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Research institutions might begin any new or improved compliance program by following the seven elements of an effective compliance program that are part of the Office of Inspector General (OIG) compliance guidance for hospitals, an expert advises.
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After years of training that results in physicians and researchers speaking in a way that is at best challenging for patients to understand, they now can learn how to talk like a layperson.
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The PRISMProject to Review and Improve Study Materialshas developed a quick reference guide for improving readability in informed consent and other research documents.
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The human research protection program at Vanderbilt University of Nashville, TN, has created a flow chart that assists investigators with making decisions about how to insert cost language in study informed consent forms.
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Research institutions put considerable time and resources into developing informed consent (IC) templates and tools to assist researchers as they seek ethics board approval, but they sometimes neglect to focus on the part that describes cost to participants.
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Cato Research, a clinical research organization (CRO) in Durham, NC, maintains a database and metrics on all studies, continually comparing sites' predicted study enrollment with their actual performance.
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The clinical research industry's well-documented inefficiency is like a rhinoceros stampede: everyone recognizes it, regrets it, but can't figure out how to stop it.
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Make sure your health care workers are handling hazardous drugs safely.
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Latex gloves are back on the public agenda. The U.S. Food and Drug Administration has issued a proposed warning label for powdered gloves and is considering a ban on the use of powder in latex gloves and alternatives, even as hospitals greatly reduce their use of powdered gloves.