The impact of the COVID-19 pandemic response on other health research
The impact of the COVID-19 pandemic response on other health research
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DOI：
10.2471/blt.20.257485
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发表时间：
2020-09-01
影响因子：
11.1
通讯作者：
Bukusi, Elizabeth Anne
中科院分区：
文献类型：
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作者：
Singh, Jerome Amir;Bandewar, Sunita V. S.;Bukusi, Elizabeth Anne
尽管各国政府一直在关注2019年冠状病毒病(新冠肺炎)对全球经济造成的前所未有的破坏，以及对新冠肺炎研究的迫切需求，但其他健康研究已经成为这场大流行的牺牲品。与新冠肺炎无关的主要研究活动已大幅减少或完全暂停，原因要么是新冠肺炎相关的法律限制，要么是后勤、人员配备或运营方面的担忧。目前，全球有数十亿人受到封锁或宵禁的影响。由于这种限制性措施的时间范围尚不清楚，而且可能会发生变化，许多研究现在处于悬而未决的状态，数万名研究参与者的福利面临风险。这些情况带来了复杂的道德挑战，值得国际赞助商、研究人员和监管机构紧急关注。某些发起人和监管机构已发布指导意见，说明应如何管理新冠肺炎对临床研究的干扰。尽管这些指导方针为应对不断演变的大流行的挑战提供了一个良好的起点，但它们只适用于由这些机构资助或管理的研究人员。在这里，我们提供了适用于这些特定设置之外的此类中断的管理指南。我们重点介绍了新冠肺炎疫情对其他正在进行的与新冠肺炎无关的研究项目的影响，并就如何管理受影响研究参与者的福利提供了实用指导。我们的结论是，政策制定者、赞助者、研究人员和监管机构必须采取更灵活的方法，以确保参与者的安全，同时保持数据完整性并遵守良好的临床实践。
While governments have been focusing on the unprecedented disruption to the global economy caused by coronavirus disease 2019 (COVID-19) and the urgent need for COVID-19 research, other health research has become a casualty of the pandemic. Major research operations that are unrelated to COVID-19 have been significantly diminished or suspended entirely because of either COVID-19-related legal restrictions or logistical, staffing or operational concerns. Billions of people globally are currently affected by lockdowns or curfews. Since the timescale of such restrictive measures is unknown and subject to change, many studies are now in limbo and the welfare of tens of thousands of study participants is at risk. These circumstances have introduced complex ethical challenges that merit urgent attention from international sponsors, researchers and regulators. Certain sponsors and regulators have published guidelines on how the COVID-19-related disruptions to clinical research should be managed. Although these guidelines provide a good starting point in navigating the challenges of the evolving pandemic, they only apply to those researchers funded or governed by these bodies. Here, we provide guidelines on managing such disruptions that apply beyond these specific settings. We highlight some of the effects of the COVID-19 pandemic on other ongoing research projects that are unrelated to COVID-19 and provide practical guidance on how the welfare of affected study participants should be managed. We conclude that policy-makers, sponsors, researchers and regulators must adopt a more flexible approach to ensure participant safety, while maintaining data integrity and complying with good clinical practices.