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The Office for Human Research Protections (OHRP) in Washington, DC, recently published letters that explain the agency's revised stand on the use of central or external IRBs.
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The Office for Human Research Protections (OHRP) in Washington, DC, is indicating to research institutions that the agency favors the use of centralized IRBs for multisite studies.
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When the federal Office of Human Research Protections raised questions about a quality improvement (QI) initiative to reduce catheter infections in Michigan hospitals in 2007, it reignited a debate over the line between QI and human subjects research necessitating IRB review.
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Based on a survey of research participants, the office of research compliance and quality improvement at Cedars-Sinai Medical Center in Los Angeles, CA, has come up with these four key areas to demonstrate informed consent.
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Research institutions increasingly are turning to central IRBs for multisite clinical trials, and this trend probably will accelerate due to recent news that federal regulators are encouraging the change, experts say.
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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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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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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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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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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.