER, PHD, MPH, EMILY L. HARRIS, PHD, MPH, ANDREA ALTSCHULER, PHD, LARISSA NEKHLYUDOV, MD, MPH, MARY B. BARTON, MD, MSC, SHARON J. ROLNICK, PHD, JOANN G. ELMORE, MD, MPH, AND SUZANNE FLETCHER, MD, MSC OBJECTIVE: This 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 SETTING: 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. RESULTS: 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. CONCLUSION: 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. Ann Epidemiol 2006;16:275–278. Ó 2006 Elsevier Inc. All rights reserved. KEY WORDS: Ethics Committees, Multicenter Study, Survey Methodology. INTRODUCTION Among the fundamental tenets of scientific research are consistency and standardization. Scientific rigor is achieved through a study design that is coherent and replicable, treating every research participant as similarly as possible, while ensuring protection of participants from undue risks. In multicenter studies, participant protection requires that each site obtain institutional review board (IRB) approval. Variation in interpretation and application of regulations can result in site-specific requirements that may compromise consistency. In addition, reconciling multiple iterative reviews can adversely affect study timelines and budgets. Others have characterized the impact of IRB variability in the context of a clinical trial (1) and a genetic epidemiology study (2). We describe the impact of different IRB requirements on a six-site mailed survey of psychosocial outcomes after prophylactic mastectomy. MATERIALS AND METHODS This study was conducted within the Cancer Research Network, a National Cancer Institute-funded consortium of 11 research centers based in nonprofit health plans that studies cancer control interventions throughout the natural history of cancer. Six plans participated: Group Health Cooperative, Washington; Harvard Pilgrim Health Care, Massachusetts; HealthPartners, Minnesota; and three re- gions of Kaiser Permanente: Northwest (Oregon), and Northern and Southern California. Each site received IRB approval for this study. Participants were recruited by mail using an invitation letter accompanied by a survey, return envelope, and $5 incentive. Nonrespondents received a second mailing without the incentive and a telephone reminder call with an optional third survey mailing. The seven-page survey From the Group Health Cooperative Center for Health Studies, Seattle, WA (S.M.G.); Kaiser Permanente Southern California, Department of Research and Evaluation, Pasadena, CA (A.M.G.); Kaiser Permanente Northwest, Center for Health Research, Portland, OR (E.L.H.) Kaiser Permanente Northern California, Division of Research, Oakland, CA (A.A.); Harvard Pilgrim Health Care, Department of Ambulatory Care and Prevention, Boston, MA (L.N., M.B.B., S.F.); Health Partners Research Foundation, Minneapolis, MN (S.J.R.); and University of Washington, Department of General Internal Medicine, Seattle, WA (J.G.E.). Address correspondence to: Sarah M. Greene, MPH, Group Health Cooperative Center for Health Studies, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101. Tel.: (206) 287-2989; fax: (206) 287-2871. E-mail: greene.sm@ghc.org. This project was funded by a grant from the National Cancer Institute, grant number 1R01CA90323. Received December 2, 2004; accepted February 11, 2005. Ó 2006 Elsevier Inc. All rights reserved. 1047-2797/06/$–see front matter 360 Park Avenue South, New York, NY 10010 doi:10.1016/j.annepidem.2005.02.016