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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 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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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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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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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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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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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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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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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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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.
