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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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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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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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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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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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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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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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Gaining approvals from 36 IRBs for a multisite, multilingual epidemiologic study of tuberculosis gave Dolly Katz, who serves on the Centers for Disease Control and Prevention's IRB, insight as to what it's like on the other side of the protocol.
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Some larger research institutions in recent years have taken incremental steps to having an electronic IRB submission, review, and documentation process. But transitioning to a paperless process has been more of a challenge for smaller IRBs and institutions.
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No matter what size your IRB is, you can move to an electronic process for IRB submissions, reviews, and management.
