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The federal regulations leave the job of interpreting "minimal risk" up to IRBs, which can lead to challenges for ethics boards and investigators.
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Very few informed consent policies are extensive enough to convince one IRB director that the protections are extended to everyone who might be asked to participate in a study.
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For years, IRBs have been urged to improve the diversity of their memberships by adding unaffiliated and nonscientist members; the theory being that lay members bring a greater emphasis on the subject's perspective, and can more easily ensure that subjects understand informed consent.
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While a devastating Category 5 hurricane may not be a realistic threat to your IRB's operations, there are still a number of disaster scenarios that could cause evacuations and region-wide disruptions in communications everything from earthquakes and flooding to potential Sept. 11-style terrorist attacks.
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For many IRB offices, it's difficult to find time to handle the daily ethics review work, and so revising policies and implementing new policies can be a difficult challenge.
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Two years after Hurricane Katrina ravaged the Gulf Coast and caused a mass evacuation of New Orleans, research institutions in the city are still recovering.
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Primary care practice-based research networks (PBRNs) bring together physicians and clinicians in practices across the country to research how patients are treated in a primary care setting.
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Anew study adds to the growing body of evidence that surveying people about past trauma doesn't put them at increased risk for harm.
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For IRB offices to run smoothly, employees need to work well together and count on each other when the work overflows.
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When IRB members weigh risks and benefits of an oncology clinical trial, they need to put risks and benefits in perspective for this particular population, or else they'll err by being too cautious, an expert suggests.