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IRBs run on data and paper and lots of it. Some organizations may find themselves running out of space to store the reams of paper that are needed to catalog the scores of research and submission data. This has led some IRBs to look for alternative methods of data storage. But an IRB cant live without paper or can it?
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Drugmaker GlaxoSmithKline (GSK) has announced its intentions to start publishing clinical study reports (CSRs) and clinical trial results in an effort for increased transparency, making it the first major drug company to do so.
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In days not so long ago, when all IRB members received heavy stacks of paper packets containing protocol submissions before each meeting, research institutions and regulatory compliance officials never questioned whether they would read the work before meetings. It was assumed they would be well-prepared for discussions.
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As research institutions become more thoroughly electronic in their IRB and clinical trial systems, they should not lose sight of the importance of securing all transmitted data, an expert says.
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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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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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Bioethics, genetic research also addressed at annual conference
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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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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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In June 2011, representatives from various IRBs and federal regulatory bodies met to discuss the development of a new model to improve the multisite study model.