IRB Advisor – June 1, 2014
June 1, 2014
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Creative thinking needed when IRBs educate community partners
IRBs working with community partners on non-medical studies need fresh tools, such as resourcefulness and imagination, when engaging in training and education. -
Tips for community partner education
When it comes to training community partners on human research protection ethics, IRBs would do well to create educational content that best suits the needs of those partners, an IRB chair suggests. -
Every improvement helps IRB inefficiencies
Accredited human research protection programs (HRPPs) are required to meet a seemingly simple standard that requires a quality improvement program to be focused on efficiency and compliance. -
Streamline forms with better communication
As IRBs focus more on efficiency and streamlining, the chief concern involves maintaining the necessary elements while discarding or simplifying everything else. This delicate balance is especially true for streamlining informed consent documents. -
Plan ahead for imaging IFs, experts say
Advancements in imaging technology mean a greater chance of detecting incidental findings in imaging research subjects. As IRBs turn their attentions to figuring out how to handle and manage IFs, some may not know where to begin or how to get their plans to the implementation stage. -
Expert advice for seeking emergency use
For some patients, enrolling in a clinical trial is not an option. They may meet exclusion criteria, or the nearest trial center may be geographically inaccessible, despite having a disease or condition that could benefit from investigational treatment. In such cases, the patients physician can request expanded individual patient access from the Food and Drug Administration. In dire situations, the physician can seek emergency use.