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Incidental Findings

    

The policy for incidental findings on MRI research images

It must be made clear to the subject via the consent form and verbal reinforcement that the images will not be formally reviewed. The purpose of their participation in the research study should not be to obtain medical information. However, if a researcher or their students or staff should notice something that is potentially abnormal this information should be forwarded to the collaborating MD and to a CTI Tech. The Tech will log the incident in the event log book, which will show the date observed, the study name, the radiologist reviewing the images, and the final outcome and recommendations. The subject should not be informed about the abnormality at the time of scanning in order to eliminate any risk of anxiety for no reason. The CTI staff will have a radiologist review the research images. Information about the subject may be required in order for the radiologist to make an informal reading. This exchange will be facilitated by the Techs. If the suspected abnormality is normal there is nothing else to do. If the finding requires a follow-up, the findings will be reported back to the PI. The PI should either contact the subject or the subject’s physician depending on what the subject desires. An incidental letter will be mailed to the subject. In cases where the study has a process for incidental findings the study will send out the letter according to their study protocol.

Flow chart of events:

  1. Images are taken
  2. The researcher or their staff, Tech or other Radiology personnel may notice a potential abnormality without disclosing to the subject.
  3. Tech records the incident in the event log book.
  4. The de-identified images are forwarded to the MD on the project or to an appropriate Radiologist for review.
  5. A determination is made by the Radiologist, either medically insignificant or medically significant.
  1. If the finding is medically significant an incidental letter will be mailed to the subject.

Responsible Party: Jeremy Collins, MD Assistant Professor of Radiology