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IRBs and human research protection staff engage in important, sometimes life-protecting work. Their purpose and goals are on high ethical and moral ground. So its easy to forget that its also an enterprise with clients or customers to satisfy.
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It is a natural electronic data evolution: First, IRBs began using electronic data systems; then these morphed into full electronic submission, and now IRBs are collecting valuable electronic, real-time data that can be mined very quickly for process and quality improvement purposes. Metrics are key to this transition.
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A new study has found that while nine out of 10 clinical trials worldwide meet enrollment goals, reaching those goals could mean doubling original timelines.
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To better clarify the IRBs position in investigating clinical investigators and sites for clinical trials, the Food and Drug Administration (FDA) has released draft guidance for reviewing those qualifications.
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The University of California at Berkeleys Consent Builder application relies on the simplified language and template structure previously developed by the institutions IRB office.
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Sometimes an IRB director will notice that board members lack interest in evaluation processes. Any attempt to assess how each member is doing might be shuffled to the back burner of the schedules of very busy people.
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A new research ethics program seeks to repair problems when investigators misbehave or are in noncompliance.
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The American Association of University Professors (AAUP) released a report taking IRBs to task over what they call inappropriate, indeed absurd, alterations in research protocols and overly stringent guidelines for study submission and approval.
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Years of improvements to the informed consent process and many hours of developing tools and templates to assist IRBs and investigators in fine tuning informed consent documents have helped pave the way for Consent Builder.
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While monstrous hurricanes are not a frequent occurrence, it always pays to be prepared. Hurricane Sandy was something of an anomaly, but cities and hospitals in the Northeast braced for the monster hurricane, putting plans in place to evacuate patients when needed and ways to continue operations even if the worst happened.