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IRB offices might improve their staff and IRB members' training and education if they provide an occasional refresher course on the National Institutes of Health (NIH) Guidelines for the Conduct of Research Involving Human Subjects, also known as the Rules of Review.
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Practice-based researchers have long complained that IRBs don't understand their work, which is based in physicians' practices and often consists of low-risk activities such as chart reviews and surveys.
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[Editor's note: Wendy Lloyd, LPN, CCRP, CIP, regulatory affairs and compliance specialist, at Vanderbilt University Medical Center in Nashville, TN, has compiled a list of frequent audit findings of the informed consent document process. She answers questions for IRB Advisor about these findings in this question and answer session.]
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When IRBs and research organizations' quality improvement offices work together, the net effect is a more thorough and efficient human subjects research process, experts say.
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Applying community engagement to mental health research can help researchers about design studies that incorporate the priorities of people with mental illness and arrive at the best strategies for working with them.
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All IRBs and IRB offices need to set up succession plans to ensure continuity in the event the IRB director or chair leave abruptly.
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Researchers say there need to be more clinical trials examining the safety and effectiveness of pain medications used with children, which are too often administered based on information from adult trials.
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An IRB dedicated to handling cancer research has shown benefits in efficiency and expertise when such a specialty IRB model is employed.
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Major research institutions can improve their IRBs' efficiency and protocol review quality by making the best use of a resource they have in abundance: expert professors and scientists.
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Seeing a need for ethics guidance for local groups attempting to conduct community-based research, an organization in Kitchener, Ontario, has created an independent Community Research Ethics Office (CREO).