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.
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.
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.
IRBs working with community partners on non-medical studies need fresh tools, such as resourcefulness and imagination, when engaging in training and education.
