In Neuroimaging Trials, How Do You Handle Controls Who Are Found to Have Incidentally Discovered Abnormalities?


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Abstract

Q:You have recruited healthy control subjects and patients with Alzheimer disease for an fMRI study monitoring disease progression. But when you analyze the brain fMRI studies, you find unexpected imaging abnormalities in some of your controls. It's not clear if these abnormalities are clinically significant because the scans contain only selected images necessary for the research protocol. Do you tell the research control subjects about these incidentally discovered findings? If so, what exactly should you tell them and how should you proceed?

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