Standard Human MRI Scanning Procedures

Please note the following standard operating procedures when scanning any human research participant:.

1. You must not schedule use of an MRI system until you have received all relevant approvals. This includes:
   • Approval by the CABI Protocol Review Committee;
   • Approval by the NKI Institutional Review Board;
   • Approval by both the NKI Director/Designee and the Director of Clinical Research Administration, Research Foundation for Mental Hygiene. Both these signatures, together with others from the NKI IRB and Rockland Psychiatric Center, if relevant, are provided on the Protocol Disposition Form (PDF).

   Because the PDF documents the final step in the approval process for human subjects, the PDF must be present on our files before any protocol can begin. No informed consent can be obtained under the auspices of your protocol until we have received the appropriate PDF. If you have questions about whether the necessary documents have been received for your protocol, please contact Elyse Ackerman (ackerman@nki.rfmh.org) or Dr. David Guilfoyl (guilfoyl@nki.rfmh.org).

2. Assuming you have received all necessary approvals, and have scheduled time to use one of the MRI scanners, you are permitted only to run those procedures that have been approved in the context of your protocol. If you wish to change the procedures from those that are specifically indicated in your original protocol, you must submit an Addendum or Amendment to the existing protocol. This must be submitted to both PRC and IRB, and again you cannot implement the new or revised procedures until you receive a new PDF specific for that amendment. In your submissions, it is important to provide a justification for the change or addition of procedures, specifically considering how these may change the risk/benefit ratio of your research, and also that you update any other forms that may be affected (e.g., the Resource Utilization Form must be altered if there is a change in the sequences or number of subjects you wish to run; and the statements of Relevance and Collaboration may be changed as well).

3. Please note that we are required to monitor and maintain copies of all forms used with human subjects studied in our systems (see specific forms that need to be completed below). These need not be the originals (which investigators may wish to keep for their own files), copies are adequate. The forms for each protocol are audited periodically. Any discrepancies or omissions will be cause for immediate suspension of scheduling privileges and any other protocol-related activities on the CABI.

SMIS 3.0 T MRI System

Minimum 3 (three) forms are required when doing a scan on the 3 T MRI.

1. MRI Consent Form: This must be the correct IRB-approved version of the informed consent form for the protocol in question. It must be completed in full (including signatures of participant, witness, and participant's initials on each page).
2. MRI Screening Form: A revised form is now available, which requires the name of the screener and a signature of the person being screened. This form can be re-used for the next visit with a new date added on to it, for those subject who participate in repeated studies.
3. Exit Interview Form: Specially designed for the 3T MRI, to be filled by the subject about any effects felt in the scanner. A new form is to be filled after every scan, with or without any side effects felt or observed.

All these forms are kept in a locked file cabinet in the CABI reception office. The run sheet is filed in a folder prepared for each subject in each protocol & filed under the date scanned. For participants in repeated studies within a single protocol, new forms are filed chronologically as per the date they are scanned..

Note: All human data acquired on the scanner will be archived on the CABI image archival system moved via ftp to users directories under AFS archival systems & or burnt on CD-R and DVD-R.

Siemens 1.5 T MRI System

1. There are Consent Forms, the criteria of which are the same as for the 3T MRI. These are filed precisely as those for the 3T system.
2. The Screening Forms are also the same (and filed in the same way) as on the 3T MRI.
3. There is no Exit Interview Form for the 1.5T MRI.
4. All human data acquired on the scanner will be archived on the CABI image archival system and moved via ftp to users directories under AFS archival systems & or burnt on CD-R and DVD-R.

Keeping Hygienic Conditions

For hygienic purposes, there are Bouffant Caps to cover the foam pads and shoe covers for the pads on the side of the head and ears. Ziploc sterile bags& cups are available for dentures with labels on the bag. These are all disposable! Clean sheets and blankets are suggested to use for all and are re-cycled. Please clean the head coil with napkins/towels wetted in warm water after every completed session to keep infections at bay. Put everything back as it was, after your scans are done. Do not try and disconnect any cables and wires you do not know of. Ask for help! The person being scanned has a locker for his or her belongings in the dressing area, the keys to which are located in the 1.5 T and the 3.0 T MRI rooms. Please delete your data when done with ftp & archiving, etc.

Downloadable forms

The downloadable forms have been added to those in the CABI Collaborative Research page.

Should you have any questions, please contact Mr. Rajen Sangoi, the CABI Safety Officer and Chief MRI Technologist / Coordinator.

This page was last updated on 4/13/2008.