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When a judge recently ordered a pharmaceutical company to provide an investigational drug to a teenage boy who had not met the enrollment criteria for a phase II trial, the IRB world took note.
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IRB fees that are not billed or collected may cost an IRB office the staffing and resources it needs to maintain efficiency and quality in reviewing human subjects research. So it's a good idea for research institutions to take a second look at the IRB fee collection process and improve the policies and procedures wherever necessary.
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An IRB expert makes the case that an IRB can improve its quality by working smartly with data safety monitoring boards (DSMBs), rather than sliding into their jurisdiction.
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While tribal and community IRBs can bring a unique perspective to the study of a specific population, all IRBs should consider community concerns in their reviews, says William Freeman, MD, MPH, CIP, human protections administrator at Northwest Indian College in Bellingham, WA.
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Subject recruitment is one of the more ethically troubling issues raised by the recent case in which a judge ordered that a teenager receive an investigational drug from PTC Therapeutics of South Plainfield, NJ.
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Across the country, Native American communities have begun setting up their own research processes in some cases, their own separate IRBs to review research proposals involving these unique populations.
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A Veterans Health Administration hospital in Arkansas is currently being monitored by the VA after an investigation found human subjects protection violations on a number of protocols.
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Because practice-based research networks (PBRNs) conduct research across a web of physicians' offices, making sure the necessary staff are trained in human subjects protection can be a daunting task.