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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'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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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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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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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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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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One of the bigger headaches for IRBs is having to sift through hundreds or thousands of unanticipated problems submissions when most of these should never have been reported.
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One of the drawbacks for research conducted in this age of checklists and strong regulatory oversight is that IRBs and research institutions do what they're required to do and sometimes neglect to address the bigger picture, an ethics expert says.
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The two-part process of electronic submission of unanticipated problems at Washington University School of Medicine in St. Louis, MO, requires investigators and clinical trial staff to enter information about the events after passing the chief screening criteria, and then it requires a reviewer to look at what has been submitted.
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Students who did practice sessions with a virtual reality "human subject" learned better informed consent skills than did those who only studied consent rules from written material, according to a recent study.