SOP108: Screening Subjects

  1. Summary

    All individuals must be screened prior to entry into the Magnet Room. This SOP establishes procedures for the proper screening of research Subjects, accompanying persons, and Visitors at the BIAC.

  2. Scope

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

  3. Definitions

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

    • Minor Subject - A subject below the age of eighteen is considered a minor.

    • Visitor - An individual who has not taken the BIAC safety course, but who has a legitimate reason for entering the MRI suites. Visitors may include students or faculty on a BIAC tour, sales representatives for MRI equipment, or assistants helping with experimental protocols.

    • 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.

  4. Policies and Procedures

    The purpose of screening is to determine whether individuals have metal or medical devices in their body, or on their persons, such that their entry into the Magnet Room would pose a health and/or safety risk to that individual, to another individual in the Magnet Room, or to the equipment in the Magnet Room. All individuals must be screened using the procedures outlined below and all individuals must complete a BIAC approved screening checklist.

    If the Subject is a Minor or is incapacitated, then the parent or legal guardian who is providing informed consent must be included in the safety interview and must sign and date the safety screening form.

    No individual may enter the Magnet Room without first being screened by an Experimenter with appropriate training. No individual may enter the Magnet Room if s/he have definite contradictions to scanning or if the Experimenter has any unresolved uncertainties. Err on the side of caution.

    1. Phone screening for MRI Subjects:

      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. Such contraindications include an implanted medical device such as a pacemaker or cochlear implant, metal or shrapnel in the body or eye, a tattoo on the face or neck, or permanent (tattooed) eyeliner.

      2. Phone screening should be used to advise Subjects against wearing certain clothing, jewelry, or makeup to the scanner session. Clothing and shoes with large metal clasps or metal decoration should not be worn. Women Subjects should be encouraged to wear a bra without metal clasps or underwires (such as a sports bra). Necklaces, earrings, bracelets, and other jewelry cannot be worn during scanning and should be left at home. As some mascaras and eyeliners contain metal pigments, Subjects should be cautioned against their use on the day of scanning. Makeup with glitter should not be worn.

      3. If the Subject wears glasses, the Experimenter should ask them for his or her correction as the Subject might have to wear corrective lenses from the BIAC stock. Question whether the Subject plans to wear contact lenses. Some colored or tinted contact lenses that alter the apparent color of the eye contain metal and cannot be worn in the scanner. If Subjects wear such colored contacts, ask them to wear their glasses and/or provide their correction.

      4. Depending upon the protocol, the Experimenter might advise against caffeine, smoking, drinking or other the ingestion of other substances prior to scanning. Some substances, such as caffeinated coffee, may act as a diuretic. Drinking coffee just prior to the scanning session may result in Subject discomfort during a long scanning session.

    2. Screening a Subject prior to scanning:

      1. The Experimenter will conduct a screening interview with the Subject. This includes, but is not limited to, the Subject filling out, signing, and dating an approved screening form for MRI Subjects.

      2. Subjects may not understand all of the questions on the form. For this reasons, the Experimenter must review the Subject's responses on the screening form with him or her. The Experimenter should expand upon some questions to make sure that the Subject can be safely scanned. For example, the Experimenter should ask if the Subject has ever had surgery. If the answer is yes, the Experimenter should ask whether any devices such as pacemakers, cochlear implants, neurostimulators, metal screws, staples, joints, plates, or shunts were implanted. The Experimenter should also ask about prior MRI studies and ascertain whether the Subject had ever been told they could not be scanned. Subjects who had previously been scanned with MRI should still be closely questioned as circumstances may have changed since their initial screening.

      3. The Subject must be dismissed if items are checked that are a contraindication for MRI, or if unresolved safety issues remain. Definite contraindications include implanted medical devices such as pacemakers or cochlear implants, implanted wires, shrapnel, or any metal fragments in the eye. Subjects who have a history of working with sheet metal or with metal lathes must be excluded unless they have been cleared by an orbital x-ray study.

      4. If there are uncertainties in the Subject's response to the screening form — for example, if a Subject recalls that they had a childhood accident that might have included getting metal fragments in his or her eye, then the Subjects cannot be run unless additional tests (orbital x-rays) are run to eliminate this possibility. Other uncertainties — such as whether a stainless steel metal screw in the knee contraindicates scanning — should be reviewed with a neuroradiologist or MRI physicist. Dr. Kanal's web site provides useful information regarding the safety of specific items or devices.

      5. The Experimenter must sign and date the screening form to verify that s/he has completed the interview and review.

      6. The Experimenter must ascertain that all metal objects — such as key chains, jewelry, are removed from the Subject's person prior to entering the Magnet Room. The Experimenter should remind the Subject of the items listed on the screening form that must be removed prior to entry into the scanner. Female Subjects must verify that they are not wearing bras with underwires or metal clasps. The Experimenter should look for common objects that the Subject may have overlooked, such as necklaces, watches, hair pins, earrings, metal belt buckles, pagers, or pens. Shoes with metal buckles, zippers, or nails must be left outside of the scanner room. Eye makeup such as mascara or eyeliner must be removed prior to scanning.

      7. The Experimenter must use the metal detector wand to double check for metal objects on the Subject's person. Questionable items can be tested with a handheld permanent magnet.

    3. Screening an accompanying person or Visitor to enter the Magnet Room:

      1. The Experimenter will conduct a screening interview with the Visitor or accompanying person. This includes, but is not limited to, the Subject filling out, signing, and dating an approved screening form for MRI Visitors or accompanying persons.

      2. The Experimenter should follow the identical procedures as indicated above for MRI Subjects with the following exceptions: Visitors or accompanying persons do not generally need to remove belts or shoes prior to entering the Magnet Room. Female Visitors or accompanying persons do not need to remove eye makeup. Bras with underwires of metal clasps do not pose a danger for female Visitors or accompanying persons who do not enter the magnet bore.

SOP