...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Annals of epidemiology >Impact of IRB requirements on a multicenter survey of prophylactic mastectomy outcomes.
【24h】

Impact of IRB requirements on a multicenter survey of prophylactic mastectomy outcomes.

机译：IRB要求对预防性乳房切除术结局的多中心调查的影响。

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

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.
机译：目的：本研究评估了六个机构审查委员会（IRB）之间的要求差异以及由此产生的多中心邮寄调查的方案差异。研究设计和设置：我们采用横断面邮寄调查收集了六个健康维护组织中妇女进行预防性乳房切除术的长期社会心理结果的信息，所有这些都是癌症研究网络的一部分。在此协作研究的背景下，我们描述了不同站点的IRB审核过程对研究方案和参与的影响。结果：IRB审查导致参与者接触之前，医生同意书，邀请函内容和签字人以及激励类型方面的站点差异。审核过程需要在初次应用后进行两到八次修改，并导致意外的延迟和成本。结论：IRB要求的站点间差异可能会对科学严谨性产生不利影响，并延迟协作研究的实施，尤其是在项目计划中未考虑的情况下。 IRB审查是研究的重要方面，但它可能对多中心研究提出重大挑战。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号