SOP107: Running Subjects

Summary

This document establishes procedures for the proper running of research Subjects at the BIAC MRI suites.

Scope

These policies apply to all investigators, research assistants, and MRI operators who use the BIAC research scanners.

Definitions

• Subject - An individual who is participating in an experimental protocol at BIAC and has not taken the BIAC safety course.

• Experimenter - The investigator, research assistant, or MRI operator who is responsible for the subject and conducting the experiment.

• Magnet Room - The room within the MRI suite that contains the MRI scanner. It is accessed from within the console room through a doorway that is controlled by an electronic lock.

Policies and Procedures

1. Escorting the subject, safety screening, and consent:

   1. The Experimenter should contact the subject prior to the day of scanning and perform a brief phone screen to make sure that the subject does not have an obvious contraindication to scanning. Please refer to the procedures governing phone screening in SOP108: Screening Subjects.

   2. The Experimenter will meet the subject at the reception desk to the MRI wing. The Experimenter should leave the subject's name with the receptionist and asked to be called when the subject arrives at the desk.

   3. The Experimenter will ask the subject if s/he has a pacemaker or other implanted medical device. If the answer is "yes" or ambiguous, the subject must be refused admittance to the MRI wing. Proceed to the following steps only if the answer was unequivocally "no."

   4. The Experimenter will ask the subject if they wish to leave valuables in the lockers at the reception area. The Experimenter will caution the subject that magnet fields may erase credit cards.

   5. The Experimenter will ask the subject if they wish to use the lavatory prior to entering the MRI suite.

   6. The Experimenter will escort the subject to the MRI suite, and make sure that the door to the MRI suite is closed following their entry.

   7. The Experimenter will conduct a screening interview with the subject. The subject must fill out an approved screening form. The form must be signed and dated by the subject and Experimenter. Please refer to SOP108: Screening Subjects.

   8. The Experimenter must consent the subject for the particular protocol. A subject cannot be run in any MRI protocol without signing and dating an IRB approved consent form. Verify that pages are initialed and that the final page is signed. The Experimenter must sign the consent form to indicate that this review has taken place. If signed consent is not obtained, the subject must be dismissed at this time. Please refer to SOP100: Consenting Subjects.

2. Preparation for entry, and entry into the Magnet Room:

   1. The Experimenter should choose appropriate lens to fit into the experimental goggles for subjects who require correction for their vision.

   2. The Experimenter must make sure that the subject has appropriate ear protection (ear plugs) and instruct them on their proper insertion. The Experimenter should verify that the ear plugs are properly inserted.

   3. The Experimenter must warn the subject that they may feel initially claustrophobic when they first enter the scanner. Subjects should be advised that this feeling usually passes quickly, and that the Experimenter will keep in contact over the intercom to minimize this feeling.

   4. The Experimenter must remove all metal from his or her person prior to entering the Magnet Room. Only Experimenters who have had appropriate safety training can enter the Magnet Room with the subject.

   5. The Experimenter must inform the subject to enter the Magnet Room slowly, and to be sensitive to any tugging feeling that might indicate they have forgotten to remove a metal item from their pockets or elsewhere.

   6. The MRI Magnet Room door must be closed during subject setup to prevent entry by unauthorized individuals.

   7. The MRI operator will center the subject's head for the MRI scan. The MRI operator will verify that the ear protection is still in place.

   8. The MRI operator will provide the subject with the emergency squeeze ball and inform the subject that s/he can alert the MRI operator to immediately stop the scan by squeezing the ball.

   9. The Experimenter will make sure that the experimental audio and/or visual systems are working properly and that the subject can hear and see properly.

   10. The Experimenter must make sure that the MRI operator enters the appropriate subject code provided by the scheduling calendar into the subject name field of the scanner. See SOP106: Privacy.

   11. The Experimenter must keep in contact with the subject between scanning runs to make sure that the subject is comfortable and performing the task appropriately.

3. Following the conclusion of the experiment:

   1. The Experimenter is responsible for the proper filing of the screening and consent forms. They must not be left in the MRI suite.

   2. The Experimenter must escort the subject back to the reception area and remind them to retrieve their valuables from the locker.