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A pilot program of a web-based system for reporting adverse events in clinical trials already has shown itself to be a timesaver for study staff at the Dana Farber/Harvard Cancer Center.
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From a renewed push for a mandatory clinical trials registry to a new secretary of Health and Human Services, the political landscape promises to keep IRBs and others involved in protecting human research subjects busy.
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Two-thirds of Americans believe that clinical research is safe for people who participate in them, according to a survey by the Center for Information and Study on Clinical Research Participation (CISCRP) and Opinion Dynamics Corp. (ODC).
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New ethics guidelines rolled out by the National Institutes of Health (NIH), aimed at repairing a damaged public image, angered employees and could create internal problems for the organization.
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An effective compliance oversight process can nip noncompliance problems in the bud acting quickly to handle small problems before they get bigger, even preventing future noncompliance from occurring.
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The patchwork of call panel arrangements is unwieldy, expensive, and may compromise the quality of care for patients in the emergency department. This dramatic finding is part of a new report that outlines the seriousness of the call panel situation in California, often considered to be a state that precedes the rest of the country, and offers recommendations to remedy the situation.
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Caught between the proverbial rock and a hard place, the University of Mississippi Medical Center (UMC) in Jackson has taken drastic action and announced that on a case-by-case basis, it may decide not to accept future transfers from facilities it believes have the resources to care for those patients themselves. But in so doing, UMC may have put itself in danger of violating the Emergency Medical Treatment & Labor Act (EMTALA), says one expert.
