Incidental Findings Policy

The Behavioral Sciences Imaging Center (BSIC) is state-of-the-art, research-focused center to support the UTH mission for advancing imaging and neuromodulation to understand human brain and body in health and illness. Most of the research performed at BSIC uses imaging protocols that are based on novel research sequences that are not FDA approved for the purposes of diagnosis or treatment of any illnesses. These sequences are provided for research use only and are not meant for making clinical diagnosis or decisions. Therefore, the imaging data will not be sent for routine clinical reading. It is the responsibility of investigative teams to convey the limitations of data collected using research imaging protocols to the participants in IRB approved consent documents. We provide examples of such languages used in UTH-approved IRB protocols. Each participant should be informed and consented accordingly prior to imaging. Investigators have the option to use, modify, or not use these languages. Investigative teams are expected to have a screening and evaluation procedure in place to evaluate participants for any neurological abnormalities as part of the consenting process.

Examples of IRB text:

Example I

“Incidental Findings

The investigators for this project are not trained to perform radiological diagnosis, and the MRI scans performed in this study are not designed to find abnormalities and are being conducted only for research purposes. If the investigators notice a finding on an MRI scan that seems abnormal, the scan will be shared with a licensed radiologist or a neurological expert for further evaluation. If the expert thinks that further investigation of the finding is called for, you will be contacted about the finding and next steps. You will also receive a copy of the MRI report for your records. The decision as to whether to proceed with further examination or treatment lies solely with you and your physician. The images collected in this study are not meant or approved for diagnosis or treatment of any disorder and do not comprise a clinical MRI study.”

Example II

“The tests here are for research purposes only and are not the type used to look for problems like a tumor or to make a diagnosis. It will not be routinely reviewed for these sorts of problems. However, sometimes MRI and other tests may show what could be an abnormal finding. Should this occur, we may seek a specialized physician’s opinion, or you will be referred to the proper expert(s).”

If any staff and faculty notice incidental findings during or after a scan, the PI must be informed as soon as possible, and the facility staff will not inform the research subject unless instructed by the PI to do so. If any staff and faculty in viewing or processing their research imaging data collected at BSIC identifies any potentially clinically meaningful findings at any time, BSIC can assist transfer of the images to a neuroradiologist or a neurological expert that the Center uses, or the PI has designated for evaluation. The PI may be responsible for the charge associated with the expert read. BSIC staff can assist with the transfer of the images to the expert and obtain the MRI read report for the PI. The PI is responsible for communicating with the participants about the findings and other necessary or recommended follow-ups.

Investigative teams may opt to include FDA-approved sequences into their imaging protocols to collect data that is approved for diagnostic purposes. BSIC personnel can assist in implementing such protocols. It is the responsibility of the investigative team to work BSIC personnel to design such as protocol and establish and test transfer of the data for clinical read and incorporate it into the standard operating procedures, prior to the start of the protocol. In such cases, we recommend that the consent form includes languages that clearly state that and inform the participant of the pros and cons of having their images read for diagnostic purposes and receiving incidental findings see Example III.

Example III

This research study will collect brain MRI scans to characterize the change in brain structure and function for diagnosis and/or in response to treatment. These scans are obtained for research; however, all scans will undergo a clinical review by a licensed radiologist as part of the study protocol.  During this evaluation, we may identify incidental findings that are unrelated to this study but may have health implications for you. This may include unexpected abnormalities such as masses, lesions, aneurysm, hydrocephalus and others.  Dr. _________ will communicate these results to you.  You may select whether you wish to receive:

• All radiologist-identified findings
• Only actionable or urgent findings
• No findings unless urgent/critical

Participants can change their preference at any time.