Greene Sarah M, Geiger Ann M, Harris Emily L, Altschuler Andrea, Nekhlyudov Larissa, Barton Mary B, Rolnick Sharon J, Elmore Joann G, Fletcher Suzanne
Group Health Cooperative Center for Health Studies, Seattle, WA 98101, USA.
Ann Epidemiol. 2006 Apr;16(4):275-8. doi: 10.1016/j.annepidem.2005.02.016. Epub 2005 Jul 6.
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.
本研究评估了六个机构审查委员会（IRB）之间要求的差异，以及由此导致的多中心邮寄调查方案的差异。
我们采用横断面邮寄调查，收集六个健康维护组织中女性预防性乳房切除术长期心理社会结果的信息，所有这些组织都是癌症研究网络的一部分。在这项合作研究中，我们描述了不同机构审查委员会（IRB）审查过程对研究方案和参与情况的影响。
机构审查委员会（IRB）的审查导致了在与参与者接触前医生同意、邀请函内容和签署人以及激励类型方面的地点差异。审查过程除了初始申请外还需要进行两到八次修改，并导致了意外的延误和成本。
机构审查委员会（IRB）要求的地点差异可能会对科学严谨性产生不利影响，并延迟合作研究的实施，特别是在项目规划中未考虑到这一点时。机构审查委员会（IRB）审查是研究的一个重要方面，但对于多中心研究来说可能会带来重大挑战。
