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Working in the 3T-fMRI Facility, University Heights Flow of Work and Approvals Process (established Dec, 13, 2001) The following processes will be used to conduct studies or clinical evaluations in the 3T MRI facility. Click here for IRB Forms and guidelines for gaining research access to the center All Work. Two accurate logs will be maintained in the facility to account for every person - without exception, including self examinations by P.I.'s - who undergoes an MRI scan. One log will be specific to clinical visits and will include the patient's name, the technician in charge, and the name of the referring physician. The second log will record all research scans with the subject's name, the title of the research project and P.I., including the IRB approval reference number. Periodically both logs will be distributed to the Management Group. Patient names will be removed before distribution in accord with HIPAA regulations. Clinical Work. Clinical scans must be scheduled through the UMDNJ Radiology Department. There must be adequate justification for use of the 3T magnet with clear advantages over the 1.5 T clinical machines available at the DOC or UH locations. Clinical work will be scheduled to the maximum extent possible in back-to-back sessions to allow for best use of technician time, and maximum possible patient privacy and comfort. Clinical work will be scheduled in advance. Initially, mornings will be set aside for this work. Research Scans. Research scans, following approval by the IRB, should be scheduled though a Research Committee, consisting of Drs. Hanson and Biswal, and Mr. Tunnel. Research studies proposed for the 3T MRI facility should have the approval of the appropriate chairs within the institution or institutions of origin before submission to the IRB. Facility Modifications. All requests to modify the 3T MRI facility, including, but not limited to physical modifications (wall penetrations and the like) and magnet or coil modifications, must be approved by the Research Committee and reported to the Management Committee. Institutional Review Board(IRB) Issues. UMDNJ and Rutgers University have an IRB authorization agreement. The purpose of the IRB authorization agreement is to facilitate review of IRB protocols conducted by Rutgers and UMDNJ personnel specific to the 3T Advanced Imaging Center, a Rutgers/UMDNJ facility developed under a joint venture agreement and located at 30 Bergen St., Newark, NJ. This UMDNJ/Rutgers agreement will authorize the UMDNJ Newark Campus IRB to provide IRB review, approval and oversight. Rutgers may rely on the UMDNJ-Newark Campus IRB to provide review, approval, and continuing oversight provided under the UMDNJ Assurance for collaborative protocols conducted on the UMDNJ Newark Campus by Rutgers and UMDNJ personnel at the 3T fMRI facility of the University Heights Advanced Imaging Center. The review, approval, and continuing oversight performed by the IRB shall satisfy the requirement of the U.S. Department of Health and Human Services (DHHS) regulations for the protection of human subjects at 45 CFR 46; and the U.S. Food and Drug Administration (FDA) regulations at 21 CFR 50, 56, 312, 812 and all other appropriate regulatory requirements, as well as the requirements of UMDNJ's approved Assurance. Relevant minutes of IRB meetings, approval notices, compliance actions, adverse event reports, and all other related paperwork shall be made available to Rutgers State University for all collaborative protocols. Rutgers, at its discretion, may occupy a seat as a voting member on the UMDNJ-Newark Campus IRB. The Rutgers member, or designated alternate, will be provided with advance notice of meetings that review said protocols related to the 3T Advanced Imaging Center. Rutgers remains responsible for ensuring compliance with the IRB's determinations and with the terms of Rutgers OHRP-approved Assurance. Rutgers agrees to allow the UMDNJ-Newark Campus IRB to audit any and all protocols conducted by Rutgers personnel under this Agreement. The University Heights 3T fMRI Managment Group From UMDNJ Bill Stephenson, Vice President of Research Stephen Baker, MD, Chair, Radiology Department From Rutgers-Newark Harvey Feder, Associate Provost for Academic Affairs Gene Vincenti, Associate Provost for Budget & Campus Development Stephen J. Hanson, Chair, Department of Psychology IRB Forms and guidelines for gaining research access to the center The University Heights Center for Advanced Imaging A joint venture of UMDNJ New Jersey Medical School and Rutgers-Newark  
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