Are Central Institutional Review Boards the Solution? The National Heart, Lung, and Blood Institute Working Group's Report on Optimizing the IRB Process
Are Central Institutional Review Boards the Solution? The National Heart, Lung, and Blood Institute Working Group's Report on Optimizing the IRB Process
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DOI：
10.1097/acm.0b013e3182720859
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发表时间：
2012-12-01
影响因子：
7.4
通讯作者：
Wagner, Todd H.
中科院分区：
文献类型：
--
作者：
Mascette, Alice M.;Bernard, Gordon R.;Wagner, Todd H.
美国国立卫生研究院的国家心肺血液研究所 (NHLBI) 于 2011 年 6 月召集了一个工作组来审查替代机构审查委员会 (IRB) 模型。该工作组的召开是为了应对政府支持的研究法规的拟议变更以及多中心临床试验的激增，在这些试验中，多个单独的审查可能效率低下。小组成员包括心脏、肺和血液研究、研究监督、生物伦理学、卫生经济学、法规和信息技术 (IT) 领域的专家。该小组讨论了替代 IRB 模型、道德问题、评估 IRB 的指标、IT 需求和经济考虑因素。参与者指出了 IRB 最佳实践和指标方面的研究差距。该小组提出了流程变更的建议，例如在资助公告中定义具体的IRB绩效要求，要求受资助的研究人员使用更有效的替代IRB模型，以及开发IT系统以促进IRB之间的信息共享和协作。尽管国家癌症研究所的中央 IRB (CIRB) 取得了成功，但工作组担心新 CIRB 的创建成本和未知的成本效率，以及将处理多个 IRB 的负担从申办者转移到研究机构的风险，因此不建议创建 NHLBI 资助的 CIRB。
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health convened a working group in June 2011 to examine alternative institutional review board (IRB) models. The working group was held in response to proposed changes in the regulations for government-supported research and the proliferation of multicenter clinical trials where multiple individual reviews may be inefficient. Group members included experts in heart, lung, and blood research, research oversight, bioethics, health economics, regulations, and information technology (IT). The group discussed alternative IRB models, ethical concerns, metrics for evaluating IRBs, IT needs, and economic considerations. Participants noted research gaps in IRB best practices and in metrics. The group arrived at recommendations for process changes, such as defining specific IRB performance requirements in funding announcements, requiring funded researchers to use more efficient alternative IRB models, and developing IT systems to facilitate information sharing and collaboration among IRBs. Despite the success of the National Cancer Institute's central IRB (CIRB), the working group, concerned about the creation costs and unknown cost-efficiency of a new CIRB, and about the risk of shifting the burden of dealing with multiple IRBs from sponsors to research institutions, did not recommend the creation of an NHLBI-funded CIRB.