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Within one year of opening its doors in 2009, Opus IRB of Roswell, GA, had its first research review, and within the last year the independent IRB achieved full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC.
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Physicians often are engaged in a research study at some point in their careers, but if they're working in the community primarily as clinicians they might not receive optimal mentoring and training in protecting human research subjects.
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More than a year after the Department of Health and Human Services released its proposed rewrite of the Common Rule, researchers and IRBs still are waiting for the other shoe to drop.
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As institutions wait to find out what comes out of the ANPRM, there are steps they can take now to work within the current regulations and achieve the Department of Health and Human Service's goals of lessening the burden on investigators and IRBs while still protecting subjects.
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While many IRBs complain about the quality of informed consent, there's been little substantive research into how to improve it, particularly for subjects with low literacy, says a researcher who has studied the issue.
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Accreditation standards regarding community outreach and education encompass just two short paragraphs and elements in the standards written by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC.
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Like many other institutions, the Children's Hospital of Philadelphia often struggled to get and keep good IRB members. Its roster was full of busy physicians who couldn't make all the meetings, and some had to rotate off the board because of the demands of their work.
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In what is getting to be a familiar, tragic refrain, the improper use of single-dose vials (SDVs) has resulted in pain clinic patients in Arizona and Delaware acquiring serious bacterial infections that were "completely preventable," the Centers for Disease Control and Prevention (CDC) reports.
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Whether it's the smartphones, tablet computers, or e-readers, new technology is all the rage these days. At the Shriners Hospitals for Children in Erie, PA, this mobile technology is being used to help patients.
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The Accreditation Association for Ambulatory Health Care (AAAHC) has announced an accreditation program that is tailored to the specific needs of practices that offer office-based surgery (OBS), and it is priced to be cost-effective for smaller practices. AAAHC defines an OBS center as an organization that has no more than four physicians/dentists and no more than two operating/procedure rooms.