IRB Advisor – March 1, 2015
March 1, 2015
View Issues
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Single IRB NIH guidance may leave more questions than answers
In December 2014, the National Institutes of Health (NIH) released draft guidance detailing its support and expectations for the use of a single IRB for multisite NIH-funded studies. But for many in the IRB community, the guidance raised more questions than answers.
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Certification testing can be more successful, less stressful with study group method
As IRB professionals increasingly invest in their careers and seek certification, they sometimes find that taking the certification test can be stressful and all-consuming.
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Here’s what a certification study group program looks like
The only thing better than forming an in-house IRB certification study group is forming a multi-institutional IRB certification group, according to a pair of IRB managers who found good results with their three-institution CIP study group.
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Study: Clinical trial site violations not reported in peer-reviewed literature
A study published in JAMA Internal Medicine in February found that serious violations of good clinical practice discovered by the Food and Drug Administration (FDA) at clinical trial sites are not mentioned in peer-reviewed publications in which the trial results are published.
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How do IRBs or PIs Rate the Risk of Ordinary Life Experiences?
What might bring emotional distress to one person could be a shoulder-shrug to another.
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Comic assent/informed consent for biobanking is accessible
As IRBs continue to evaluate informed consent (IC) and youth assent forms according to regulatory guidelines and readability, researchers have come up with a format that engages, informs, and even entertains people being asked to participate in biobanking: comic assent.