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Planning for disaster response generally has overlooked the special needs of people who suffer from pre-existing and serious mental conditions, say bioethicists at Johns Hopkins University in Baltimore, MD. Survivors already diagnosed with schizophrenia, dementia, addictions, and bipolar disorder are vulnerable long before a disaster strikes, they point out.
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The perceived role of God in illness and recovery is a primary influence upon the healthcare beliefs and behaviors of American Muslims, a recent study has discovered. Outreach and education efforts by the healthcare community can help address Muslim concerns and improve healthcare quality in this rapidly growing population, the report recommends.
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According to a recent study in The Journal of the American Medical Association (JAMA),1 a simple blood test can determine a baby's sex as early as seven weeks into pregnancy is highly accurate if used correctly.
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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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Seemingly, no one is happy with his or her block schedule at the hospital or the surgery center. After spending too much time on this issue with our own centers and hearing about others concerns, it is, quite honestly, irritating that such a simple process can be such a conundrum for most everyone.
