Why Public Comments Matter: The Case of the National Institutes of Health Policy on Single Institutional Review Board Review of Multicenter Studies.
Why Public Comments Matter: The Case of the National Institutes of Health Policy on Single Institutional Review Board Review of Multicenter Studies.
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为什么公众评论很重要：美国国立卫生政策研究所对多中心研究的单一机构审查委员会审查的案例。
DOI：
10.1097/acm.0000000000002206
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发表时间：
2018
期刊：
影响因子：
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通讯作者：
Meinert,CurtisL
中科院分区：
文献类型：
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作者：
Ervin,Ann-Margret;Taylor,HollyA;Ehrhardt,Stephan;Meinert,CurtisL
2014年，美国国立卫生研究院（NIH）就一项政策草案征求公众意见，该政策草案要求NIH资助的美国研究者使用单一的机构审查委员会（sIRB）对多中心研究进行伦理审查。作者进行了定向的内容分析和定性总结的意见，并讨论他们如何塑造最终policy.MethodTwo审查独立评估的政策，从审查意见的政策草案在2016年的支持。评审员进行了开放文本评审，以确定预先指定的和额外的评论主题。第二个研究人员审查了20%的意见，通过discussion.ResultsThe NIH收到167条意见：65%（108/167）支持的政策，23%（38/167）不支持，12%（21/167）不表示支持。102/167条评论（61%）建议对政策进行澄清或修改。选择sIRB的标准在32/102条评论（31%）中得到了解决。还讨论了机构审查委员会（IRB）的职责（39/102; 38%）、成本（27/102; 26%）、当地IRB的作用（14/102; 14%）和允许的政策例外（19/102; 19%）。NIH在最终政策（2016年6月）中进一步澄清或提供了选择标准，IRB责任和成本的指南。当地IRB审查和豁免指南是changed.ConclusionsIn这种情况下，公众意见是有效的，在塑造政策作为NIH修改条款或计划补充指导意见。然而，关键的知识差距仍然存在，需要经验数据。美国国立卫生研究院正在考虑建立机制，以支持建立实施sIRB的最佳实践。
PurposeIn 2014, the National Institutes of Health (NIH) requested public comments on a draft policy requiring NIH-funded, US-based investigators to use a single institutional review board (sIRB) for ethical review of multicenter studies. The authors conducted a directed content analysis and qualitative summary of the comments and discuss how they shaped the final policy.MethodTwo reviewers independently assessed support for the policy from a review of comments on the draft policy in 2016. A reviewer conducted an open text review to identify prespecified and additional comment themes. A second researcher reviewed 20% of comments; discrepancies were resolved through discussion.ResultsThe NIH received 167 comments: 65%(108/167) supportive of the policy, 23%(38/167) not supportive, and 12%(21/167) not indicating support. Clarifications or changes to the policy were suggested in 102/167 comments (61%). Criteria for selecting sIRBs were addressed in 32/102 comments (31%). Also addressed were institutional review board (IRB) responsibilities (39/102; 38%), cost (27/102; 26%), the role of local IRBs (14/102; 14%), and allowable policy exceptions (19/102; 19%). The NIH further clarified or provided guidance for selection criteria, IRB responsibilities, and cost in the final policy (June 2016). Local IRB reviews and exemptions guidance were unchanged.ConclusionsIn this case study, public comments were effective in shaping policy as the NIH modified provisions or planned supplemental guidance in response to comments. Yet critical knowledge gaps remain, and empirical data are necessary. The NIH is considering mechanisms to support the establishment of best practices for sIRB implementation.