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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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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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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.