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Two years after Hurricane Katrina ravaged the Gulf Coast and caused a mass evacuation of New Orleans, research institutions in the city are still recovering.
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For many IRB offices, it's difficult to find time to handle the daily ethics review work, and so revising policies and implementing new policies can be a difficult challenge.
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While a devastating Category 5 hurricane may not be a realistic threat to your IRB's operations, there are still a number of disaster scenarios that could cause evacuations and region-wide disruptions in communications everything from earthquakes and flooding to potential Sept. 11-style terrorist attacks.
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For years, IRBs have been urged to improve the diversity of their memberships by adding unaffiliated and nonscientist members; the theory being that lay members bring a greater emphasis on the subject's perspective, and can more easily ensure that subjects understand informed consent.
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Very few informed consent policies are extensive enough to convince one IRB director that the protections are extended to everyone who might be asked to participate in a study.
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The federal regulations leave the job of interpreting "minimal risk" up to IRBs, which can lead to challenges for ethics boards and investigators.
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Now that IRBs have both the final guidance on unanticipated problems and adverse events from the Office for Human Research Protections (OHRP) of Rockville, MD, and the draft guidance from the Food and Drug Administration (FDA), their duties in handling these issues should be clear, right?
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In April, 2007, the Food and Drug Administration (FDA) issued its draft "Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting Improving Human Subject Protection."
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When IRB members weigh risks and benefits of an oncology clinical trial, they need to put risks and benefits in perspective for this particular population, or else they'll err by being too cautious, an expert suggests.
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For IRB offices to run smoothly, employees need to work well together and count on each other when the work overflows.
