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Federal officials today released two policy documents that lay out stricter requirements for institutional and government oversight of studies that pose especially problematic safety concerns.
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PB conceived of the study, and provided detailed oversight of study design and data analysis.
WJB participated in the oversight of study implementation and the statistical analysis.
KCH participated in the recruitment of participants, the oversight of study implementation and the statistical analysis.
RAA was the PI on the study and was responsible for the design and oversight of study execution and analysis.
MM conceived of the study and was responsible for oversight of study design and conduct, interpreting the results, and manuscript revisions.
AFB was the principal investigator of this study and involved in oversight of study design, data collection and analysis, and manuscript preparation/review.
AR developed the TIA/Stroke EDS, designed the study, had overall oversight of study and final analysis/interpretation of data, and drafted the manuscript.
The clinical director of the study (principal investigator) is responsible for research personnel hiring and training, informed consent procedures, participant selection, clinical assessments, management of adverse events, data management, and general oversight of study procedures.
Some outside scientists, however, say the report's apparent endorsement of greater government oversight of such studies may not be enough to ensure public safety.
The new agency, which would also be charged with ethical oversight of clinical studies, could facilitate better use of patient data by researchers, the report says.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com