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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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Researchers using the Internet for recruitment and for electronic surveys have discovered that problems with online fraud can undermine the ease and efficiency of Web-based recruiting, an expert says.
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Researchers and physicians are increasingly speaking out on the issue of the geriatric population being excluded from clinical trials.
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To ensure that a proposed study or clinical trial can fulfill its goals and remain within ethical guidelines, some IRBs have mandated that protocols go through scientific review prior to submission. The purpose of the review is to ensure that studies are built on a solid scientific foundation to achieve the objectives.
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Informed consent forms have one very daunting characteristic: They are visually numbing.