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Emergency medicine -- like the media and the global marketplace is being delivered at the increasing speed of rapidly changing technology. However, regulations for conducting emergency medicine research are strictly old school.
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The Department of Health and Human Services (HHS) current regulations regarding a waiver of informed consent in emergency medicine include the following key points:
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For most researchers the sudden departure of a study coordinator who leaves months of uncollected data is what might happen in a particularly bad dream.
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Electronic research management is transforming the way researchers work, communicate, and execute studies. It's also making the clinical trial (CT) process more efficient, flexible, and faster, says Al A. Cecchetti, PhD, co-director of the Clinical Pharmacology Data Center at the Center for Clinical Pharmacology, University of Pittsburgh Department of Medicine in Pittsburgh, PA.
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Public notification under an informed consent waiver for emergency research can be a tricky business. After investigators engage in community consultation and the IRB concludes their efforts were successful, then they need to notify the public about the study and its waiver from informed consent.
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Electronic information technology is paradoxically shrinking even as it expands its global reach. Apple CEO Steve Jobs recently predicted that more people in coming decades will be using small hand-held computer devices than will continue to use desktop computers.
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Clinical research sites increasingly will find sponsors or clinical research organizations (CROs) unwilling to send work their way unless they meet electronic and technological communication standards, experts suggest.
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Utilization of computed tomography (CT) scans has increased markedly in the past decades. It is estimated that more than 75 million scans are performed annually in the United States, compared to only 3 million in 1980.
