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Routine fMRI Study Guidelines
The IRB-HSBS, IRBMED, and the U-M fMRI Laboratory have formalized a process in which all standard functional MRI (fMRI) studies conducted by eligible investigators from units typically reviewed by IRB-HSBS are covered under a single, approved master protocol (HUM00093760, Routine Functional Magnetic Resonance Imaging of the Brain). Studies utilizing the approved fMRI scanning procedures outlined in the master protocol, therefore, only require IRB approval for the behavioral component of the study (e.g., task, stimuli, response). That review is conducted by the IRB-HSBS.
Routine fMRI Study Criteria
In order for an fMRI study to be eligible for IRB-HSBS review, the following criteria must be satisfied:
- The Principal Investigator (PI) must be associated with a unit that is subject to IRB-HSBS jurisdiction (i.e., not Medical School or Health System). Undergraduates may not serve as the PI on an fMRI study.
- Participants may be healthy children between the ages of 10-17 or healthy adults age 18 or older.
- The project must be limited to the use of the routine scanning procedures approved in the master protocol. No other scanning protocols may be used.
- No contrast agents (e.g., gadolinium) may be used.
- The MRI pulse sequence will not use gradients that exceed 120 mT/m/s or RF pulses that exceed 1 Watt/kg.
- Other limitations include:
- The study may not involve any drugs or medical inventions.
- The specific-study participant sample may not target Michigan Medicine patients.
- Michigan Medicine patient medical records may not be used in the study.
- The study may not utilize transcranial image stimulation (TMS) or other external methods of disrupting brain function.
- The study may not involve the use of unique or unusual equipment not already in use in the U-M fMRI Laboratory.
Any fMRI projects that do not meet the above criteria must be reviewed by the IRBMED for a determination. This includes any use of an fMRI facility other than the U-M fMRI Laboratory.
Informed Consent Criteria
Participants in these studies must be provided with both the:
- IRBMED master protocol fMRI informed consent that describes the fMRI scanning procedures, risks, and the image retention process; and
- IRB-HSBS consent that describes the other study-specific procedures and risks for the behavioral component of the study.
Preparing the IRB Application
Investigators submitting an IRB application for a study that utilizes the routine fMRI scanning procedures outlined in the master protocol must consider the following:
- The focus of the IRB application should be on the behavioral component of the research.
- The informed consent materials must include both:
- The IRB-HSBS Routine fMRI consent and/or assent document
- The IRBMED master protocol fMRI consent and/or assent document.
- Specific information should be included in the IRB application. See IRB Application Guidelines for Routine Functional MRI (fMRI) Studies for details.
Incident Reporting - Adverse Events/ORIOs/Unanticipated Problems
Investigators must report any adverse events and ORIOs (Other Reportable Information or Occurrences), such as protocol deviations or accidents/incidents to the IRB-HSBS in accordance with standard incident reporting requirements.
Incidents related to the fMRI process, such as mechanical issues with the scanner or deviations from the approved scanning protocol must be reported to the IRBMED via the master protocol (HUM00093760).
fMRI scans used for research purposes are different from clincial MRI scans and are not intended to be used to detect brain abnormalities. If a researcher or fMRI technician incidentally detects an apparent abnormality (e.g., cyst or tumor) in a research scan:
- Follow both the Master Protocol's general process for reporting incidental findings and the IRB-HSBS protocol, which includes the study-specifc plan for handling incidental findings.
- Inform the study PI (or faculty advisor, as applicable) immediately of any abnormal finding.
- The PI is responsible for informing the participant via phone or in a face-to-face meeting to recommend that they follow up with their personal physician and to make arrangements, with the participant's permission, to provide a summary of the abnormal finding with the participant's personal physician.
An adverse event report of the incidental finding should be submitted to the IRB-HSBS.
Participants are provided with contact information for both IRB-HSBS and IRBMED in the consent materials. ORIOs reporting subject complaints should be submitted to IRB-HSBS unless the deal specifically with the fMRI scanning component of the research, which are reported to IRBMED via the master protocol.