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For decades, IRBs and ethics panels have lamented the sorry state of informed consent documents.
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Protecting the identities and sensitive information of study subjects is one of the top priorities in research, particularly if a study involves topics that could be damaging to a subjects reputation.
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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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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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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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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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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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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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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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One of the biggest challenges IRBs face is keeping up with ethical issue updates during an ever-evolving period technologically, experts say.
