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Are research and quality improvement (QI) mutually exclusive, or natural partners? When QI crosses over into research, what ethical issues can arise?
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Commercial tissue repositories looking for sources of human tissue, and hospitals that discard tissue from surgeries daily, could appear to be a match made in heaven.
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When an IRB is confronted with reviewing an unfamiliar commercial collaboration to collect human tissue, it doesn't have to work in a vacuum.
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As studies become geared toward narrow research questions, targeting specific groups, IRB members will have an even more challenging time resolving ethical dilemmas and weighing risks and benefits.
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Media attention on research conflicts of interest has made it imperative that IRBs be aware of a wider variety of potential conflicts of interest than what they may have considered in the past, experts say.
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It's an accepted truism among many in biomedical research: Blacks won't participate at the same rates as other ethnic groups, because of fear of being exploited, thanks to the legacy of the infamous Tuskegee Syphilis Study.
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IRB members and researchers are beginning to hear more about a new model for weighing risks and benefits in human subjects research. Called component analysis, it requires IRBs to weigh individual procedure risks and benefits against themselves.
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It was mostly good news in a long-awaited report from the General Accounting Office (GAO) analyzing costs at ambulatory surgery centers (ASCs).1
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Leaders of the ambulatory surgery community are praising Congress for passing a provision that requires the Centers for Medicare & Medicaid Services (CMS) to develop quality reporting requirements for ambulatory surgery centers and hospital outpatient services.
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According to a newly released report, reimbursement for gastroenterology procedures provided in surgery centers will decrease by as much as 20% in coming years, which will require a significant restructuring of many practices.
