确保各国具有足够的研究能力对于有效和高效地应对传染病暴发至关重要。在突发公共卫生事件期间,国际研究伦理准则中体现的伦理原则和价值观得到了广泛认可。公共卫生官员,研究人员和其他相关利益相关者还必须仔细平衡分配给即时治疗和控制活动的时间和资源,将研究作为疫情应对的一部分。在这种情况下,研究“伦理准备”是有效应对传染病暴发和其他突发卫生事件的重要基础。
2018年3月,世界卫生组织全球卫生伦理小组和非洲流行病研究组织召开了为期两天的研讨会。响应和培训,与国家道德委员会的代表,确定与道德审查准备相关的实际过程和程序。讲习班审议了可以开展工作以促进快速和健全的伦理审查的五个领域:为疫情应对准备国家伦理委员会;协议预审查;多国审查;国家伦理委员会与其他主要利益攸关方之间的协调;数据和利益分享;以及向第三国出口样品。在本文中,我们提出了研讨会的建议。特别是,与会者建议,道德委员会将为应急道德审查制定正式的国家标准作业程序;有必要澄清通用协议预审查的术语和期望,并商定具体术语;有必要探索多国应急道德协商机制,并建立国家伦理委员会和其他监督机构与公共卫生当局之间的沟通程序。此外,有人建议伦理委员会应该要求研究人员,至少,初步的数据共享和样本共享计划,概述了要从中提取数据和样本的人群的利益。这应该在适当的时候制定一个完整的计划。
希望国家伦理委员会,在世卫组织的支持下,相关合作研究财团和外部资助机构,将努力将这些建议付诸实践,支持在疫情爆发期间进行有效的研究。
Ensuring that countries have adequate research capacities is essential for an effective and efficient response to infectious disease outbreaks. The need for ethical principles and values embodied in international research ethics guidelines to be upheld during public health emergencies is widely recognized. Public health officials, researchers and other concerned stakeholders also have to carefully balance time and resources allocated to immediate treatment and control activities, with an approach that integrates research as part of the outbreak response. Under such circumstances, research \"ethics preparedness\" constitutes an important foundation for an effective response to infectious disease outbreaks and other health emergencies.
A two-day workshop was convened in March 2018 by the World Health Organisation Global Health Ethics Team and the African coaLition for Epidemic Research, Response and Training, with representatives of National Ethics Committees, to identify practical processes and procedures related to ethics review preparedness. The workshop considered five areas where work might be undertaken to facilitate rapid and sound ethics
review: preparing national ethics committees for outbreak response; pre-
review of protocols; multi-country
review; coordination between national ethics committees and other key stakeholders; data and benefit sharing; and export of samples to third countries. In this paper, we present the recommendations that resulted from the workshop. In particular, the participants recommended that Ethics Committees would develop a formal national standard operating procedure for emergency response ethical
review; that there is a need to clarify the terminology and expectations of pre-
review of generic protocols and agree upon specific terminology; that there is a need to explore mechanisms for multi-country emergency ethical consultation, and to establish procedures for communication between national ethics committees and other oversight bodies and public health authorities. In addition, it was suggested that ethics committees should request from researchers, at a minimum, a preliminary data sharing and sample sharing plan that outlines the benefit to the population from which data and samples are to be drawn. This should be followed in due time by a full plan.
It is hoped that the national ethics committees, supported by the WHO, relevant collaborative research consortia and external funding agencies, will work towards bringing these recommendations into practice, for supporting the conduct of effective research during outbreaks.