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Most principal investigators (PIs) are not very good at conveying complex ideas in simple terms, an IRB and research expert says.
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More than three dozen institutions who participated in a study of IRB response times will be receiving individualized reports that show how their institution stacks up against the rest of the group.
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Despite the value that placebo controls bring to psychiatric research, they are not appropriate for all clinical trials of antidepressants and anti-anxiety medications.
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Another voice has been added t o the chorus of those blaming excessive regulatory oversight for a slowdown in vital research.
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The U.S. Food and Drug Administration requires that new psychiatric drugs be tested against placebo to ensure that they are effective.
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Whenever the research enterprise is pushed into a new direction, some different ethical issues and considerations arise. Experts say this likely will be the case as more research institutions engage in comparative effectiveness research (CER), as well.
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[Editor's note: President Barack Obama and the U.S. Congress have agreed to spend more than $1 billion on comparative effectiveness research (CER), which some critics say will lead to an unethical strategy of the government justifying rationing health care. Others say it will provide needed information to clinicians about which medical treatment works best. But from an IRB perspective, will CER trials pose any new or more serious risks to human subjects? IRB Advisor asks CER experts nationwide to help us answer this question and others about CER in two stories in this month's issue.]
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It was clear to IRB coordinators that something had to be done to improve the length of IRB meetings. Some of the four biomedical IRBs at Northwestern University in Chicago, IL, were fairly fast in reviewing protocols, but others took too long.
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Improving ease of access to potential research data while aggressively protecting identifiable patient information it's a goal that many institutions struggle with.
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Taking steps now to streamline approval processes for fast-moving diseases will better prepare IRBs to handle not just the current H1N1 virus, but future viruses as well, says Raphael Saginur, MD, FRCPC, chief of the infectious disease division and chairman of the research ethics board (REB) at Ottawa Hospital in Ontario.