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As concerns grow over the expense and slow progress of classic randomized clinical trials (RCTs), an intriguing alternative is gaining steam adaptive design, in which trials change at various decision points in response to accumulated data.
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Internet research has been an issue for IRBs since its roots in the 1990s, and the challenges ethics boards face in reviewing such studies are in pioneer territory.
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Internet technology and its impact on society have evolved so quickly in recent years that researchers and IRBs lag far behind in their efforts to understand and use this new forum.
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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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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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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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Signs have been pointing toward a renaissance for intrauterine devices (IUDs). Since 2005, IUD use has gone up by 161%, according to SDI Health, a health care analytics firm in Plymouth Meeting, PA.