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As bioethicists and other experts in human subjects research protection take a closer look at the IRB's role, two interesting questions emerge: First, how can IRBs improve their risk-benefit analyses of trials, and, secondly, should IRBs even be in the business of making risk-benefit determinations?
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The use of deep brain stimulation (DBS) in the treatment of Parkinson's disease and other neurological disorders has been the subject of many research studies and has been approved by the Food and Drug Administration since 1997.
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Written informed consent will exist in human subjects research for as long as regulations require it, but this doesn't mean IRBs and investigators are stuck within its limitations.
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It's likely one of the first medical procedures most newborn babies undergo a simple heel stick, as blood samples are taken to screen for a variety of disorders that might not otherwise be apparent at birth.
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Human subjects research has evolved and grown dramatically in recent decades, fueled by advances in medical technology, research globalization, and financial and professional incentives, a researcher and health science expert says.
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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.
