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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.
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Procedures:
While the subject is still in the scanner:
- The researcher will run the ten-minute pseudo-clinical imaging protocol on the scanner. This protocol takes about ten minutes to run and , which 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 "pseudo-clinical" protocol will be run instead.
The researcher should ensure that the study is anonymous; no identifying information should be included in the MR study metadata. - 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.
As soon as possible after
After the subject leaves the control room
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- The researcher should download and fill out Section 1 of the BIC's Incidental Findings Log using Adobe Acrobat Pro or Adobe Acrobat Reader. VERY IMPORTANT: Do not use a substitute PDF reader (e.g. Apple Preview or Foxit) to fill out the form. Also, do not print out the form, fill it in by hand, and scan it. All BIC computers have Adobe Acrobat Reader installed for your use.The researcher should e-mail the log form with only Section 1 completed to bic-medical@utlists.utexas.edu. Do not CC or BCC anyone else on this e-mail.complete the Incidental Findings Form: https://utexas.qualtrics.com/jfe/form/SV_cN2iwNutib7AOG1.
- The BIC Safety Panel listed below will process the form and coordinate any contact between the subject and Medical Director as necessary. Once all the procedures have been completed, the PI of the study will be notified IF the findings are medically significant.
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