Public Comments on the Proposed Common Rule Mandate for Single-IRB Review of Multisite Research.
Public Comments on the Proposed Common Rule Mandate for Single-IRB Review of Multisite Research.
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DOI：
10.1002/eahr.500002
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发表时间：
2019-01-01
影响因子：
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通讯作者：
Ervin, Ann-Margret
中科院分区：
文献类型：
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作者：
Taylor, Holly A;Ehrhardt, Stephan;Ervin, Ann-Margret
我们审查了公众对卫生与公众服务部（DHHS）最初和修订后的提案的回应，该提案要求对联邦资助的多地点研究进行单一irb审查，以了解谁回应了拟议的授权，并确定他们说了什么，以及该机构如何在其修订后的提案中处理公众意见。我们的分析表明，对单一内部审查委员会的支持是有限的。反对拟议的任务规定的最常见的论点来自于那些担心具体地点机构审查委员会（IRB）对多地点研究方案的审查，以解决与当地情况有关的问题的人。也有人表示关切，单一内部审查委员会办法将用另一个可能效率低下的制度（涉及谈判和管理多个机构间协议）取代一个效率低下的制度（例如需要对一项研究进行多次审查）。需要对DHHS的最终规则和国家卫生研究院的单独规则的实施情况进行实证研究，以确定单一irb模式是否达到了既定目标。
We reviewed the public comments submitted in response to the Department of Health and Human Services' (DHHS's) original and revised proposal for mandated single-IRB review of federally funded multisite research to see who responded to the proposed mandate and to determine what they said and how the agency addressed the public comments in its revised proposal. Our analysis indicates that support for the single-IRB mandate was limited. The most common argument against the proposed mandate came from those concerned with the loss of site-specific institutional review board (IRB) review of the protocol for a multisite study to address issues relevant to local context. Concerns were also raised that the single-IRB approach would replace one inefficient system (that entails, for example, multiple reviews of a single study) with another potentially inefficient system (involving the negotiation and management of multiple interinstitutional agreements). Empirical research about the implementation of DHHS's final rule-and the separate rule of the National Institutes of Health-mandating single-IRB review is needed to determine whether the single-IRB model achieves the stated goals.