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They made every list, accolades coming left and right. A safety culture had been born and bred and things were looking good for Memorial University Medical Center in Savannah, GA.
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The Joint Commission issued its first sentinel event alert in August 2009. The issue: Leadership's role in committing to safety and promoting quality care.
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Though the utility of the rapid response team on decreasing mortality has been questioned in recent literature, no one disputes the importance of early recognition of patient deterioration or subsequent early intervention.
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It's a constant refrain: IRBs are overburdened by adverse event reports (AERs) â many of which are unnecessarily reported to them and which they often lack the information to properly analyze.
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Handling mental illness during pregnancy can be a double-edged sword. Because of the scarcity of clinical research with pregnant women, there are no FDA-approved medications for treating such illnesses. On the other hand, untreated mental illness in pregnancy carries its own risks.
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Requirements that IRBs see as minor or routine may have serious consequences for a practice-based research network (PBRN), says Barbara P. Yawn, MD, MSc, FAAFP, director of research at Olmstead Medical Center, Rochester, MN.
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When a Yale University research facilitation office first looked at improving protocol review turnaround time in late 2007, the time from intake, through development, to IRB submission and approval averaged 80 days.
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IRBs and researchers now have a new toolkit that will make it easier to ensure proper informed consent has been obtained from subjects with limited literacy and proficiency in English.
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"The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research," published in September, 2009, provides very concrete examples of ways investigators and IRBs can improve the informed consent process.
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A study of serious adverse event reports (AERs) sent to an IRB from clinical trials of a breakthrough cancer drug revealed they were too often incomplete and inaccurate when compared to the original medical records from which they were taken.
