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Adaptive design clinical trials raise many of the same issues in IRB review as do unplanned modifications to existing trials, says Marjorie Speers, PhD, executive director of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in Washington DC.
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As Americans become increasingly accustomed to learning more about their own health, it's becoming more common for research participants to expect to learn about their personal results during a study.
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For researchers and IRBs there is an ethical paradox in behavioral studies involving populations that are hard to engage.
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Human subjects research organizations need a thorough, fair, and effective way of handling complaints and concerns about research trial ethical and regulatory violations.
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If your IRB office is well-organized, but IRB member information is dated and difficult to track, then it's time for a simple electronic solution: an IRB member roster.
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With the end of the 2009-2010 flu season, it's easy to get complacent about the threat of pandemic flu. After all, the much-feared H1N1 virus appears to be on the wane in the United States, and total deaths here didn't reach some dire predictions made last summer.
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Improving the participation of minority populations in research has been a holy grail for researchers and IRBs.
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As sweeping as the 906-page health care reform bill is, it will have limited impact on human subjects research protection, experts say.
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A recent analysis of clinical trials showing that gays and lesbians have been excluded from certain types of studies is causing reverberations within the research community and beyond.
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Improved treatments for cancer will be delayed and patient lives will be lost unnecessarily unless the efficiency and effectiveness of the clinical trials system improves, a new report from the Institute of Medicine (IOM) concludes.