Impact of IRB Requirements on a Multicenter Survey of Prophylactic Mastectomy Outcomes

• Published in: Annals of epidemiology 2006-04, Vol.16 (4), p.275-278
• Main Authors: Greene, Sarah M., Geiger, Ann M., Harris, Emily L., Altschuler, Andrea, Nekhlyudov, Larissa, Barton, Mary B., Rolnick, Sharon J., Elmore, Joann G., Fletcher, Suzanne
• Format: Article
• Language: English
• Subjects: Breast Neoplasms - prevention & control; Clinical Protocols - standards; Cross-Sectional Studies; Epidemiologic Research Design; Ethics Committees; Ethics Committees, Research; Female; Health Care Surveys; Humans; Mastectomy; Multicenter Studies as Topic; Multicenter Study; Postal Service; Psychology; Survey Methodology; United States
• ISSN: 1047-2797; 1873-2585
• DOI: 10.1016/j.annepidem.2005.02.016

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.