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When human subjects research directors finish sifting through the proposed Common Rule changes, they likely will find some things they can live with and plenty of others they'd like to modify.
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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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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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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.
