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Saints Medical Center in Lowell, MA, announced recently that it will pay $579,000 to settle alleged Medicare billing violations, the first settlement since the publication of the Centers for Medicare and Medicaid Services (CMS) voluntary self-referral disclosure protocol (SRDP).
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A mother took her 4-year-old daughter to the emergency department with symptoms of gagging and watery diarrhea. The physician caring for the child determined that the child was not suffering from dehydration and provided a prescription for the child's nausea. The child's symptoms worsened. After the parent was told by the hospital to allow the medicine additional time to work, the child died. A verdict was entered against the hospital in the amount of $200,000.
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Hundreds of obstetrical nurses, midwives, residents, and doctors completing an intensive continuing education program focused on risk management are helping their hospitals lower professional liability costs through an obstetrics-intensive patient safety program.
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Can the informed consent process actually provide too much information?
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A data and safety monitoring board (DSMB) can be crucial to protecting participants in higher-risk studies, by reviewing the accumulating study data for potential emerging risks and if necessary, by recommending that a study be changed or even halted as a result.
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First-in-human clinical trials raise difficult ethical issues for researchers and IRBs because of the uncertainty that accompanies them. Did the preclinical studies that preceded them provide enough information about effectiveness and risks and benefits to proceed with human volunteers?
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IRB application submissions often lack consistency, have omissions and errors, and other problems that IRBs should teach investigators to anticipate and correct before filing their application. Among these mistakes are policy errors, data security concerns, and other procedural problems.
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The Vice President's Office for Research at Virginia Commonwealth University in Richmond, VA, has developed a formal process for investigators who wish to appeal an IRB determination.
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A recent lawsuit against Brown University in Providence, RI, is an important sign that it's time for research institutions to create formal appeals processes in the event of contested IRB review decisions.
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As a research institution's human subjects research increases, so must an IRB's work. In some cases this means expanding to handling multicenter protocols, which bring may result in new challenges.
