IRB Advisor – August 1, 2012
August 1, 2012
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OHRP & FDA issue new guidance on transferring approved projects
As the hurricane season picks up and the potential for other types of emergencies continues, a research institution might find it necessary to transfer its IRB-approved research to another institution. Or an IRB simply might need to transfer a single study for a variety of reasons. Federal guidance on how to handle these contingencies now is available. -
Cultural issues should be addressed in IC process
When research involves an international or multicultural population, there can be informed consent issues that no one anticipates not even the best-informed IRB. -
Best Practices: Pre-review process results in faster IRB review process
IRBs could improve and expedite their review process by hiring someone to pre-review submissions, an expert suggests. -
National Children's Study tests shared IRB model
The first babies brought into the National Children's Study while they were still in utero are now about three years old. And they're not all that's grown. -
Quality improvement study hampered by IRB concerns
Pay-for-performance initiatives, which provide bonuses for physicians, hospitals and other providers who meet certain performance standards, are increasingly used by insurers such as Medicare to try to improve quality and efficiency. -
Recordings of IRB meetings show gaps in discussions
There have been many surveys of IRBs and their operations gauging how long protocols take in their journey through review, how much it costs to operate a human subjects protection program, and IRB members' attitudes about various aspects of their work. -
Lower-income patients less likely to be in cancer trials
A survey of nearly 5,500 cancer patients found that those with lower incomes were less likely to be enrolled in clinical trials, and more likely to be concerned about paying for participation in a trial.