Data safety and monitoring for research involving remote health monitoring.
Data safety and monitoring for research involving remote health monitoring.
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涉及远程健康监测的研究的数据安全和监测。
DOI：
10.1089/tmj.2010.0219
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发表时间：
2011
期刊：
影响因子：
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通讯作者：
Dabbs,AnnetteDevito
中科院分区：
文献类型：
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作者：
Kovach,KarenA;Aubrecht,JillAnn;Dew,MaryAmanda;Myers,Brad;Dabbs,AnnetteDevito
进行涉及人类受试者的研究的研究人员有义务保障研究参与者的福祉。除了要求调查人员建立持续监测和报告不良事件的程序外，联邦法规并没有规定应该如何确保人类受试者的安全。根据研究的性质、规模和复杂性，各种数据安全监控(DSM)程序可能是可接受的。然而，缺乏为此类研究制定和实施适当的需求侧管理计划的实际指导。在本文中，我们回顾了与远程监控健康相关的需求侧管理注意事项，并将Pocket Personal Assistant for Tracing Health项目描述为如何为使用远程健康监控设备捕获临床数据的研究制定有效的需求侧管理计划的范例。保护参与者的安全和福利是涉及人类受试者的研究的最重要任务之一。研究人员有道德和科学责任来监测研究参与者的安全。调查人员通常通过监测和报告不良事件来履行这一责任。
Investigators conducting research involving human subjects are obligated to safeguard the wellbeing of the study participants. Other than requiring investigators to establish procedures for ongoing monitoring and reporting of adverse events, federal regulations do not dictate how human subject safety should be ensured. A variety of data safety monitoring (DSM) procedures may be acceptable depending on the nature, size, and complexity of the study. However, practical guidance for establishing and implementing appropriate DSM plans for such studies are lacking. In this article, we provide a review of the DSM considerations associated with monitoring health remotely and describe the Pocket Personal Assistant for Tracking Health project as an exemplar for how to develop effective DSM plans for research that captures clinical data using remote health-monitoring devices. Protecting the safety and welfare of participants is one of the most important mandates for research involving human subjects. Investigators have an ethical and scientific responsibility to monitor the safety of research participants. Investigators typically fulfill this responsibility by monitoring and reporting adverse events.