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Telemedicine Journal and e-Health
Article . 2011 . Peer-reviewed
License: Mary Ann Liebert TDM
Data sources: Crossref
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Data Safety and Monitoring for Research Involving Remote Health Monitoring

Authors: Karen A, Kovach; Jill Ann, Aubrecht; Mary Amanda, Dew; Brad, Myers; Annette Devito, Dabbs;

Data Safety and Monitoring for Research Involving Remote Health Monitoring

Abstract

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.

Related Organizations
Keywords

Human Experimentation, Remote Consultation, Electronic Health Records, Humans, Computer Security, Confidentiality, Medical Informatics

  • BIP!
    Impact byBIP!
    selected citations
    These citations are derived from selected sources.
    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    11
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Average
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Average
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Average
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
11
Average
Average
Average
bronze