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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.
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Local context and the targeted populations' particular issues are important when research institutions strive to improve their human research subjects protection. IRBs and their mandate to include community members help meet this challenge.
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The proposed Common Rule changes that would permit a central IRB to review multiple site studies drew passionate responses both for and against the change in the early comments submitted to the U.S. Department of Health and Human Services (HHS).
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For years, federal regulations have deemed the research use of deidentified blood and tissue samples collected in clinical procedures to be non-human subjects research, and therefore has not required informed consent from the patients from whom they were taken.
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IRBs wrestling with mounting numbers of adverse event (AE) reports have been encouraged to get a handle on which items need to be reported and which don't. But often, that choice isn't only up to the IRBs study coordinators will submit items even when they're told they don't have to.
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When Vanderbilt University's BioVU biobank considered whether to add pediatric biospecimens to the adult samples already being gathered, officials faced a range of ethical questions.
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An in-depth review of consent forms provided to volunteers for HIV/AIDS research in the United States and abroad about study procedures, risks, and benefits has found that the forms were extremely long and used wording that might have been complex enough to hinder full understanding, according to bioethicists at The Johns Hopkins University in Baltimore, MD.
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About 25% of all Americans who are dying are veterans. Yet only 4% of dying veterans die within the Veterans Affairs (VA) Healthcare Network; most veterans are cared for by hospice and healthcare professionals in the community.