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The history given to Melea Anderson, DNP, MS, RN, CNP, critical care practice lead/trauma program manager at Children's Hospitals and Clinics of Minnesota in Minneapolis, seemed straightforward. The parent stated that the child had had ear pain for the last week, with no fever or other symptoms.
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Would it surprise you to learn that delays in treatment for stroke patients in the emergency department haven't changed significantly in the past few years?
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A young mother presented to an ED with abdominal pain, tachycardia, and hypotension, but after 45 minutes, she still had not been seen.
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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.
