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研究与全球卫生突发事件:论最佳实践的重要作用。

Research and Global Health Emergencies: On the Essential Role of Best Practice.

作者信息

Sethi Nayha

机构信息

Liminal Spaces, Mason Institute, University of Edinburgh.

出版信息

Public Health Ethics. 2018 Jul 24;11(3):237-250. doi: 10.1093/phe/phy014. eCollection 2018 Nov.

Abstract

This article addresses an important, overlooked regulatory challenge during global health emergencies (GHEs). It provides novel insights into how, and why, best practice can support decision makers in interpreting and implementing key guidance on conducting research during GHEs. The ability to conduct research before, during and after such events is crucial. The recent West-African Ebola outbreaks and the Zika virus have highlighted considerable room for improvement in meeting the imperative to research and rapidly develop effective therapies. A means of effectively capturing these experiences and folding them into future decision-making is lacking; the need for effective practical translational measures remains. The challenge for the research community lies in extracting meaningful action-guiding content from pre-existing guidelines-which draw upon practical examples of guidelines 'in action'-that assist in determining how to act in a particular (future) situation. Insights are provided into the role of best practice as a means to do so; such examples can provide invaluable support to decision makers in interpreting high-level guidance; overarching guidelines retain their necessary level of generality and flexibility, whilst corresponding best practice examples-which incorporate important lessons learned-illustrate how such guidelines can be interpreted at a practical level.

摘要

本文探讨了全球卫生紧急事件(GHEs)期间一个重要却被忽视的监管挑战。它就最佳实践如何以及为何能够支持决策者解读和实施关于在全球卫生紧急事件期间开展研究的关键指南,提供了新颖的见解。在此类事件之前、期间及之后开展研究的能力至关重要。近期西非埃博拉疫情爆发以及寨卡病毒事件凸显出在满足开展研究并迅速研发有效疗法这一迫切需求方面仍有很大的改进空间。目前缺乏一种有效收集这些经验并将其纳入未来决策的方法;对有效的实际转化措施的需求依然存在。研究界面临的挑战在于从现有指南中提炼出有意义的行动指导内容,这些指南借鉴了“实际应用”的指南实例,有助于确定在特定(未来)情况下如何行动。本文深入探讨了最佳实践作为实现这一目标的手段所发挥的作用;此类实例可为决策者解读高层指南提供宝贵支持;总体指南保持其必要的一般性和灵活性,而包含重要经验教训的相应最佳实践实例则说明了此类指南在实际层面应如何解读。

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