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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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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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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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In an effort to address the wide variance in state laws and policies regarding the research use of newborn screening blood spots, a federal advisory committee is considering a proposal for a national policy.
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More than 75% of parents surveyed in a nationwide study would be willing to allow their children's newborn screening samples to be used for future research if researchers first asked their permission.
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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.
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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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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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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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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.