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In light of so many providers having difficulty meeting the standard of care for medication administration, the Joint Commission on Accreditation of Healthcare Organizations is taking action.
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At an Oklahoma hospital, two children died within a few days of each other after having routine outpatient surgical procedures. One child died from toxic effects of morphine with a probable primary myopathy as a contributing cause, and the other child died from probable codeine and morphine toxicity, along with acute and chronic bronchitis with evolving pneumonia, according to the autopsy reports.
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Many adults do not understand health information. Nearly half of all American adults 90 million have difficulty understanding and using health information, and there is a higher rate of hospitalization and use of emergency services among patients with such limited health literacy, states a new report from the Institute of Medicine (IOM).
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Recent studies in intensive care units1 (ICU) have found that critical care specialists often try to base decisions about withdrawal of advanced life support measures based on their perception of the patients wishes and the likelihood of survival in the ICU. But making accurate decisions about a patients wishes in such situations often requires clinicians to communicate effectively with surrogate decision makers members of the patients family or others empowered to make decisions should the person become incapacitated.
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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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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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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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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.
