PDF(Pubmed)
Abstract：
Conducting research during disease outbreaks can be ethically challenging as evidenced in the 2014-2016 Ebola outbreak in West Africa and COVID-19 pandemic. Yet, there has been little empirical research conducted for understanding the views and perspectives of different stakeholders regarding ethical issues in conducting research during disease outbreaks. This preliminary study was conducted to empirically explore African public health research stakeholders\' views about research ethics issues during infectious disease outbreaks in Africa. We conducted an online survey of 330 participants attending the International Conference on Re-emerging and Emerging Infectious Disease (ICREID) meeting that took place from 13-15 March 2019 in Addis Ababa, Ethiopia to elicit their views on various research ethics complexities experienced in the 2014 Ebola outbreak. Study results revealed some divergent views on several ethical themes including: ethics of using unregistered interventions in outbreaks; acceptable study design; ethics review processes; risks-benefit assessment; exclusion of pregnant women and children; and biological sample and data sharing. Majority (76.3%) of respondents felt that in the absence of available standard treatments or prevention modalities, the use of investigational interventions can be ethically justifiable if there is a strong scientific rationale and favorable risk-benefit ratio. Regarding conventional placebo-controlled trials during outbreaks with high case fatality rates, respondents that considered this unethical were more than three times those that felt such design were ethically justifiable. We were somewhat surprised that a majority (almost 60%) of respondents were satisfied with the exclusion of pregnant women and children in clinical trials during outbreaks. All respondents concurred with the prioritization of informed consent for research during an outbreak. Based on our findings, research ethics guidance is needed to equip research stakeholders in dealing with ethical complexities arising in the conduct of research during emerging disease outbreaks-especially regarding using experimental interventions; placebo trial design; inclusion or justified exclusion of pregnant women and children; and biological sample/data sharing. The findings will be used in ongoing efforts of developing a consultative and coherent African-centric framework to support ethical conduct of research for future emerging infectious disease outbreaks in Africa.
摘要：
在疾病暴发期间进行研究可能在道德上具有挑战性，2014-2016年西非埃博拉疫情和COVID-19大流行证明了这一点。然而，在疾病爆发期间进行研究时，很少有实证研究来了解不同利益相关者对道德问题的看法和观点。进行这项初步研究是为了实证探索非洲公共卫生研究利益相关者对非洲传染病暴发期间研究伦理问题的看法。我们对参加2019年3月13日至15日在亚的斯亚贝巴举行的国际复发和新兴传染病国际会议（ICREID）的330名参与者进行了在线调查。埃塞俄比亚就2014年埃博拉疫情中经历的各种研究伦理复杂性发表了意见。研究结果揭示了在几个伦理主题上的一些分歧观点，包括：在暴发中使用未注册干预措施的伦理；可接受的研究设计；伦理审查过程；风险收益评估；排除孕妇和儿童；以及生物学样本和数据共享。大多数(76.3%)的受访者认为，在缺乏可用的标准治疗或预防方法的情况下，如果有强有力的科学依据和有利的风险-收益比,那么使用研究性干预措施在伦理上是合理的.关于高病死率暴发期间的常规安慰剂对照试验，认为这种不道德的受访者是认为这种设计在道德上是合理的受访者的三倍以上。我们感到有些惊讶的是，大多数（近60％）的受访者对在暴发期间将孕妇和儿童排除在临床试验中感到满意。所有受访者都同意在爆发期间优先考虑知情同意进行研究。根据我们的发现,需要研究伦理指导,以使研究利益相关方能够处理在新出现的疾病暴发期间进行研究时出现的伦理复杂性,特别是关于使用实验性干预措施;安慰剂试验设计;纳入或合理排除孕妇和儿童;以及生物样本/数据共享.研究结果将用于正在进行的努力，以开发以非洲为中心的协商和连贯的框架，以支持对非洲未来新出现的传染病暴发进行研究的道德行为。
