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The Agency for Healthcare Research and Quality (AHRQ) has issued a notice about its expectations with the completion of grants awarded from the funding provided by the American Reinvestment and Recovery Act (ARRA). Among the key points:
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With the creation of the Clinical and Translational Science Awards (CTSA) program, the goal of involving the community in research has drawn more support and interest.
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Adaptive design clinical trials raise many of the same issues in IRB review as do unplanned modifications to existing trials, says Marjorie Speers, PhD, executive director of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in Washington DC.
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As Americans become increasingly accustomed to learning more about their own health, it's becoming more common for research participants to expect to learn about their personal results during a study.
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For researchers and IRBs there is an ethical paradox in behavioral studies involving populations that are hard to engage.
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A 57-year-old nursing home resident with a history of dementia climbed out the open window in her room, falling 30feet to the ground below. The woman suffered severe injury as a result of the fall, and a jury awarded the plaintiff $276,164 in damages.
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A pregnant woman at full term presented to the hospital for the birth of her son. The baby was delivered via Caesarean section. Normal tests were conducted on the newborn, and all seemed to be in order.
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Gaining patient consent and provider adoption for health information exchanges (HIEs) is important for the success of the effort, and patients must be adequately educated about the HIE or they may not give their permission, says Jared Rhoads, senior research analyst with CSC, a technology consulting company based in Falls Church, VA.
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Resident elopement and wandering can be extremely dangerous for patients and costly to the facility if the patient is injured or dies, but many health care providers do not have a formal plan in place to prevent the problem or respond effectively once staff realize a patient is missing.