Requirements To Conduct Human Subjects Research At CMRR:

• All studies with human subjects at CMRR require IRB approval.

• Additionally, the following types of studies require approval by the General Clinical Research Center:

  1. Studies involving clinical populations – research subjects who have been selected for their clinical diagnosis.
  2. Invasive studies in healthy volunteers that involve eg. placement of IV lines, blood sampling, drug administration, probe placement in body cavities, etc.

  Please contact Dr. Elizabeth Seaquist (seaqu001@umn.edu) if you are uncertain that your study requires GCRC approval.

• CMRR safety guidelines are to be followed for all research done at CMRR.

• Consent forms for studies with human subjects at CMRR should include the following IRB-approved language:

  “The images or pictures created during this study are for research purposes only and are not intended to provide health care to you. However, if the results from the magnetic resonance imaging show something unusual in the pictures, a Radiologist trained in reading the pictures will look at them. The pictures will not contain any personal information except your age and pertinent medical history collected as part of the research. There will be no charge to you for having the Radiologist look at your pictures. The investigator for this study will contact you if the recommendation is to further investigate the unusual results of the pictures with your own physician. However, further medical follow up is not a part of this study and the study does not have funds set aside. Therefore, if the results do show something unusual, any medical follow up cost will be your responsibility and/or the responsibility of your health insurance carrier.”

  Please include this language in all new IRB applications. If you have a high incidence of abnormalities in images in your study population, you may want to add the language to your previously approved consent forms and notify the IRB of the change with a letter that has the new consent forms attached. If the template language is not suitable for your study (for example, if you have arranged for a Radiologist to review scans, or have an alternate system for reporting findings to subjects), please provide your rationale to the IRB when you submit the consent and IRB application for their approval.

Steps To Manage Abnormal MRI Results Obtained As Part Of Research With Human Subjects:

If the PI and/or delegate suspects unusual imaging results during a research scan and would like the research scan to be evaluated by a radiologist, the following steps are to be taken:

1. Consent Forms approved by the IRB should contain the language above which addresses the process used to inform the human subject of abnormal MRI results and to further investigate the results using a Radiologist specializing in the area of MRI.

2. 3T users: Researchers interested in this service should enter the 3T event # from the scheduling page in the patient ID field when registering their subjects. Project staff will upload the MRI images to a research scan DICOM server and enter case information into the on line research scan reporting system. The 3T event # will be necessary for this process. Pertinent information to be entered may include a description of the protocol, age in years and gender of the research subject and significant medical or personal health history. No protected health information (PHI) should be entered.

   4T and 7T users: Please contact Brian Hanna (bdhanna@cmrr.umn.edu) regarding transfer of images to the Radiology server.

3. The Radiologist will review the uploaded images and make a determination whether further clinical review is needed. This decision will be available to the PI and staff through the on line research scan reporting system. The PI can then inform the research subject about this recommendation and assist the research subject in the appropriate referral, typically to their personal physician.

NOTE: The charge for a Radiologist to review research scans is currently $50 per research subject. This amount may change in the future. Funds should be included in the budgets of grant applications based on estimated number of incidental MR findings in the particular subject population or how many subjects will need to be reviewed. Grants that support currently active projects may not have funds earmarked for this purpose. The principal investigators of such projects should contact Carolee Wieneke (minck001@umn.edu) or 612-626-0476 for assistance.