Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent.
Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent.
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DOI：
10.1111/acem.14264
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发表时间：
2021-10
期刊：
影响因子：
--
通讯作者：
Silbergleit R
中科院分区：
文献类型：
--
作者：
Dickert NW;Metz K;Fetters MD;Haggins AN;Harney DK;Speight CD;Silbergleit R
紧急情况下研究的知情同意例外（EFIC）规定包含了社区咨询和公开披露的独特要求。这些要求解决了本研究背景下固有的伦理挑战。为完成这些活动，已经形成了多种方法，这些方法可能反映和促进不同的目标。本范围审查旨在确定文献中的共识领域和挥之不去的不确定性。使用了范围界定审查方法。通过使用Embase，HEIN Online，PubMed和Web of Science进行结构化检索，纳入并确定了与EFIC研究的社区咨询和公开披露相关的概念和实证文献。数据提取使用一个标准化的工具与领域的主要文献类别。在84份手稿中，主要领域包括概念或政策问题、社区协商过程和结果的报告以及公开披露过程和结果的报告。与社区协商相关的共识领域包括需要双向信息交换和使用多种方法。公众对个人外汇基金投资者中心登记的接受度一般为64%至85%。关于如何评估态度、优先考虑哪些“社区”以及如何确定个别项目的适当性，共识较少。公开披露的核心目标制定得不太完善;没有评估充分性的衡量标准。采用多种方法满足社区咨询和公开披露要求。在评估公开披露的充分性方面，仍然没有确定的规范，关于社区协商所需的广度和深度的辩论也挥之不去。
Exception from informed consent (EFIC) regulations for research in emergency settings contain unique requirements for community consultation and public disclosure. These requirements address ethical challenges intrinsic to this research context. Multiple approaches have evolved to accomplish these activities that may reflect and advance different aims. This scoping review was designed to identify areas of consensus and lingering uncertainty in the literature. Scoping review methodology was used. Conceptual and empirical literature related to community consultation and public disclosure for EFIC research was included and identified through a structured search using Embase, HEIN Online, PubMed, and Web of Science. Data were extracted using a standardized tool with domains for major literature categories. Among 84 manuscripts, major domains included conceptual or policy issues, reports of community consultation processes and results, and reports of public disclosure processes and results. Areas of consensus related to community consultation included the need for a two-way exchange of information and use of multiple methods. Public acceptance of personal EFIC enrollment is commonly 64% to 85%. There is less consensus regarding how to assess attitudes, what “communities” to prioritize, and how to determine adequacy for individual projects. Core goals of public disclosure are less well developed; no metrics exist for assessing adequacy. Multiple methods are used to meet community consultation and public disclosure requirements. There remain no settled norms for assessing adequacy of public disclosure, and there is lingering debate about needed breadth and depth of community consultation.
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影响因子：
4.4
作者：
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作者：
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