Governance & Standard Operating Procedure

Section 1: MRIF Governance

The Florida State University Magnetic Resonance Imaging Facility (MRIF) has three established committees for operational oversight and policy review as well as two key personnel with management responsibilities.

The Scientific Director reviews proposals to establish whether the proposed research is feasible, has fundamental scientific merit and is consistent with the mission of the MRIF. The Scientific Director makes recommendations to the Oversight Committee regarding equipment and policy changes.

It is up to each researcher to work with an MRI Physicist to establish, test and optimize safe MRI sequences.

The MRI Technologist is responsible for the day-to-day operations of the MRIF.

Oversight Committee

The MRIF Oversight Committee is composed of representatives from the Office of the Vice President for Research and the Office of the Provost and Executive Vice President for Academic Affairs, the College of Arts & Sciences and the College of Medicine and the Scientific Director of the FSU MRIF. The Representative of the Office of the Vice President for Research shall serve as the Chair of the Oversight Committee.

The Oversight Committee provides strategic guidance and makes decisions on all policy matters related to the MRIF including those related to operations, financial planning and staffing. The Oversight Committee meets at least twice per year to hear a report from the MRIF Scientific Director regarding recent usage of the facility and to discuss and to make recommendations regarding any current matters of interest.

The Oversight Committee has overall authority for actions of other MRF Committees through approvals and directives. Decisions of the Oversight Committee occur by a 60% vote of those present at a meeting. Members can vote by prearranged proxy. Some decisions can occur via E-mail polling. The Oversight Committee has a quorum of 50% attendance. Policy decisions by the Oversight Committee do not supersede those instituted by the University.

Users' Committee

The Users’ Committee consists of Principal Investigators (PI) / Project Directors (PD) who are current users of the MRIF, the MRI technologist, and other relevant parties as determined by the Oversight Committee. The Users’ Committee meets periodically to discuss issues and to make recommendations to the Oversight Committee via the Scientific Director or MRI Technologist, as appropriate. To join the user committee, please email mri-facility@fsu.edu with your request.

Safety Committee

The Safety Committee consists of the Scientific Director, associate director, MRI Technologist, Environmental Health and Safety representative, and a consulting radiologist. The Safety Committee will meet annually and review safety policies and procedures to assess all decisions related to MRI safe practices and decision making in the MRIF. The Safety Committee implements, and manages the MRI safety program, safety policies and procedures, including screening, access controls, and staff training.

The Safety Committee will address concerns or violations of the MRIF Standard Operating Procedures with one the following actions, including, but not limited to verbal and written warnings and probationary status or sanctions. The Safety Committee establishes training procedures for MRIF personnel.

The Safety Committee will meet annually and present any policy and procedure violations and actions to the Oversight Committee.

Policy Changes

Proposals to alter or amend standard operating procedure for the MRIF, as detailed in this document, may originate from any interested party including the user community, the various committees described above and the University administration. Proposed policy changes are reviewed by the Scientific Director and the Oversight Committee.

Section 2: Research Protocol Requirements

Principal Investigators/Project Directors (PI/PD) must be FSU faculty members. Researchers from outside the FSU community desiring to establish a project in the facility must contact the Scientific Director for guidance as to the appropriate steps. Project Directors are responsible for IRB submissions, supervision of the research and financial arrangements for use of the facility.

Prospective researchers must create a separate project in the MRIF booking and project management system for each project that they wish to undertake at MRIF. This includes, details of funding sources, business manager, purchase order, IRB approval letter, IRB approved research protocol and IRB approved consent and assent documents. Note that PIs/PDs in the College of Medicine may need to submit the Research Advisory Committee (RAC) prior to IRB submission. Please factor into your approval process the time taken by review by the RAC, if necessary.

Institutional Review Board – The Human Subjects Committee

PIs/PDs must provide written documentation of IRB approval (initial approval and annual renewal) for all projects involving human subjects.

The IRB at FSU is known as the Human Subjects Committee (HSC). The FSU HSC members have the responsibility for reviewing all research involving human subjects conducted by FSU faculty, students, or staff, regardless of the source of funding.

Full committee meetings are held monthly at a time and location that is subject to change from semester to semester. Information regarding the time and place of meetings may be obtained by contacting the HSC Office, and is posted on the website. Protocols that require review at a convened full committee meeting must be received in the FSU HSC office no later than 5:00 PM deadline day which is posted on the HSC website.

MRIF provides sample consent and assent documents on its website. MRIF strongly recommends that PIs/PDs use these as the basis for their own project specific consent and assent documents.

Note: Full committee review process takes approximately six weeks.

Sections 3 – 6: Site access and restrictions, MRIF Personnel classification and training requirements, subject screening and safety requirements, emergency procedures

Policy and procedures regarding governing these aspects of MRIF operation are governed by the MRIF safety manual. A PDF of the document can be found here. A web-based copy can be found here.

Section 7: MRIF Operations

Management of projects undertaken at MRIF is described in detail in the Project Policy manual of MRIF. A PDF of the document can be found here. A web-based copy can be found here.

Subject Confidentiality

To ensure the subject’s identity remain confidential, the subject’s name or date of birth will not be used when registering them in the scanner, but the correct height and weight will be entered.

Incidental Finding Policy

MRI scans are undertaken for research purposes only and not for diagnostic or therapeutic purposes. MRIF does not have medical or radiological staff that interprets MRI scans, thus no information regarding normal or abnormal findings will be routinely provided to research subjects or their physicians. Variations from expected brain morphology can be seen in many research participants undergoing MRI scans. In light of such variations, and given the rapidly increasing number of research MRIs conducted, significant ethical questions about responsibilities and procedures for detecting and disclosing incidental findings have been raised. Variations may or may not have medical implications.

Incidental Finding Screening

Certain scans (see below) from neuroimaging research will be transferred over a secure data line and screened by a consulting radiologist for Incidental Findings (IFs) unless the subject has opted out of this on their consent form. If the subject is planning on having their scan reviewed for incidental findings, they must consent to doing so in the project-specific consent and assent documents, as appropriate. Sample consent and assent documents containing appropriate language are available on the MRIF website. MRIF strongly recommends that PIs/PDs use these as the basis for their own project-specific consent and assent documents. In addition to providing written informed consent and/or assent, subjects must also complete a HIPPA authorization form that is available on the MRIF website. The cost of the screens is included in the facility use charges.

The MRIF contracts with The Mind Research Network (MRN) for screening of all subjects. To this end, subjects electing to partake in the IF program will have their T1 and T2 weighted scan data sent to MRN via encrypted data link. Other scans such as Susceptibility Weighted Images (SWI), Diffusion Weighted Images (DWI), and Fluid-attenuated Inversion Recovery (FLAIR) can also be send to MRN for review, if needed.

The MRN Contracted Radiologists will review images provided to them, and do not have access to additional clinical information. The MRI scans are collected under research protocols and are not obtained for clinical purposes. The research MRI scans are not a substitute for a clinical scan and might not show problems that may be picked up by a clinical scan. If MRNs find an abnormality that requires follow-up, they may also mail a copy of the report to the subject, or contact them (with their permission), to help answer questions.

All MRN radiology reviews are completed within 30 days and are forwarded as a de-identified report directly to the MRI Technologist. All reports are then printed and mailed via US Postal Service to the subject’s mailing address. They are provided with the contact information of the MRI Technologist in case they have questions. Any returned reports will be recorded and the hard copy destroyed.