IRB Advisor – September 1, 2009
September 1, 2009
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Is comparative effectiveness research the 'Big Bad Wolf' critics charge?
[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.] -
How will CER impact IRBs? Inquiring minds want to know
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. -
Using placebos in trials of new antidepressants
The U.S. Food and Drug Administration requires that new psychiatric drugs be tested against placebo to ensure that they are effective. -
When to give the green light to placebo controls
Despite the value that placebo controls bring to psychiatric research, they are not appropriate for all clinical trials of antidepressants and anti-anxiety medications. -
Infectious disease group calls for lessening of regulatory burden
Another voice has been added t o the chorus of those blaming excessive regulatory oversight for a slowdown in vital research. -
Study results to help IRBs see what slows studies
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. -
Expert outlines main struggles, solutions to better informed consent
Most principal investigators (PIs) are not very good at conveying complex ideas in simple terms, an IRB and research expert says.