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In its proposed revision of the Common Rule, the U.S. Department of Health and Human Services is considering the most extensive changes to human subjects protection regulations in decades.
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The most recent statistics gathered from the Association for the Accreditation of Human Research Protection Programs' (AAHRPP) client institutions don't look all that different from the baseline metrics released last year.
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Researchers studying whether specially padded underwear protected elderly wearers from hip fractures came up with a one-sided garment design that allowed them to compare the results of a padded hip and an unprotected hip on the same person.
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The Advance Notice of Proposed Rulemaking (ANPRM) proposes extensive changes to the way that exempt and expedited studies are currently handled, with an emphasis on streamlining the process for researchers who conduct minimal risk activities, particularly in the social sciences.
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In a quick-moving, high-volume area such as the emergency department (ED) of Botsford Hospital in Farmington Hills, MI, communication breakdowns are bound to happen between patient access and clinical staff.
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More often, patient access financial counselors find themselves in the unenviable position of telling patients about out-of-pocket responsibilities running into the thousands of dollars.
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Almost all private plans now require authorizations for radiology services, reports Richard J. Suszek, director of patient access at Barnes-Jewish Hospital in St. Louis, MO, and Missouri Medicaid began requiring authorizations in July 2010.
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While no one disputes the need for IRB reviews and their importance in reversing decades-old trends of human subjects abuses, some say IRBs often ignore the risks of delaying or rejecting research by overstating the risks to human subjects.
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As researchers and IRBs navigate the brave new world of Internet research, it's tempting to lump various types of research venues together applying the same rules to social media networks such as Facebook that they use for Internet chat rooms and blogs.