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A web site designed by Boston's Children's Hospital to better educate parents about pediatric research has won the top award for best practice in human subjects protection by the Health Improvement Institute.
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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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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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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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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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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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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.