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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 Level 2 researcher on duty shall strictly follow these procedures.

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Procedures:

While the subject is still in the scanner:

1. 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.
   
   
2. 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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1. 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.

2. 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.

3. The BIC Safety Panel listed below will process the form and complete the Incidental Findings Form: https://utexas.qualtrics.com/jfe/form/SV_cN2iwNutib7AOG1.  
   
   
4. The BIC Safety Panel 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.  The outcome of the Incidental Findings process is considered confidential information and will not be disclosed to the research team. At the request of the PI, the BIC Safety Panel may disclose whether the finding was normal biological variation or if a clinical follow-up was warranted. Since research images are inherently non-diagnostic, a clinical follow-up does not indicate that the incidental finding was medically significant and may occur if images of higher quality are required.

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Implementation and Update of Active IRB Protocols

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BIC Safety Panel

Doug Befroy, BIC Facilities Director
J. Neal RutledgeChang Ho, BIC Medical Director
Don Nolting, BIC Facilities Manager
Julie DiCarlo, BIC MRI Staff Scientist

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