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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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The 2004 fixed performance areas that will be addressed in random unannounced surveys conducted by the Joint Commission on the Accreditation of Health Organizations will be organized by critical focus areas instead of performance categories as in the past.
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Sometimes, despite your best efforts, an accident occurs with new technology and a patient is injured or dies. Surprisingly, one of the most common mistakes that providers make is insufficient investigation or lack of response to an error so that it is repeated, says Bruce C. Hansel, PhD, executive director of forensic services at ECRI.
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The Centers for Medicare & Medicaid Services has announced these rates for ambulatory surgery center groups, effective April 1, 2004.
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IRBs need to be aware that the tools and data collection techniques used in socio-behavioral research may appear riskier than they actually are, and the public benefits may be greater; therefore, its a good idea to refrain from categorically rejecting research that involves unknown factors, suggests John Laub, PhD, a professor of criminology and criminal justice at the University of Maryland in College Park.
