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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.
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The Food and Drug Administration (FDA) has received many lengthy comments expressing concern about its recent draft guidance for IRBs, investigators, and sponsors regarding assessing the qualifications of investigators.
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The University of Alabama at Birmingham (UAB) was the most recent in a small list of institutions that received letters of determination from the Office for Human Research Protections (OHRP) of Rockville, MD, about allegations of noncompliance.
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The research oversight system, says a University of North Carolina at Chapel Hill researcher, has not evolved to keep up with the volume and complexity of the research it oversees.
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IRBs increasingly will have to adjust to collaborative approaches in research, including working with community partners and other stakeholders, experts say.
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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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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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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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Use documents as proof you talked to patients
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Continuing to stress the importance of discharge planning and preventing unnecessary readmissions, the Centers for Medicare & Medicaid Services (CMS) has issued a revised set of Discharge Planning Interpretive Guidelines that surveyors will use to assess a hospital's compliance with Medicare's Conditions of Participation. The guidelines do not apply to critical access hospitals, which must follow a different set of Conditions of Participation.