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There is no question that hospitals face innumerable challenges in meeting the "meaningful use" of health information technology (HIT) criteria established by the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009.
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Over the last 20 years, the typical American has seen exposure to ionizing radiation double. Most of the time, patients are sent for imaging without the prescribing physician having any idea of how much other radiation the patient has been exposed to.
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Florida has joined a rarified group of states that provide no protection for any documents produced as part of peer review for non-physician providers.
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IRB directors who think their areas are safe from natural disasters should think again. Some U.S. IRBs learned the hard way that even in non-coastal cities and areas they can find their IRB offices underwater. Or they could experience earthquakes, tornadoes, hurricanes, and fires. And any research institution and IRB is at risk of an epidemic that leaves them short-staffed.
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Therapeutic misconception in clinical trials continues to be a significant concern for researchers and IRBs. Studies have shown that misunderstandings persist about the therapeutic value of research interventions among participants and even among research staff.
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IRB offices might improve their staff and IRB members' training and education if they provide an occasional refresher course on the National Institutes of Health (NIH) Guidelines for the Conduct of Research Involving Human Subjects, also known as the Rules of Review.
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Practice-based researchers have long complained that IRBs don't understand their work, which is based in physicians' practices and often consists of low-risk activities such as chart reviews and surveys.
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[Editor's note: Wendy Lloyd, LPN, CCRP, CIP, regulatory affairs and compliance specialist, at Vanderbilt University Medical Center in Nashville, TN, has compiled a list of frequent audit findings of the informed consent document process. She answers questions for IRB Advisor about these findings in this question and answer session.]
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When IRBs and research organizations' quality improvement offices work together, the net effect is a more thorough and efficient human subjects research process, experts say.
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Previously, case managers at University of Louisville (KY) Hospital were assigned by service, and "they were all over the place," says Mary G. Lawson, BSN, MPA, director of admissions.