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The
Human Studies Core provides the MGH Burn Research Center with the
clinical infrastructure for study design, accrual and analysis of
data and samples from critically-ill burn patients and healthy volunteers.
The core staff facilitates the complex human studies performed at
each of our study locations: the Burn Centers at the Massachusetts
General Hospital and the Shriners Hospital for Children, the MGH PET
Camera Facility, the MGH general surgical units, and the MIT General
Clinical Research Facility.
The Human Studies Core is responsible for the development and implementation
of standard operating procedures (SOPs), recruitment and obtaining
consent of subjects, collection and distribution of samples, record-keeping,
and coordination with the subprojects. This core allows the human
research performed in our Center to be conducted with remarkable accuracy,
sensitivity, and reproducibility.
The Core acts most efficiently to prevent duplicate and unnecessary
blood drawing and testing. To anticipate maximum coordination of
research efforts and close cooperation among the project investigators,
human study information obtained from our studies on the clinical
units is effectively coordinated and organized within this core,
thereby providing an efficient mechanism of data management.
Advancement from this core is the establishment and dissemination
of guidelines, tools, and standard operating procedures (SOPs),
which can be accessed and utilized by investigators in the field
of burns and trauma. The study of burn-injured patients and healthy
volunteers is essential to our understanding of the human response
to injury. This activity requires careful oversight and quality
control to maintain maximum safety and patient protection and to
insure high-quality data collection.
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