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With federal regulators shifting toward policies that would facilitate more central IRBs for multisite research, human subjects research protection offices need to take note and develop guidelines and tools for handling shared IRB responsibilities in multisite trials, an expert says.
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There have been many surveys of IRBs and their operations gauging how long protocols take in their journey through review, how much it costs to operate a human subjects protection program, and IRB members' attitudes about various aspects of their work.
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The first babies brought into the National Children's Study while they were still in utero are now about three years old. And they're not all that's grown.
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Pay-for-performance initiatives, which provide bonuses for physicians, hospitals and other providers who meet certain performance standards, are increasingly used by insurers such as Medicare to try to improve quality and efficiency.
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When research involves an international or multicultural population, there can be informed consent issues that no one anticipates not even the best-informed IRB.
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As the hurricane season picks up and the potential for other types of emergencies continues, a research institution might find it necessary to transfer its IRB-approved research to another institution. Or an IRB simply might need to transfer a single study for a variety of reasons. Federal guidance on how to handle these contingencies now is available.
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IRBs could improve and expedite their review process by hiring someone to pre-review submissions, an expert suggests.
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A survey of nearly 5,500 cancer patients found that those with lower incomes were less likely to be enrolled in clinical trials, and more likely to be concerned about paying for participation in a trial.
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IRB directors seeking to start their own local IRB network can make this happen with just a little up-front effort, experts say.
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IRB administrators who use the Harvard Catalyst's ceded review system say it performs as promised providing a more efficient way for institutions that collaborate frequently to handle multisite studies.
