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Federal regulations require IRBs to include at least one non-affiliated, non-scientist member on the boards, commonly known as the "community member."
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Translation of full informed consent forms into other languages can be a costly and time-consuming endeavor for researchers, particularly if there are few non-English speaking participants in a study.
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Academic and medical research institutions and their IRBs often have to deal with study proposals that fall between research and quality improvement (QI).
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A large health system IRB found that incomplete study submissions were clogging up the IRB review system, resulting in long waits up to three months for approval.
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The patients who come into hospitals are often very ill and not in the best state. But give them a chance to help improve care, and if they are able, they are almost always willing.
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It's doubtful that anyone goes into the Baldrige process looking for a site visit the first year.
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You join a collaborative because you want access to data and ideas. Together you might find something out that individually you could not. That's the theory. And it works.
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The rapid growth of image-guided surgery has revolutionized procedures and reduced recovery time for patients, but it has increased risks of radiation exposure to the operating room staff.