Purpose
This page details the procedures to be followed when incidental findings are discovered in a human research scan.
Introduction
Occasionally, previously-unknown abnormalities are noted in MRI scans of unsuspecting research subjects that are otherwise normal. When this happens, the level 2 researcher on duty shall strictly follow these procedures
Procedures
- The researcher will run the pseudo-clinical imaging protocol on the scanner. This protocol takes about ten minutes to run, and is designed to simulate a clinical study for the identification of most abnormalities. If there is insufficient time remaining in the reserved experiment time to complete the study and run the extra protocol, the study shall be immediately terminated, and the extra protocol will be run. The researcher should ensure that the study is anonymous; no identifying information should be included in the MR study meta data.
- At the conclusion of the study, the researchers must not indicate any suspicion of an adverse finding. The study should end as usual, and the researcher should confirm the subject’s contact information before being permitted to leave. If the subject specifically asks if the researcher observed anything out of the ordinary, the researcher should inform the subject that their images will be read by a qualified radiologist, and if anything is noted, they will be contacted. If the researcher cannot in good faith permit the subject to leave the IRC for fear of their safety or the safety of others due to the obvious severity of the abnormality, then the Director, Medical Director, or Facilities Manager must be contacted immediately to assume responsibility of the situation.
- As soon as possible after the subject leaves the control room, the researcher should upload (or “push” in the PACS terminology) the pseudo-clinical images to the Austin Radiological Association server and contact the Medical Director to alert him/her of the situation. The Medical Director will then make arrangements for the images to be read by a board-certified and licensed radiologist. The researcher will also alert the Director or the Facilities Manager.
If, after viewing the relevant images, the radiologist determines that an abnormality does indeed exist, s/he will prepare a report of the preliminary findings and send it to the researcher, the principle investigator, and the Director.
- ) If possible, the radiologist will discuss the contents of the report with the researcher or principle investigator. As soon as possible after that discussion, the radiologist will call the subject, and inform him/her of the findings. If possible, the researcher with whom the subject has had personal contact should be included as a conference call. While on the phone, the radiologist will explain that the images obtained are not of clinically-diagnostic quality, so the findings only suggest that a problem may exist and that the subject should follow up with an appropriate physician. The radiologist should offer to make a referral.
- The radiologist’s report with preliminary findings will be mailed with delivery confirmation (registered mail is preferred) to the subject as soon as possible after being notified on the phone.
- Two weeks after disclosing the radiologist’s findings to the research subject, the researcher will follow up with the subject to see if they need help obtaining an appointment with an appropriate physician if s/he has not already done so. If the subject indicates that s/he does need help, the researcher will ask the radiologist for a referral and forward it to the subject as soon as possible.
- Immediately after the two week follow up, the researcher will prepare a report detailing the nature of the finding and the timeline of all relevant events (including all communication with the subject), and submit it to the Director.