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首页> 外文期刊>Nutrition in clinical practice: official publication of the American Society for Parenteral and Enteral Nutrition >Understanding Institutional Review Boards: Practical Guidance to the IRB Review Process.
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Understanding Institutional Review Boards: Practical Guidance to the IRB Review Process.

机译：了解机构审查委员会：IRB审查程序的实用指南。

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摘要

The purpose of this paper is to provide practical guidance to assist investigators in the preparation of materials and obtaining approval for research projects that require oversight by an institutional review board (IRB). The central requirements for IRB approval and core considerations of IRBs are described. Specific suggestions for investigators regarding how to prepare their IRB applications to anticipate and address potential IRB concerns and questions are proposed. When researchers are familiar with these criteria and how they may be interpreted by an IRB, they can avoid deferrals or lengthy requests for protocol modifications or clarifications. General tips regarding the preparation of IRB submission materials that may allow for a smoother IRB review process are also discussed. A brief list of additional resources for investigators is appended.
机译：本文的目的是提供实际指导，以协助研究人员准备材料并获得需要机构审查委员会（IRB）监督的研究项目的批准。描述了IRB批准的主要要求和IRB的核心考虑。对于研究人员如何准备其IRB申请以预期和解决潜在的IRB问题和疑问，提出了具体建议。当研究人员熟悉这些标准以及IRB可能如何解释它们时，他们可以避免延期或对协议修改或澄清的冗长要求。还讨论了有关准备IRB提交材料的一般技巧，这些材料可能会使IRB审查过程更为顺畅。附加了用于调查人员的其他资源的简短列表。

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