Facility Policies

The CIS policies and procedures were developed to be consistent with the internationally accepted recommendations from the American College of Radiology. Violations of these policies and procedures will result in a review of the incident or event with the CIS Steering committee, the Principal Investigator, and the responsible individual. Depending on the nature of the violations, the Office of Research Integrity may require an inquiry or investigation. Using MRI systems for research studies requires the adherence to prescribed procedures so that the working environment remains safe. This includes the safe handling of human subjects, personnel, and equipment.

  • The CIS MRI Facility is a research facility, providing no clinical services, and is not part of a covered entity. Thus, while not required to comply with the Health Insurance Portability and Accountability Act (HIPAA), the MRI Facility still safeguards participant privacy. However, some research studies at FIU utilize Protected Health Information (PHI) from covered entities. These studies are conducted in a manner that respects human subjects’ privacy in accordance with the Privacy Rule promulgated under HIPAA and other applicable laws.
  • Structural MRI scans are among the imaging technologies used in research at the CIS. MRI scans undertaken for research purposes are not intended for use as diagnostic or therapeutic purposes. The CIS does not have medical or radiological staff that interprets MRI scans, thus no information regarding normal or abnormal findings will be routinely provided by CIS staff to research subjects or their physicians. There is no national requirement to have every research scan read by an outside radiologist. However, in recognition of the fact that, on occasion, incidental findings may need to be investigated medically, and in a best-faith effort to inform research participants of that possibility, the policy of the CIS is to have all structural scans of research subjects reviewed by a radiologist. If investigators would like to request an exception to this requirement for participants with diagnosed brain damage, this can be requested in the IRB protocol application.
  • All FIU investigators conducting human subjects research who plan to use the CIS MRI Facility must obtain FIU IRB approval (except for cases where an agreement allows for FIU to defer approval to an external IRB). All external non-FIU investigators conducting human subjects (for studies in which FIU is not engaged in conducting the research and FIU is not a source for recruitment) are required to obtain IRB approval from their own institution. More information is outlined here: IRB SOP for MRI Research.
  • If any incidents occur within the MRI Scanner Room, regardless of severity, they must be reported to the MR Physicist as soon as possible. The researcher supervising the experiment and the Level 3 Operator will complete an Incident and Adverse Events Report under the supervision of the MR Physicist. All incidents and adverse events that involve human subject participants must also be reported separately to the IRB per the requirements outlined here: IRB Adverse Event Reporting.
  • No contrast agents will be used in scans conducted at the CIS MRI Facility.
  • Pediatric studies that involve the use of sedation during MRI scans will not be permitted at the CIS MRI Facility.
  • All new equipment used for research MR studies must be tested for MR safety and compatibility BEFORE entering the fringe field (see static magnetic field) by the MR Physicist. MR researchers must never take equipment into the magnet room without prior approval from the CIS.
  • It is the responsibility of every researcher to IMMEDIATELY report any equipment failure to the MR Physicist. This includes broken cables, loose connectors, arcing or sparking of devices, leaking of fluids, and any other malfunction or suspected malfunction.
  • No eating, drinking, or storage of food and beverages is permitted in Zone 4 (the MRI scanner room and equipment room).
  • Participants shall be instructed to wait in the lobby/waiting room of the CIS until they can be escorted to the MRI Suite. A researcher will meet the participant in the lobby to escort them through the building.
  • Participants should be instructed to arrive with sufficient time to allow for the completion of safety screening and to prepare for the scan. The amount of time required may depend upon the conditions of each particular study. If the participant is running late, consideration must be made for any studies scheduled after that participant. Even if it started late, the session must end on time. In some cases, the participant may need to be rescheduled. Researchers are expected to arrive at the facility at least 30 minutes prior to the scheduled arrival time of a given participant; repeated tardiness may result in a loss of privileges at the CIS.