SOP105: Incidental Findings

  1. Summary

    On rare instances, a research Subject may have a MRI scan that the Experimenter judges to be abnormal. This SOP establishes procedures governing such incidental findings.

  2. Scope

    These policies apply to all investigators, research assistants, and MRI operators who use the BIAC research scanners.

  3. Definitions

    • Subject - An individual who is participating in an experimental protocol at BIAC and has not taken the BIAC safety course.

    • Experimenter - The investigator, research assistant, or MRI operator who is responsible for the Subject and conducting the experiment.

  4. Policies and Procedures

    Some research protocols at BIAC, particularly those involving patient populations, include a radiologist as a co-investigator to perform a clinical screen of the MRIs for each Subject. In other protocols that focus upon presumably healthy and neurologically normal individuals, there is no radiologist co-investigator and thus no clinical review of the images. On rare occasions, the Experimenter or MRI Operator may notice an apparent abnormality on an image while scanning that may require a clinical review. These procedures should guide the Experimenter's or MRI Operator's actions in these circumstances when there is no radiologist co-investigator.

    1. The Experimenter or MRI Operator should not bring their concerns to the attention of the Subject at the time of scanning. Only a qualified physician can determine the clinical significance of an apparent MRI abnormality. A Subject may experience emotional distress if told that their scan looked abnormal.

    2. Many apparent abnormalities turn out to be common image artifacts (zippers, ghosts, susceptibility artifacts). If possible, the Experimenter or MRI Operator should immediately consult with a more experienced investigator or BIAC faculty member to determine if the abnormality is a common artifact.

    3. If the abnormality is not an obvious artifact, or if there is no experienced investigator available for an immediate consult, the MRI Operator should acquire an axial T2-weighted series using the stored protocol created by Dr. Jeff Petrella for incidental findings. This T2 series will be submitted for a clinical review by the Duke Neuroradiology staff.

    4. It is likely that the clinical review of the T2 series will not occur until the Subject has been dismissed from the experiment. For this reason, be certain that the Subject has filled out the contact information on the consent form, so that he or she can be contacted later if necessary.

    5. It is the Principal Investigator's responsibility to ensure and document that the appropriate follow-up occurs. The PI must make sure that the T2 series is read by radiology. If the radiology reports indicates that the scan is clinically abnormal, then the PI must document that the Subject was contacted with this information — even if the information is provided to the Subject directly by a radiologist or other qualified physician.

    6. If the scan is read as normal, then no additional Subject contact is warranted.

    7. The Principal Investigator must inform the BIAC director in writing or in email of the incidental finding and its resolution. The IRB may also wish to be informed at the time of the annual renewal.

SOP