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Experts say IRBs spend much of their time discussing informed consent issues and nuances, and yet this is the area cited most often in recent regulatory letters sent to research institutions.
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The Food and Drug Administration (FDA) has now said that clinicians wishing to perform a fecal transplant for treatment of Clostridium difficile will have to obtain an investigational new drug (IND) application.
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Bioethics, genetic research also addressed at annual conference
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Too often, IRBs spend precious meeting time debating the merits of a studys scientific and other subjective fine points, overlooking issues that have a greater impact on human subject safety, experts say.
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An issue that can frequently arise in the area of genomic research is what to do with incidental findings (IFs) discoveries concerning a research subject that are beyond the scope of the study, but could have potential health importance for the subject.
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IRBs searching for highly effective ways to improve protocol submissions and enhance education and training efforts might check out the SWAT! program at Washington University in St. Louis.
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In the age of smart phones, iPads, electronic checklists, text message reminders, and other tools, it would be easy to forget that sometimes the best solution is the simplest: no-tech. At least thats what one research and human subjects protection expert discovered when trying to find a way to improve IRB meeting and review quality.
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IRB cheat sheet placemats provide IRB members with clear regulatory information for reference during IRB review meetings.
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Registrars at Georgia Regents University in Augusta work side by side with utilization review/precertification nurses to prevent claims denials.
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All conversations that come into central scheduling are recorded and are used for two purposes, says Mike Horton, manager of the central scheduling department at Hackensack (NJ) University Medical Center.
