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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 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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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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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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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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Early antibiotic administration was associated with reduced likelihood of death, mechanical ventilation, and readmission (but increased risk of Clostridium difficile infection) among patients hospitalized for acute exacerbations of COPD.
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Serious infections caused by Acinetobacter baumannii are appearing in the community, spread by patients who acquired the organism in the hospital setting, and conversely, the organism is being introduced into the hospital from long-term nursing care patient settings. Resistance to antimicrobial agents has increased over the six-year study period, along with the severity of disease.
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The use of angiotensin converting enzyme (ACE) inhibitors in all acute myocardial infarction (MI) patients is controversial. Thus, these investigators from the Register of Information and Knowledge about Swedish Heart Intensive Care Admissions (RIKS-HIA) examined the association between ACE inhibitor therapy and mortality in unselected patients with acute MI.
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In this retrospective study of patients hospitalized because of severe chronic liver disease, venous thromboembolism was relatively common and "auto-anticoagulation" in the form of an elevated INR had no apparent protective effect.
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