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The Office for Human Research Protections (OHRP) in Washington, DC, is indicating to research institutions that the agency favors the use of centralized IRBs for multisite studies.
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When the federal Office of Human Research Protections raised questions about a quality improvement (QI) initiative to reduce catheter infections in Michigan hospitals in 2007, it reignited a debate over the line between QI and human subjects research necessitating IRB review.
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Based on a survey of research participants, the office of research compliance and quality improvement at Cedars-Sinai Medical Center in Los Angeles, CA, has come up with these four key areas to demonstrate informed consent.
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Research institutions increasingly are turning to central IRBs for multisite clinical trials, and this trend probably will accelerate due to recent news that federal regulators are encouraging the change, experts say.
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In this issue: Aggressive approach to CVD reduces MI, folic acid and vitamin B12 for CAD, corticosteroids for acute exacerbations of COPD, prescription drug abuse among young adults, and ARBs and cancer risk.
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A number of reports on dengue have been published recently in the Morbidity and Mortality Weekly Report. The CDC described dengue surveillance in the United States using two sources of data: 1) specimens tested at the CDC Dengue Branch (CDCDB); and 2) the ArboNET surveillance system of the CDC Arboviral Diseases Branch.
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Murray and colleagues provide a rigorous description of child mortality in 187 nations of the world.
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A 39-year-old man had traveled for four weeks to the Pantanal region of Brazil, a popular ecotourism area, where he had walked barefoot on several occasions. Ten days before returning to the UK, he noted painful lesions on his feet that were white/pale yellow with a central black punctum.