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IRBs frequently worry that questioning subjects who have undergone physical or emotional trauma can cause distress, but research has shown that such questions do not tend to cause additional damage to subjects.
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As the technology that enables genetic research becomes more sophisticated, it opens a kind of Pandora's box to researchers telling us information about subjects that they weren't looking for and may not necessarily want to know.
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One of the key attributes of a strong human research protection program is an institution's ability to optimize its resources, an expert says.
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Many researchers have stories about the challenges of getting reviews from multiple IRBs for a study the differing standards, varying risk assessments and the duplicated paperwork.
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IRBs have full schedules, and the little mistakes investigators make when applying for an approval can bog down the process, adding weeks and resulting in wasted time. As one IRB office has discovered, a solution that can reduce turnaround time and improve efficiency involves the use of a pre-review screening process.
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IRBs continue to see informed consent (IC) forms that require high school or college reading skills when nearly half of Americans can read no higher than a 5th grade level, an IRB chair says.
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When Jill Matzat was monitoring clinical studies, she approached it the way she had approached her work in the lab and as a nurse.
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Captive insurance agencies require the insured to take on more claims risk, but that risk is not unlimited. Even with a captive, you don't risk paying entirely out of pocket for a major claim or repeated claims in one year, says Christopher M. Keith, a producer with The Graham Co. in Philadelphia.
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Healthcare leaders have to worry about complying with plenty of industry-specific requirements and the potential cost when a whistleblower reports malfeasance. Another risk, however, comes from the broader world of corporate fraud.