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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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With the creation of the Clinical and Translational Science Awards (CTSA) program, the goal of involving the community in research has drawn more support and interest.
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The Agency for Healthcare Research and Quality (AHRQ) has issued a notice about its expectations with the completion of grants awarded from the funding provided by the American Reinvestment and Recovery Act (ARRA). Among the key points:
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Despite efforts by IRBs and investigators to improve pediatric assent, a survey of children with cancer who have been enrolled in clinical trials showed they often don't understand that what they're involved in is research and that they wanted more of a say in making the decision to participate.
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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.
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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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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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Improving the participation of minority populations in research has been a holy grail for researchers and IRBs.
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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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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.
