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The IRB at East Carolina University of Greenville, NC, was able to satisfy investigators' complaints and improve response times, partly through an overhaul of its policies and procedures.
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As many IRBs rethink their organizational structure to provide for more efficient review, some decide the time is right to create a second IRB and divide their studies into different areas of expertise.
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Many IRBs rethink their organizational structure to provide for more efficient review; some decide the time is right to create a second IRB and divide their studies into different areas of expertise.
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The Office for Human Research Protections (OHRP) of Rockville, MD, published, on Jan. 18, 2007, its final version of new guidelines on reporting unanticipated problems and adverse events.
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Weighing risks and benefits in human subjects research can be an objective, clinical process, unless the person who is measuring is also a study participant whose life is at stake.
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IRB offices require skilled, dedicated, hard-working staff, and it's not always easy to find the right people for the available jobs.
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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.
