3D medical animation still of Ebola virus

维基媒体有限公司mmons; Manu Sharma, www.scientificanimations.com

Zika virus, Ebola virus, and avian flu outbreaks are among the more recent and well-known international public health emergencies. It is critical to quickly control such outbreaks to minimize spreading, but often there is no standard treatment or vaccine. Therefore researchers investigating new drugs or treatments must work against the clock to discover effective treatments, without compromising ethical standards.

So how can we ease the process of ethics approval during public health emergencies? In anarticlerecently published inBMC医学伦理，研究人员Emilie Alirolet al.describe their experience with世界卫生组织（WHO）ethics review during the recent Ebola virus outbreak in West Africa, providing recommendations to accelerate study approval in future health emergencies.

埃博拉病毒爆发（2013-2016）

The 2013-2016 Ebola Outbreak was the largest outbreak of Ebola virus in history, and also the most deadly. With approximately 11,300 reported deaths, this outbreak killed more people than all previous outbreaks combined. At the start of the epidemic, Ebola virus research was limited to laboratory studies and data from previous outbreaks. There was no established vaccine available, and potential vaccines were still in early development. This proved especially concerning given the high mortality rate (40-90% dependent on country) and the large scale in which the disease was spreading.

鉴于爆发的紧迫性，如果不妥协道德标准，则可以接受使用未注册的医疗干预措施。它还允许简化的审查过程，希望更快地识别潜在治疗方法。

未来公共卫生紧急情况的建议

在爆发期间，WHO-ERC审查了24种新方案和22项修订协议，包括观察和介入研究。在Emilie Alirol的文章中等，提出了许多方法来帮助加速研究批准过程，这些方法适用于任何未来的疾病暴发，而不仅仅是埃博拉病毒。

他们发现，不正确或不完整的信息是快速伦理批准的最常见的障碍。例如，缺少有关数据共享，不适当的参与者信息文档或诸如样本量之类的细节不一致的信息。尽管时间压力，建议对文档进行彻底审查，以防止不必要的延迟，因为这些问题是可以避免的。

Closer collaboration between local and international researchers may also prove effective. Studies during the Ebola outbreak were often led by international researchers, as resources were limited in locally affected areas. Local researchers have beneficial knowledge of the local culture which can be used to encourage study participation and provide advice on appropriate study plans, ultimately fast-tracking the study process.

模板协议和联合委员会

提议的更具体的系统之一包括制定数据和样本所有权和使用的模板协议。许多研究没有提供足够的这些信息，从而延迟了批准。由于谈判这些协议可能很耗时，因此作者建议制定模板协议，可以从国际咨询和讨论中起草。

他们还建议组建一个联合道德审查委员会，因为许多审判都需要获得多个道德委员会的批准。联合委员会将包括与爆发有关的国家或机构的委员会成员。联合委员会不再等待多个委员会的批准，而是会缩短批准时间，同时还提供跨审判数据的价值。

孕妇和儿童的参与

可以说，实施最困难的建议是将孕妇和儿童纳入临床试验。在以前的埃博拉病毒爆发中，孕妇的死亡率约为90％，死亡率最高的是4岁以下的儿童。鉴于这些群体的死亡率很高，因此它们最有可能从健康干预中受益。

These rates encouraged the WHO-ERC to request protocol amendments that include children and pregnant women in studies. Despite the potential benefits, pregnant women and children were not included in any of the studies, likely due to ethical and liability concerns.

因为通常将他们排除在试验之外，所以儿童和孕妇通常会根据其他群体的数据接受治疗。为了在健康紧急情况下改善其临床护理，本文的作者推动了他们在未来爆发期间的包容性。

Preparing for future outbreaks

The issue of timeliness is one of the most challenging aspects of conducting clinical research during public health emergencies. The experience of Emilie Alirolet al.在埃博拉病毒爆发期间，在此类紧急情况下，研究人员面临的许多问题。他们为我们提供有用的建议，以加快道德批准过程，应考虑这些建议以准备将来的爆发。