Policies & Procedures

The Center welcomes all proposals to employ MRI and MRS in human and animal research. While fully developed proposals will be accepted for review, consultation and/or collaboration with MRRC faculty is strongly recommended, particularly for investigators with little or no technical expertise with MR. MRI/MRS experiments are typically quite complex and involve multiple considerations at all levels from design through data processing and analysis. MRRC faculty are available to consult on the design and execution of proposals. Thus, the first step in submission of a proposal should generally be consultation with an MRRC faculty member. The following suggestions will guide you toward the appropriate contact. Faculty may be contacted directly by email or appointments can be requested by contacting Deyanira Mendoza or calling at extension 3390.

The Gruss MRRC provides consultation and collaborative support across a broad range of imaging research areas. Investigators are encouraged to contact the appropriate faculty member based on their research interests.

All studies must be under the supervision and responsibility of a faculty member. Students and postdocs are encouraged to pursue research within the MRRC and may assume major roles in preparing proposals and executing studies. However, all studies must have a faculty PI. Proposals from investigators outside of Einstein may be considered. However, priority is given to the work of Einstein investigators.

The MRI environment poses numerous serious and potentially life threatening hazards. Prior to the initiation of any project, all project personnel, including the PI, must comply with all safety regulations including personal safety screening and completion of formal MR safety training. Access to the MRI facilities is restricted to those individuals who have received safety training. Investigators and students who wish to begin the process of formulating, submitting and initiating a new MRRC protocol should first visit the MRRC Safety page and familiarize themselves with MRRC safety policies and complete online training.

MRRC access will be terminated for any individual violating MRRC use policy, including unauthorized use of MRRC systems, unsafe use of the systems, or permitting unapproved access to the MRRC facility or systems to unauthorized persons.

Rates for use of the MRRC systems are found on the MRRC charge structure page. These charges include expendable resources used during the MR experiment, (including surgical supplies and anesthetics) and use of any support equipment, presently available in the MRRC.

MRRC Time Awards are available on a limited competitive basis for projects designed to generate pilot data that will support proposals for external funding. Any proposal requesting a Time Award should include an MRRC staff collaborator, and solid evidence that an external funding proposal has either been submitted or is being written and has a reasonable chance of success. The MRRC will also consider Time Awards for novel projects, the outcome of which will either substantially improve the MRRC resources available to other investigators, or will yield some other significant benefit. A completion report must be submitted at the end of any Time Award. Time Awards must be completed with one year of the date of initiation.

All proposals must include a brief narrative description of the project, including specific aims and hypotheses as well as experimental design, methods and a subject sample size justification. Sufficient background information must be included to justify the merit and significance of the project. Relevance to the priorities of funding agencies should be addressed. These latter factors are especially important for proposals seeking Time Awards. Any associated grant proposal should be submitted with the application. Nonetheless, the brief narrative proposal described above must be submitted, even in the case of a funded grant proposal.

Fully completed MRRC protocol application forms may be submitted via email to Deyanira Mendoza or in person at the MRRC. The MRRC Protocol Review Committee meets on a monthly basis. Proposals may be submitted prior to obtaining IRB/CTI or IACUC approvals. However, all protocols must obtain the proper authorizations before they will be approved for initiation. Human use protocols must obtain CCI/IRB approval, while animal use protocols must have IACUC approval. Note that CCI/IACUC approval does NOT guarantee that a proposal will be approved for use by the MRRC.

The Protocol Review Committee (PRC) is comprised of MRRC faculty and staff. The committee reviews new research proposals, oversees ongoing projects, facilitates pilot funding opportunities for the use of MRRC facilities, and identifies unmet needs for investigator-initiated studies.

• Review new MRI research proposals for scientific merit.
• Evaluate sample size, resource utilization, resource requirements, and MRI safety.
• Ensure compliance with Public Health Service, IRB, and other human research requirements.
• Approve MRI research proposals before investigators submit applications to the IRB.
• Identify additional software, hardware, and other resources needed for new or ongoing studies.
• Recommend funding requests to the MRRC Director, Department of Radiology, or Einstein administration.
• Review annual progress reports from all active projects to ensure appropriate progress and resource allocation.

The PRC meets monthly. When new projects require resources that are not currently available within the MRRC, the committee assists investigators in identifying appropriate resources or reports those needs to the Executive Committee.

Chairperson: David C. Zhu, PhD
Members: Dr. Jimmy Lee, Dr. Lei Jiang, Dr. MarkWagshul, Dr. Min-hui Cui, Dr. Faye McKenna, Mrs. Mendoza, Ms. Persaud

• Scientific Merit: The PRC does not review for scientific merit, but may require evidence of scientific merit, such as a letter of support from the department chair or funding agency reviews.
• Feasibility: Is the proposal technically feasible within the existing MRRC resources? Are additional resources or technical implementation required and how will they be addressed?
• Sample Size: The PRC will determine the time necessary to complete the project. This may differ from that requested in the proposal.
• Historical MRRC Usage: Is the proposal related or similar to a previously approved protocol? The PRC will request clarification of the relationship between proposals and prior studies and their MR time allocation. This is especially relevant to request for MRRC Time Awards.
• Likelihood of Success: The PRC will assess whether a proposal is reasonably likely to yield a publishable result. The completion of every study must be followed by submission of a manuscript, and the MRRC must receive a copy of this manuscript in a timely fashion. The support of the MRRC faculty and resources must be acknowledged in all papers and conference presentations.
• Safety: The PRC is responsible for assessing the SAFETY of all proposals, whether previously reviewed or not.

To obtain PRC approval for a new study, investigators must submit the following documents:

1. PI contact information
2. Resource utilization page
3. Budget proposal (including requests for MRRC scan time awards)
4. Abstract page
5. Collaborative arrangements (if applicable)
6. MRI/MRS sequence description
7. Scientific proposal (NIH or other grant application is acceptable), including Specific Aims, Background and Significance, Methods, Experimental Design, and Subject Sample Size Justification.

The PRC evaluates the scientific merit of each proposal and recommends the amount of MRI scan time required based on the projected number of study participants. Except for short developmental projects, all studies should be designed to produce publishable results.

Upon completion of the study, investigators are expected to provide the MRRC with a copy of the resulting manuscript. All publications must acknowledge MRRC support, including any MRRC scan time awards received.

The Safety Sub-Committee is responsible for assessing the safety of all proposals, including previously reviewed protocols, and reports its findings to the PRC.

Chairperson: Jimmy S. Lee, M.D., Ph.D.
Members: Dr. David Zhu, Dr. Lei Jiang, Dr. Mark Wagshul, and Mrs. Persaud

Responsibilities

1. Proposal Safety Review
   • Assess subject safety related to RF and gradient power exposure in accordance with RSNA, ISMRM, and FDA guidelines.
   • Evaluate the safety of wires and other peripheral equipment used in MRI studies.
2. General Safety Functions
   • Review MRRC safety policies.
   • Assess MRRC emergency procedures.
   • Review incident reporting procedures involving the IRB and study participants.
   • Provide guidance to the PRC regarding the reporting and management of incidental findings.

Following review, the PRC may approve, conditionally approve, or disapprove each proposal. Approved proposals are forwarded, with the PRC Chairperson's signature, to the Institutional IRB or IACUC Committees and the Executive Committee. Proposals requesting MRRC scan time awards are also presented to the Executive Committee for consideration.

The PRC reviews all approved protocols annually, and may issues requests for updates on project status. Failure to respond to these requests will result in suspension protocol.

After the MRI acquisition protocol has been implemented, the MRRC physicist meets with the PI, research staff, and MRI technologist to review data acquisition procedures, MRI safety requirements, data transfer workflows, and project-specific operational needs. The team develops a standardized operating manual and conducts hands-on training in the MRI suite.

During the first participant scan, the MRRC physicist works directly with the PI's research team to ensure correct protocol implementation and resolve any issues before routine data collection begins.

MRRC physicists continue to provide consultation and technical collaboration throughout the duration of each project.

MRRC scientists offer individualized consultation, small-group training, and formal research collaboration. Investigators without MRI expertise are encouraged to collaborate with MRRC faculty to maximize project success.

Open user meetings are held regularly via Zoom each month. Meetings provide updates on MRRC operations, MRI acquisition and analysis methods, user feedback, and presentations by MRRC scientists and investigators.

MRRC provides training for PhD students, postdoctoral fellows, research assistants, and investigators through formal coursework, workshops, and collaborative research. Current graduate courses include:

• Principles of Magnetic Resonance Imaging
• Biomedical Imaging Analysis Methods
• Survey of Medical Imaging Applications

An additional course, Introduction to MR Neuroimaging, is planned. Postdoctoral fellows and research assistants working with MRRC faculty are also encouraged to attend these courses.