Incidental Findings

In accordance with Columbia University's Incidental Findings (IF) Policy, every human scan that includes a structural series must get a radiology read for incidental findings.  Research participants are told:

As part of this study, a structural image of the brain will be collected during the scanning session. This raises the possibility of detecting a brain abnormality or incidental finding (IF), something otherwise not known to the participant.

Participants will be informed of this possibility during the consent process. The vast majority of IFs are not considered to be clinically relevant. In accordance with Columbia University’s IRB policy with respect to planning for and handling incidental findings, we will comply with the following procedure:

MRI scans are often performed for clinical diagnostic purposes, but the scans being done in this study are for research purposes. It is important to note that the type of scans we use may not pick up some abnormalities. During the informed consent procedure, participants will be informed that these scans are not optimized for clinical readings and that abnormalities may not be observed, even if they do exist. However, it is possible that a clinically significant IF would be identifiable in the scans collected, and therefore images will be read by a credentialed radiologist.

The review by the radiologist will occur as soon as possible but no later than two weeks following receipt of the image. All radiologist reports are available for the PI to read.  The report will mention if the radiologist believes that there is an IF of clinical significance.

In the case of an IF with clinical significance, the PI or a delegated person will notify the participant of the finding via a phone call and answer the participant’s questions about the finding.

 

Columbia University MRI Center at the Neurological Institute

The cost of the radiology read is automatically billed in iLab. A PI setting up a new study may refer to the incidental findings workflow document for the complete process of establishing radiologist review of their scans. The researcher (or their designated staff member) logs into the CUIMC Radiology REDCap account to check the findings. (To create a new REDCap account, contact the NI Senior Systems Administrator.) If there is a medically significant incidental finding, the PI determines the finding's level. To determine this, the PI should consult the Incidental Findings Levels document.  Then the PI contacts the participant as per IRB requirements. Contact the NI Director of Imaging Services for additional details.

 

New York State Psychiatric Institute

The first time a participant is scanned as part of a given research study, they receive a radiology read, as long as the scan includes a series that can be read for incidental findings.  If the same participant is rescanned on the same protocol within a year, another radiology read is not necessary unless the researcher's IRB specifies otherwise. The cost of the radiology read is built into the cost of the scan. If there is an incidental finding, the PI contacts the participant as per IRB requirements. Contact the NYSPI MR Program Coordinator for additional details.

 

Zuckerman Mind Brain Behavior Institute

The cost of the radiology read is automatically billed in iLab. A PI setting up a new study may refer to the incidental findings workflow document for the complete process of establishing radiologist review of their scans.  As soon as a scan ends, the Level III scanner will push the structural MR sequences directly from the scanners to the Radiology research PACS (RADIO) for reading by the assigned radiologists. The study's designated staff member creates a new record in REDCap for the radiologist.(To create a new REDCap account, contact the NI Senior Systems Administrator.) The PI or designated staff member logs into the CUIMC Radiology REDCap account to check the findings

If there is a medically significant incidental finding, the PI determines the finding's level by consulting the Incidental Findings Levels document.  Then the PI contacts one of the contracted MDs to notify the participant and provide advice for the next steps.  (Alternately, the PI may call the participant themselves.)  The PI will provide the participant's contact info and the radiology report to the MD.  The MD will contact the participant as per IRB requirements.

Refer to the step-by-step checklist as a guide.

Urgent incidental findings require an accelerated process for the radiologists and an accelerated process for the primary investigators.

Contact the MR Research Administrator for additional details.

 

School of Engineering and Applied Sciences (SEAS)

TBD


Nathan Kline Institute 

TBD