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Human subjects research protection experts agree that IRBs are overburdened and that something should be done to improve the regulations and rules governing their work. However, there is less agreement on how this could be accomplished. IRB Advisor asked IRB and research professionals to discuss how IRB regulations or the interpretation of them might be improved.
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For the University of Pennsylvania School of Medicine in Philadelphia, there was no question that the only acceptable solution to the problems in human subjects research was to establish a comprehensive program that included all areas, including investigators, IRBs, and the institutions leadership.
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A 1999 National Institutes of Health-sponsored project to evaluate the results of a drug-testing program in Oregon public high schools was ultimately suspended after the federal Office for Human Research Protections (OHRP) decided that the goals of the research protocol appeared to have become intertwined with the drug-testing policy it was intended to study.
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Its a rare occurrence, but each year some institutions are subjected to a for-cause audit by the Office for Human Research Protections (OHRP). Such audits often turn up documentation problems and review process problems with the IRB, but occasionally they also highlight very serious problems relating to the clinical trials management, such as failure to provide adequate informed consent or failure to seek an IRB review, according to OHRP officials.
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Economy class syndrome (ECS) refers to venous thromboembolic episodes among airline passengers who have remained immobile for long periods in cramped seating that impairs their circulation. Economy class passengers with little leg space are more likely to suffer such events than passengers in roomy first-class seats.
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In this epidemiologic analysis of 22,312 individuals living in Norway, a total of 87 reported having developed multiple sclerosis. The risk of developing multiple sclerosis was significantly higher among smokers than among never-smokers.
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In an entirely novel observation, Walz and associates describe a cellular prion protein variant associated with hippocampal sclerosis that seems to be partially predictive of seizure-free outcome in patients undergoing surgery for medically refractory mesial temporal lobe epilepsy.
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What characteristics of a neuropathy make Sjögren syndrome the likely diagnosis?
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Discharge planners and case managers certainly cannot accept cash payments from providers in exchange for referrals of patients. But what about non-cash items that have a relatively low value and that providers are not obligated to provide to case managers? Can case managers accept such items?
