Documentation and Tools

Policy 1:  Scheduling Protocol for Subject Procedures

It is the policy of the Center for MR Research to facilitate the scheduling of MR subjects by establishing a single scheduling policy.

Procedure

1. All subjects must be scheduled via the PI’s online scheduler account. The contact for scheduling accounts will be:
   Michel Flannery, MR Research Manager
   Phone (312)996-1251
   Email [email protected]
2. You must meet the following requirements before an account will be created:
   1. Have IRB approval for your study
   2. Submit a Budget Prep Form
   3. Sign and return the MR Budget Agreement
   4. Submit a Data Request and Fund Transfer Form
3. Please follow the scheduling instructions found on the link below:
   Scheduling Research Protocol for 3T

Sponsor: Director
Date: 5/13_rev2

Policy 2: Smoking Regulations

The 3T MR Research Program recognizes the health and fire hazards of smoking and, therefore, bans smoking on its premises.

Procedure

The 3T MR Research Program shall maintain compliance with the smoking policy set forth by UIC.
http://www.uic.edu/index.html/Chancellor/3_15_13.shtml

Sponsor: Director
Date: 5/13_rev2

Policy 3: Contrast Media Management

The Center for MR Research provides appropriate storage, use, distribution and administration of contrast media.

Procedure

Procurement and Storage:

All contrast media is purchased directly from the UIC Outpatient Pharmacy. Contrast media is ordered and inventoried by the MR Research Technologist. Quantity ordered is determined by the volume of examinations to be performed.

Control and Distribution:

The control and distribution are managed by the MR Research Technologist. The contrast media will be maintained in a locked cabinet appropriately designated for this purpose.

Administration:

The contrast media type, quantity and method of administration is determined by the Research Technologist after reviewing and identifying the subject’s provided medical history.

Monitoring:

During and following the contrast media injection, the patient is observed by the technologist. If any adverse effects occur, action will be taken according to the UIC Hospital and Clinics Policy No: G-21.02 “Management of Contrast Media at the University of Illinois Hospitals and Clinics”.

Sponsor: Director
Date: 5/13_rev2

Policy 1: Safety Precautions

It is the policy of the Center for MR Research to provide the following safety procedures for the subject and staff members.

Procedure

1. A. Subject Safety
   1. Transportation of UICMC subjects between UICMC Buildings will be done in compliance with CC 3.04 and CC 3.05 of hospital policy.
   2. Every effort will be made to observe the patients/subjects at all times while in the imaging room or hallway.
   3. Side rails or restraining devices must be used for patients transported by stretcher.
   4. Patients shall be properly immobilized while on the examination table.
   5. Proper assistance must be given when transferring the patient from the stretcher or wheelchair for an imaging exam.
2. Fire & Explosion
   1. In the event of fire, the fire alarm must always be activated and proper personnel shall be notified. All patients/subjects must be placed in a safe area, not left in the hallways.
   2. In the event of fire in an examination room, immediately turn off the main power switch.
   3. Always follow hospital fire instructions. Center for MR Research will always be in compliance with Hospital policy EC 1.01 and EC 1.02.
3. Personnel Safety
   1. When a staff member notices a defect in the equipment it should be reported immediately to the supervisor.
   2. If sparking or burning odor is noted the equipment should be turned off, the circuit breaker should also be turned off. It should be reported to the supervisor.
   3. If equipment that slides or rolls seems difficult to move or unstable, it should be reported to the supervisor.
   4. Equipment with sharp edges, missing guards or bent guides should be reported to the supervisor.

Sponsor: Director
Date: 05/13_rev2

Policy 2: Subject/Visitor/Medical Staff Safety

It is the policy of the Center for MR Research to provide guidelines for patient/subject and members of the healthcare team and visitor safety while in the MR environment.

Procedure

1. All individuals entering the MR suite
   1. Screening must be completed on all subjects prior to entering the magnet room. The assessment form must be completed and signed. Orbital CT, x-ray, etc will be required on all subjects who have a history of metal in the eyes before entering scan room. *NO INDIVIDUAL MAY ENTER THE MR SUITE WITHOUT THE PRESENCE OF LICENSED MR PERSONNEL.
   2. Subject will be observed at all times while in the magnet.
   3. Subject shall be properly immobilized while on the MR table.
   4. Proper assistance must be given when transferring the subject from the stretcher or wheelchair for an MR exam.
   5. If there is a reason to believe a subject may be pregnant, she will not be examined. The PI will be notified immediately.
   6. Subject should be notified to advise staff of warm or strange sensations while in the magnet.
   7. Subjects with aneurysm clips and/or any implanted device will not be placed in the Center for MR Research scanner until we are in possession of documentation stating that the aneurysm clip and/or implanted device has been tested safe for 3T. The document must include the following information:
      1. manufacturer of the medical device
      2. make and model,
      3. where the surgery was done.
   8. Any subject participating in MRI imaging must have hearing protective devices IN PLACE before proceeding with scan.
   9. Staff is required to check under EKG patches and gating devices at patient contact locations at regular intervals throughout the exam on patients sedated or unable to communicate a problem.
   10. Subject exposed regions should not be allowed to come into contact with the bore of the magnet (housing) itself. Pads will be placed between subject and the bore.
   11. All unnecessary/extraneous electrical conductors should be removed from the bore during imaging.
   12. Care should be taken to ensure that no unnecessary loops are made by any electrical conductor in the imaging system. These include such entities as EKG, gating wires, surface coil leads, etc.
   13. The Subject’s skin should not be involved in any electrical conductive loop. EKG lead should be braided around each other to decrease the possibility of forming a large radius loop. However, EKG, surface coil and pulse oximeter cables should not be braided together as this may interfere with monitoring capabilities. These wires should also be kept as far as possible from the walls of the magnet bore.
   14. EEG fMRI: Subject needs to consult PI of the study.
   15. Thermal insulators (including space/air) should be used between any electrical conductor device and the subject to ensure that the potential for burns from the thermal conductivity from electrical conductors in the imaging system with the subject would be minimized.
2. Subject Medical Emergency
   1. All medical emergencies involving patients in the magnet room should observe the following procedures:
      1. Check subject status.
      2. Press Stop Scan button on console immediately.
      3. Open Scan door. If the subject is in cardio insufficiency then, notify emergency personnel (Call 9-911. Say “, 980 Building, 2242 Harrison (AIC).” specify adult or pediatric depending on age of subject. Provide your name, telephone number, and subject name, if known, and specify that we are a MRI facility)
      4. Evacuate subject by depressing the emergency release located at the foot of table. Push table slightly forward and pull cradle out of magnet until fully retracted. Unlock table by pushing emergency release button.
      5. If surface or head coil is in use, disconnect prior to removing table from position.
      6. Transfer subject to the waiting area just outside the 3T MR Suite.

Sponsor: Director
Date: 5/13_rev2

Policy 3: Guidelines For Handling Sharps

It is the policy of the Center for MR Research to provide guidelines for the handling of sharps, reusable sharps, and the safe and proper disposal of contaminated and other sharp material. This is consistent with the UIC Policy.

Definition

Sharps are generally disposable items, which are used to puncture or cut through the skin for medical/surgical procedures. All sharp items when handled improperly may cause not only a laceration but also infection.

1. Disposable sharp items include but are not limited to:
   1. Disposable plastic syringes with needles.
   2. Disposable glass syringes with needles.
   3. IV administration sets (intercath, butterfly needles, etc.)
   4. Blood collecting needles.
   5. Lancets, pinprick, suture needles.
   6. Disposable cutting blade (razors/scalpels)
   7. Glass ampoules, broken glass
   8. Disposable metal pharmaceutical seals, i.e. as on IV bottles
   9. Pipettes

Procedure

1. Storage of Sharps
   1. Unused syringes and needles are kept in a location in order to prevent unauthorized use.
2. Handling of Sharps
   1. Wash your hands prior to handling sharps. This decreases the chances of infection. Wear gloves to protect you from surface contamination, when appropriate.
   2. Avoid touching the sharpened edge/point.
   3. Keep the protective covering in place (while transporting the sharps) until the sharp item is needed.
   4. Never carry sharps in a pocket without a plastic cap in place.
   5. Discard all the disposable sharps according to instructions below.
   6. Remove all full contaminated boxes as outlined below.
3. Guidelines for disposing of disposable sharps
   1. To discard disposable needles/syringes or any other potential sharps that have been used in normal situations or isolation cases.
      1. After injection do not recap the needle.
      2. Take the used sharp to the nearest sharp disposal box
      3. Place entire needle and syringe in container
      4. Take care not to overfill the box
      5. Never place used sharps in the regular trash.
   2. Procedure for disposable needles/syringes ampoules contaminated with radioactive materials.
      1. After injection recap the needle, except butterflies. Safe needle recapping is required.
      2. Place entire item in the red cover sharps box provided for that purpose.
      3. Never place used sharps in the regular trash.
4. Procedure for removing full contaminated boxes
   1. Needle boxes or Sharps containers.
      1. Close opening and secure.
      2. Contact housekeeping for pick up of the full box. The full box should be picked up by housekeeping services
      3. Place the new empty box in service immediately.
   2. If the disposable needle box contains radioactive material
      1. Close the lid, label and date.
      2. Place the entire box in the area for holding radioactive decay storage.
      3. When the material is safe radiation safety will supervise the incineration.
5. Guidelines to follow when a cut or puncture wound occurs when handling sharps:
   1. Press a few drops of blood to minimize contamination.
   2. Wash site for 10 minutes with antibacterial soap and running water.
   3. Apply cold water to area to stop bleeding.
   4. Try to determine if the item involved was clean or contaminated. IF the case is unknown, consider it contaminated. Try to determine if used on a particular patient. If used on an outpatient, request that the patient wait for potential blood work.
   5. Immediately inform the supervisor and secure a medical evaluation per HMPP HR 1.01 (At all times to Emergency Services Department (ESD) for severe injuries and for serious work related injuries. During normal business hours to University Health Services (UHS). During non-business hours and on weekends and holidays ESD. An employee initially seen in ESD must report to UHS on the next business day.)

   SEE ALSO HMPP IC 3.01A for Management of Employee Exposure to Blood and Body Fluids.

Sponsor: Director
Date: 05/13_Rev2

Policy 4: Infection Control/Universal Precautions

It is the policy of the Center for MR Research to protect both the subject and the department staff by minimizing the exposure to communicable disease. Further, it is the policy of the Center for MR Research to provide a safe environment for patients, subjects, employees, students, and volunteers through minimizing the risk of transmission of infectious diseases that are blood/body fluid borne. To facilitate these policy objectives, universal precautions will be maintained as described in UIC Policy.

Definition

Universal precautions

Universal precautions define any patient as potentially infectious and recommend the use of barrier protection and equipment where appropriate.

University of Illinois at Chicago Hospital

In addition to the use of Universal Precautions for all subjects, the UICH utilizes additional Isolation/Precautions described below.

Isolation Precautions

1. Strict – to prevent transmission of all highly communicable diseases that are spread by both contact and airborne routes of transmission.
2. Respiratory – to prevent transmission of organisms by means of droplets and droplet nuclei that are coughed, sneezed or breathed into the environment.

Precaution Types

1. Direct Contact – to prevent transmission of epidemiologically significant microorganisms by personnel having direct contact with patient/subject body sites colonized or infected with such organisms.
2. Chicken pox/Shingles – to prevent employees susceptible to chicken pox from acquiring infection from patients/subjects with chickenpox/shingles.

Procedure

1. Strict Isolation – highly communicable disease transmitted by both the respiratory route and by direct contact.
   1. The imaging and waiting room to receive a strict isolation patient should have all unnecessary ancillary equipment removed.
   2. The strict isolation patient will be taken directly into the designated exam room and will not be left in the halls or waiting area.
   3. The patient should be wearing a gown and a mask.
   4. Only a limited number necessary imaging staff will be in the room during the procedure.
   5. Precautions:
      1. Gowns – individual gown technique is imperative for all persons entering the room.
      2. All persons entering the room must wear masks.
      3. Hands must be washed with Betadine for at least 30 seconds before and after contact with he patient.
      4. All persons entering the room must wear gloves.
      5. All disposable dressings, or other contaminated disposable items should be put into red hazardous waste bags prior to leaving the room. Linen should be put into the red plastic bags and handled as contaminate/biohazardous.
      6. All needles and sharps should be placed in impervious plastic needle boxes available in each room. Needles should never be recapped. See Safety Policy 4.
      7. Special procedure trays and special instruments should be separated into: a) disposable, b) autoclavable, c) linen, etc. The instruments and trays should be seen to Central Service for decontamination/sterilization. Routine inspection of holding areas for outdated trays and supplies is mandatory. Linen should be placed in blue linen bags and handled as contaminated.
      8. During or immediately following the procedure, the Housekeeping Department should be notified that the exam room and equipment must be cleaned.
      9. No personnel should enter the exam room until it has been cleaned.
2. Respiratory Isolation – infectious droplets that are coughed, sneezed or breathed into the environment. Childhood diseases including mumps, rubella (German measles), and measles are put into this category.
   ATTENTION: Pregnant staff members should not perform examinations of rubella patients
   1. Imaging room should be ready to receive the patient as soon as possible upon his/her arrival.
   2. Patient should be wearing a mask during transport and the procedure, if possible.
   3. Precautions:
      1. Gowns are not necessary, unless dictated by Universal Precautions needs.
      2. Masks are necessary while in close proximity with the patient. (This includes all persons entering the exam room.)
      3. Hands must be washed with Betadine for at least 30 seconds.
      4. Gloves are not necessary, unless dictated by Universal Precautions needs.
      5. Needles and syringes – needle box – disposed by Housekeeping.
      6. Dressings and tissues should be put in red hazardous waste bags to be incinerated without being opened.
      7. Linen – blue plastic bags.
      8. The patient’s chart may be taken into the room
      9. Normal housekeeping procedures.
3. Cleaning Procedures in Patient Care Areas
   The pulse oximeter and sensor, dynamap, etc. should be cleaned after every patient use with a low level disinfectant. Visible contamination with blood should be cleaned with 10% Clorox solution.
   Instrumentation is cleaned after each patient use with alcohol or bleach solution. Patient restraints are soaked in a Clorox solution for disinfection.
   Any employee who experiences a needle stick or cut with a sharp instrument or a splash of blood or body fluids into a mucous membrane (eye, nose, mouth) should report to their supervisor and University Health Services. See Safety Policy 4.
   Outdated materials and items must be discarded appropriately.
   Please see Hospital Policy IC 1.02, 1.03, 2.01, 2.02, 2.03, 2.04, 2.05, 3.01A, 3.01B, 3.02, and 4.00 for more detailed information regarding any of the above items. The Center for MR Research will always comply with UICMC Hospital policies on infection control.

Sponsor: Director
Date: 05/13_Rev2

Policy 5: Equipment Safety

It is the policy of the Center for MR Research to provide guidelines for maintaining equipment safety. There is an equipment management program designed to assess and control the clinical and physical risks of fixed and portable diagnostic equipment. Written criteria will include the characteristics of equipment function, clinical application, maintenance requirements and equipment incident history.

Procedures

All patient care monitoring equipment shall tested prior to use when new, after any repairs are made, and at intervals not to exceed 6 months thereafter.

Before a new piece of equipment is used, the medical physicist in Radiology evaluates it, and the evaluation is documented. In compliance with University of Illinois at Chicago Radiology Policy 05-02-0005

Equipment such as leads, EKG, pulse oximeter, surface coils, should be checked by Center for MR Research staff prior to each patient application.

Staff shall report any defective equipment.

Equipment with sharp edges or missing guards should be reported to the supervisor.

If the oxygen alarm sounds, immediately open the scan room door. Stop scan by pressing the Stop Scan button on the MR console. Evacuate the area. In the event that the scan room door should ever jam, access to the scan room can be achieved through the view window.

Notify equipment service engineer to remove any metal object(s) that may be in the field or stuck to the side of the magnet. Trying to remove the objects yourself could result in a serious personal injury or spontaneous quench of the magnet.

Sponsor: Director
Date: 05/13_rev2

Policy 6: Power Failure – Emergency

To continue essential services during a power failure, Center staff should be aware of and observe emergency procedures applicable to power failure.

Procedure

Electrical service maintained by emergency power:

1. Minimal hallway lighting
2. Emergency hallway lighting (red lights)
3. ID Activated doors
4. Telephones
5. Selected wall receptacles (red plates)

ACTIONS TO BE TAKEN

1. Identify immediate priorities –subject and staff safety
2. Organize available resources to meet immediate priorities
3. Determine extent of power failure
   1. local failures such as circuit breakers affecting an outlet, room or a small section
   2. major failure affecting entire building or portions of the campus
4. If emergency power is available, plug life sustaining equipment into receptacle on emergency power system (red plates)

FOR ALL POWER FAILURES

1. Notify Steve Cross at 312-355-0879
2. Notify Facilities Management at 6-7511
3. Notify Director or designate on call/duty
4. Reassure subjects that they are in no immediate danger.

Sponsor: Director
Date: 5/13_rev2

Policy 7: Cardiopulmonary Resuscitation

The Center for MR Research recognizes that the patient, staff, or visitor who experiences the sudden, unexpected cessation of cardiopulmonary functions, is best managed by an interdisciplinary team trained and equipped to implement cardiopulmonary resuscitation (CPR). All Center for MR Research staff will be certified in Basic Life Support (BLS – Adult/Pediatric); Advanced Cardiac Life Support (ACLS); Pediatric Advanced Life Support (PALS) and will maintain current certification throughout their employment with the Center. Documentation of current certification must be maintained in each staff member’s human resource file.

Procedure

1. In the event that someone within the care or vicinity of the 3T MR Research Service experiences an unexpected cessation of cardiopulmonary functions, DIAL 9-911.
   Say “980 Building, 2242 Harrison (AIC).” Specify adult or pediatric depending on age of subject. Provide your name, telephone number, and subject name, if known, and specify that we are a MRI facility)
2. Any Center for MR Research staff who initiates CPR must be trained as a basic life support provider.

Sponsor: Director
Date: 5/13_rev2

Policy 8: Quality Assurance Procedures

Policy 3T Scanner and SCS Quality Assurance is performed daily or a minimum of every other day.

Procedure

Daily QA

1. Daily EPI & DWI QA
   1. Setup the red TLT sphere (with “fill hole” at bottom) in 8ch Head coil and landmark at center of phantom
   2. Advance to scan and make sure all ancillary room equipment is powered off (Allow the TLT sphere to sit for 5-10 minutes prior to running to allow the fluid to “settle”)
   3. Close scan door and turn off all room lights
   4. Start a new exam and download/run “Daily QA” protocol located under the “Other” category
   5. Transfer data to the SCS and process and save

SCS QA

1. Turn on all equipment and check to see if functioning properly:
   1. Boot up SCS: PC Workstation, LCD Monitor, and SCS control box.
   2. Turn on Pulse oximetry.
   3. Turn on eye camera and LCD viewer.
   4. Install and check LED illumination on coil.
   5. Turn on projector: Apply power and press POWER button to operate projector lamp.
   6. Start the SCS software.
2. Perform projector QA and image alignment:
   1. Check visor transparency – Install the transparency if it has been removed. The transparency on the visor must be checked to make sure that it is in the proper position. The position of the fixation cross on the transparency should be 10.6 cm from the left screen inside edge and 4.5 cm from the top screen inside edge.
   2. Check the projector trolley wheels for dust – this can offset vertical alignment.
   3. Check that cables do not interfere with projector movement.
   4. Confirm that the Head Coil base is correctly seated and clamped on the patient table. This affects the visor screen alignment.
   5. Line up the projected cross with the cross on the visor. The file “QA paradigm.avi” is projected and is used to align the projected fixation cross with the cross on the visor.
3. Run the QA paradigm to check the projected image:
   1. The width of the projected image should be 7 inches when land marked according to the QA marker located on the visor.
   2. Check for dust in the lens. Look for color specks in a dark background.
   3. Check for any delays within the paradigm or any flashing of the projected image.
4. The SCS system is used to record the following data to a file. File is then checked.
   1. Respiratory
   2. Cardiac
   3. SpO2 level
   4. Trigger signal from GEMS 3T
   5. Finger switches

Sponsor: Director
Date: 05/13_Rev2

Policy 9: Subject Safety and Screening for 3T Examinations

All subjects for 3T MRI studies must have proper screening documentation. It is the responsibility of the technologist performing the exam to read all attached subject documentation prior to placing any subject into the 3T scan room.

Procedure

Contraindications

* Any subject with a known and well documented medical device that is NOT deemed SAFE at 3T will not be scanned at 3T. Note: The steps listed below are consistent with standard practice.

Research Subject Exams

1. All subjects MUST have the “Subject Screening Form” filled out in its entirety.
2. The person scheduling any subject will be responsible for obtaining the responses from the subject or guardian for the “Subject Screening Form” prior to scheduling an appointment.
3. All aneurysm clips, heart valves, and other well known MRI medical device safety hazards will require proper identification and documentation prior to scheduling or entering the 3T scan room.
4. All questionable medical devices will require full documentation of the Make, Model, and date the device was implanted without exception.
5. The technologist is to bring the subject screening form to either a board certified Radiologist or Research Manager to check for potential risks prior to taking any patient in the 3T room.
6. It will be the responsibility of the scanning technologist to evaluate continued patient safety throughout the exam.
7. All unknown artifacts seen on an image(s) should be immediately questioned and the scanning technologist should seek expert advice from a radiologist and/or another qualified technologist before proceeding with the exam.

Sponsor: Director
Date: 05/13_rev2

Policy 1: Research Accounts

It is the policy of the Center for MR Research to manage the resources of the Center by requiring each investigator to set up a Research Account for each of their protocols.

Procedure

The forms and directions for setting up a Research Account may be found at the website for the Center for MR Research Documentation and Tools

1. Submit the following documentation to the Research Manager Mike Flannery at
   [email protected]
   1. CMMR Budget Preparation Worksheet
   2. IRB protocol and approval number (state if it has been submitted but pending approval).
2. A MR Resource Agreement will be created based upon the submitted Budget Prep data.
   1. The completed form will be faxed or emailed to the PI for approval and signature.
   2. Fax or email back to Mike Flannery
   3. All Pending Accounts expire after 12 months. If you have a Pending study that is awarded funding, PLEASE INFORM Mike Flannery ASAP in order to proceed creating your 3T Research account.
   4. Send all PAF’s to Mike Flannery to obtain the necessary 3T Program signatures. You must have a signed MR Resource Agreement prior to obtaining PAF signatures
3. All Research Accounts must have a Fund Transfer Form submitted
   1. Complete and sign a “Research Imaging Fund Transfer Form”
   2. Fax or email back to Mike Flannery
4. All Research Accounts must have a Data Destination Request Form submitted
   1. Complete and sign a “Data Destination Request Form”
   2. Fax or email back to Mike Flannery or Hagai Ganin
5. The PI will be given access to the online scheduling system once all forms are submitted to the 3T MR Research Program.

Sponsor: Director
Date: 05/13_Rev2

Policy 2: Informed Consent for Research Protocols

Before the initiation of any human subject research at the Center for MR Research, the Institutional Review Board (IRB) of the University of Illinois at Chicago must approve the protocol, the informed consent document, and any written solicitation for subjects. No human subject research shall occur at the Center of MR Research without the approval of the IRB and with the research subject’s voluntary written consent, except as noted below.

A principal investigator may address questions regarding research protocols and informed consent requirements to the chair of the IRB or to the University’s Office for Protection from Research Risks in the Office of the Vice Chancellor for Research.

The Center for MR Research will perform consistent with UICMC policy and procedures governing the use and control of investigational drugs (see TX 3.07 Use and Control of Investigational Drugs).

For the purpose of this policy, the following definitions apply:

Research is a systematic investigation designed to develop or contribute to generalizable knowledge or the acquisition of data, which may in the future be used to develop generalizable knowledge.

Protocol is any plan of an experimental nature, including plans relating to investigational drugs and investigational medical devices.

Principal Investigator (PI) is a person responsible for the conduct of the research or clinical trial at a trial site. If a trial is conducted by a team of individuals at a site, the investigator is the responsible leader of the team. It is the individual under whose direction the research conducted.

Research subject is a patient or healthy volunteer from whom the PI conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Procedures

PRINCIPAL INVESTIGATOR/CO-INVESTIGATOR(S):

1. 1. 1. Seek and obtain approval of the research protocol and informed consent document from the IRB prior to the collection of data.
      2. Obtain written informed consent from all subjects in the research protocol, except in those cases where specific written informed consent is not required because the protocol has been exempted in advance by the IRB.

   NOTE: THE RESPONSIBILITY FOR OBTAINING WRITTEN INFORMED CONSENT CANNOT BE DELEGATED.

   1. Prior to the collection of any data, discuss the research protocol with the subject. At a minimum, provide the following information to the subject:
      1. A statement that the study involves research, an explanation of the purpose of the research, the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
      2. A description of any reasonably foreseeable risks or discomforts to the subject;
      3. A description of the potential benefits to the subject or to others, which may reasonably be expected from the research or a statement that no benefits are expected.
      4. A disclosure of appropriate alternative procedures, if any, that might be advantageous to the subject;
      5. A statement describing the extent to which the confidentiality of records identifying the subject will be maintained;
      6. A statement that the subject’s refusal to participate in the research study will not jeopardize the subject’s receiving medical treatment at UICMC;
      7. A statement that the subject’s consent, once given, may be withdrawn at any time;
      8. A statement noting whether compensation is available and whether any medical treatment is available if injury occurs and if so, who to contact in the event of a research related injury;
      9. A clarification that costs of treatment (i.e. those entirely outside of the research protocol) are the responsibility of the subject.
      10. A notice of a contact for questions regarding the research protocol and the research subject’s rights.
   2. Have subject or subject’s legally authorized representative (or the parent if the subject is under 18 years old unless the minor subject is legally considered an adult) sign the informed consent document in own presence.

1. NOTE: A witness who was present at the signing of the informed consent document and the PI must also sign the form. If a minor subject is age 12 or older, his or her assent should be obtained in addition to the consent of the minor subject’s parents or legally authorized representative.
   1. Place one copy of the signed informed consent document in the patient’s medical record and record a statement in the progress notes that the informed consent discussion occurred and that the consent was obtained. Give a copy of the informed consent document to the subject. Retain the original, signed informed consent document.

NOTE: When the Center for MR Research is only providing imaging services for another Investigator’s research protocol, a copy of the appropriately executed Informed Consent Form and a copy of the Center for MR Research Patient Safety screening form will be kept in a file established for that protocol. THE PI OR HIS CO-INVESTIGATOR NOT CENTER FOR MR RESEARCH STAFF IS RESPONSIBLE FOR THE INFORMED CONSENT PROCESS PRIOR TO SCANNING.
1. In the extremely rare circumstance, if the informed consent discussion did not occur or if the written informed consent document was not signed, notify the IRB within 5 working days regarding the circumstances associated with the failure to obtain the subject’s consent.
2. If any medication is to be given to or procedures performed on a subject who is a patient at UICMC for other reasons as part of the research protocol, inform the attending physician with primary responsibility for that patient’s care. The responsible attending physician must write orders accordingly. These experimental procedures shall be charted in the patient’s medical record in a manner consistent with other procedures (TX 3.07 Use and Control of Investigational Drugs.)

Sponsor: Director
Date: 8/01

Policy 3: Research Time Billing

Research scanner time will be billed by the CMRR each month. Only those researchers with approved funded research accounts will be allowed to schedule research scanner time.

Procedure

1. Each Researcher will be assigned an internal research account for each study undertaken. This account is used in scheduling scanner time.
2. The MR Research Technologist records the amount of time used on the daily report and in the MR record book for each study.
3. The reports are turned in to the Research Manager for verification.
4. The CMRR records the amount of time used by account.
5. The CMRR generates a bill using the departmental accounting system on a monthly basis to each researcher.
6. Each PI will receive an email with their monthly statement detailing the scan time that was used. The PI will have one week (5 working days) to review the charges. If there are no billing disputes, the account specified by the PI will be charged for the amount owed for that billing cycle.

Sponsor: Director
Date: Rev 2, 02/13

Policy 4: Research Access to Synchronization Control System (SCS) projection system

It is the policy of the Center for MR Research to facilitate the successful utilization of all functional data producing equipment.

Procedure

Signal input to the projector is provided through a type D-subminiature, high-density (HD) 15-pin female, VGA graphics connector. This connection is located on the front panel of the Research Access Switch Box located in the SCS rack. This common connection is able to connect to all standard laptops and desktops, via standard VGA graphics cables, which have HD 15 pin male connections. All input signals should be formatted for 640×480 resolution and 60Hz refresh rate. Maximum projector capability is 24 bit, 16.7 million colors. The native resolution of the projector is 640 x 480.
Sequence of Set Up

1. Carefully connect and secure the graphics cable to be used with the HD 15 pin connector. Connect the graphics source PC to the graphics cable and power up.
2. Press the button switch. The graphics from the source PC will be displayed by the projector after a short delay for signal synchronization.
3. Confirm that the resolution and other format details are correct for the projector display.
4. NOTE: The projector box is not to be opened. The projector lens is set for desired focus. If this – or any other – SCS display adjustments need to be altered during research:
   1. Get permission from the MR Research Specialist to change settings.
   2. Record these changes immediately in the 3.0T log book.
   3. Return these settings to the prior state at the end of the research slot.
5. Upon completion of the research, remove the alternate graphics cable. Replace and secure the SCS graphics cable in the input connector.
6. Confirm with the MR Research Specialist that the system is operating correctly.

Sponsor: Director
Date: 5/13_Rev2

Policy 5: Scanner Usage Following Non-Human Subjects

Following studies on non-human primates, the scanner must be clear for one hour.

Procedure

1. All surfaces must be cleaned and bleached including equipment, tables, scanner bed, etc.
2. Human subjects are not to be scheduled for one hour after a primate has been scanned.
3. The air circulation must be turned over four times after a primate has been scanned before a human subject may go into the scanner. It takes one hour for the air circulation to be turned over four times.

Sponsor: Director
Date: 05/13_Rev2

Policy 6: Research IRB/ACC Compliance

The 3T MR Research Program of the CMRR shall not be responsible to oversee IRB and/or ACC compliance for each Principal Investigator’s study(s).

Procedure

1. The PI is solely responsible for obtaining IRB and/or ACC approvals for any study that requires IRB and/or ACC approvals according to the University policies. The PI is also solely responsible for the governance over their approved IRB or ACC research.
2. It is the responsibility of the PI to maintain compliance and strictly follow the regulations set forth by the UIC IRB and ACC.
3. Upon the PI’s request, the 3T MR Research Program of the CMRR will provide MR safety guidelines according to Federal, State, and local regulations.

Sponsor: Director
Date: Rev 2, 05/13

Policy 7: Research Equipment Storage

Research user groups may be allowed to store portable research equipment onsite, depending on space availability.

Procedure

The CMRR 3T Research Program may provide an area outside the magnet room to store portable equipment (e.g., equipment cart) for research investigators, depending on space availability and subject to the following procedures and policies.

1. The request must be submitted to and approved by the 3T MR Research Program.
2. At 2242 West Harrison Street, the University insurance policies do not cover equipment in the building.
3. The CMRR 3T MR Research Program assumes no responsibility to theft or damage to any equipment left onsite.
4. The research user group is responsible for locking up all equipment within the equipment cart.

Sponsor: Director
Date: Rev 2, 05/13

Policy 8: MR Research Involving Non-Human Subjects / Biological Specimens

The Center for MR Research requires full compliance with UICMC policy IC 6.00 in order to conduct non-human subjects / biological specimen imaging on the Hospital MRI scanners.

Procedure

Approval from the UIC Medical Center must be granted for any Non-Human / Biological specimen imaging projects to be done on the hospital MRI scanners. The CMRR 3T Program requires the completion of the following steps prior to starting any MR research project involving non-human subjects and/or biological specimens on clinical MRI scanners.

1. Please contact CMRR-3T Research Manager (Mike Flannery) to request the “CMRR 3T Request Form for Non-Human Subjects / Biological Specimen Imaging” (thereafter referred to as the Form).
2. The Principal Investigator (PI) must complete, sign, and date the Form.
3. If the Biological Resources Laboratory (BRL) is involved in the project, it is the PI’s responsibility to obtain the signature from BRL on the “CMRR 3T Request Form for Non-Human Subjects / Biological Specimen Imaging”.
4. The Form with the PI’s signature and the BRL signature (if applicable) must be e-mailed to the CMRR-3T Research Manager (Mike Flannery) for CMRR- 3T approval.  The CMRR -3T Research Manager will then send the form to the Hospital for approvals by the Hospital Department Director and Medical Director of Infection Control.
5. The PI will be notified once the Hospital approvals are granted.  With all approvals, the study may commence.
6. The hours of operation for MR research involving non-human subjects / biological specimens are Monday – Friday between 10:30PM and 6:30AM.
7. All other policies, including PI’s responsibility to obtain ACC approvals, remain the same.

Sponsor: Director
Date: 6/14_Rev2

Policy 9: Cancellations for Coupled Research Studies

Research scanner time for coupled research studies that is cancelled within the 48 hours cancellation policy will only incur a partial charge.

PROCEDURE

 1. Any PI’s research protocol that requires 2 scan sessions per subject by design (i.e. Day 1, Day 2), will only be billed for the 1^st scan charge if the scan is cancelled within 48 hours of the 1^st scheduled scan.

2. Any PI’s research protocol that requires booking 2 consecutive coupled scans with 2.5 hours or more of scheduled scan time, will receive a 1hour credit if the scan is cancelled within 48 hours of the scheduled scan time (e.g., 2.5 hours will only be billed 1.5 hours, 3 hours will only be billed 2 hours, etc).

Sponsor: Director
Date: 09/18_Rev2

Policy 1: Research Source Documents

The Center for MR Research understands the need for security and confidentiality of research source documents. All data storage devices (paper, diskettes, CD, Optical Disks, etc.) are kept in a locked cabinet to which only Center for MR Research Staff has access.

Procedure

1. 1. A file will be created for each human research subject (patient/healthy volunteer) participating in a 3T CMRR specific IRB. This file will contain the Center for MR Research Safety Screening Questionnaire, the original Informed Consent Form subject identification information for demographic database purposes, medical history available, TIF copies, dictated report hardcopy, payment vouchers if applicable, tracking sheet for each visit, and copies of any correspondence or notes on communication.

Note: The Center for MR Research Safety Screening Questionnaire will be kept on file for all non-CMRR specific IRB studies

1. The files will be kept in a locked cabinet to which only the MR Research Staff has access. Files removed from the cabinet will be tracked by the 3T CMRR Technologists such that all files may be located at any given time.
2. A database of all research subjects will be maintained and kept secured by the Research Technologists.
3. None of the source documents will be removed from the Center for MR Research at any time without the written consent of the Director of the Center or the IRB.

Sponsor: Director
Date: 05/13_rev2

Policy 2: Confidentiality of Research Data

The Center for MR Research provides a service for many individual investigators. Since some of these investigators may be involved in similar research, the confidentiality of the individual investigators research data must be secured such that it cannot be used by anyone but the investigator or his/her designates.

Procedure

The Center for MR Research staff will be responsible for moving data from the scanner to other storage devices on completion of the scans performed by the Center for MR Research staff in a timely fashion. The Staff will also be responsible for the security of any data storage media consistent with Good Clinical Practices.

If the Investigator or his/her designate performs the scan involved in their research, the Investigator or his/her designate is responsible for removing the information from the scanner workstation as soon as the scan is complete. The Center for MR Research will not be responsible for the confidentiality of the information left on the scanner after completion of the study.

Sponsor: Director
Date: 05/13_rev2

Policy 3: Medical Records: Release of Information

The Center for MR Research restricts the release of medical information and medical records. (see HMP IM 4.03 Medical Records: Release of Information).

Procedure

1. All requests for medical information must be in written form and accompanied by a properly executed Release of Medical Information Form signed by the Patient/Subject or their legally-authorized representative specifying the medical records to be released.
2. No medical information originating outside the Center for MR Research which may be contained in the Center for MR Research files may be released for any reason. The requester should be referred to original source.
3. If the requested information is contained in the Patient/Subject’s Medical Record at UICMC, the request and release should be forwarded to the Medical Records Department for response.

Sponsor: Director
Date: 05/13_rev2

Policy 4: Subject: Internet Protocol (IP) Address

It is the policy of the Center for MR Research to secure all Patient/Subject information such that unauthorized access is not possible.

Procedure

An Internet Protocol Address may not be added or given to staff not specifically allowed access to Patient/Subject data as part of their normal duties.

A non-Center employee may not have an IP address established without the written permission of the Director of the Center. A copy of the authorization with dates will be kept on file.

Sponsor: Director
Date: 05/13_rev2

Policy 5: Creating paradigm files for SCS

It is the policy of the Center for MR Research to facilitate the successful utilization of all functional data producing equipment. Consistency in the methodology used to create the data promotes this success.

Procedure

1. All paradigms should be movie files, consisting of a series of frames to be played sequentially.
2. The resolution of the files should be standard VGA, that is, 640 pixels wide and 480 pixels high.
3. All movies should play at 30 frames per second, regardless of the rapidity of motion (or lack thereof) in them.
4. If color is used, the bit depth should be adjusted to 24 bits, providing 8 bits of resolution each in the red, green and blue channels. For paradigms without color, 2 bit or 8 bit grayscale may be used. Please choose 8 bit if possible, since anti-aliasing cannot be done at 2 bit depth.
5. Any software can be used to produce the movie files, however, we recommend Adobe Premiere.
6. If the movie files contain accompanying audio information, the maximum resolution permitted for audio is two channels at 16 bits and a sampling rate of 44.1 kHz.
7. Video Signal Encoding: this must be MPEG-2 only. No other encoding methods are acceptable. You may enclose the files in an AVI wrapper, proving that MPEG-2 was used as the encoding method. We recommend the MPEG-2 encoder included with Pinnacle DV500 Plus.
8. Audio Signal Encoding: this must be mp3 compatible. Variable or constant bit rates may be used, but the data stream should not average more than 64 kbits/s.
9. We recommend anti-aliasing if motion is present in the paradigm.
10. Microsoft Media Player is used to play the movie files in the SCS. However, Media Player can use many codecs, which may or may not be installed on our system. The fact that the movie plays in Media Player on your computer is no guarantee that it will play on the SCS. Please test your paradigm on the SCS at least a day or two before using it on a subject.

Sponsor: Director
Date: 05/13_rev2

Policy 6: Notification of maintenance to shared computing resources

Notification of maintenance to shared computing resources will be made to all affected users prior to performing maintenance.

Procedure

1. Notification of planned maintenance that may affect availability of a shared computing resource (e.g., data server, network printer, computing cluster, license server, shared workstation, etc.) will be made to the entire department via email at least 48 hours prior to beginning maintenance. This notification will be repeated 1 hour before beginning maintenance. The notification will describe the maintenance to be performed, the need for the maintenance, the expected time to complete the maintenance, and the availability of the computing resource during maintenance.
2. Notification of unplanned (emergency) maintenance that may affect availability of a shared computing resource (e.g., data server, network printer, computing cluster, license server, shared workstation, etc.) will be made to the entire department via email at least 10 minutes prior to performing maintenance. The notification will describe the maintenance to be performed, the need for the maintenance, the expected time to complete the maintenance, and the availability of the computing resource during maintenance. If data availability will be affected, a verbal notification will also be made to the entire department to minimize the risk of data loss.

Sponsor: Director
Date: 05/13_rev2

Policy 7: Image Data

It is the policy of the Center for MR Research to securely transfer image data off the 3T MRI scanners upon completion of the exam.

1. Image data will be transferred to the location designated by the PI on the Data Destination Request Form.
2. The PI will have 24 hours after the completion of the MR exam to verify that all image data was received. After this time period, the 3T Program of the Center for MR Research shall not be liable for any missing image data.
3. The 3T Program of the Center for MR Research is not responsible for backing up the image data and the associated software such as pulse sequence files used by the PI. It is the responsibility of the PI to back up all study data.

Sponsor: Director of the 3T Program
Date: 01/14_rev1

Policy 1:  Safety

It is the policy of the Center for MR Research to provide guidelines for Principal Investigators and Research Assistants.

Procedure

1. Notify the MRI staff of any change in medical history that could contraindicate working in an MR environment (e.g. pacemaker, aneurysm clip, etc.).
2. All individuals are required to complete and sign a “MR Safety Screening Form” prior to entering the magnet room.
3. All jewelry, loose metal objects, electronic devices, etc. must be removed from your person prior to entering the magnet room.

Sponsor: Director
Date: 10/2013_ver 1

Policy 2: Designated Eating/Drinking Areas

It is the policy of the Center for MR Research to provide guidelines for the consumption of food and drink by the staff on work premises.

Procedure

The only areas designated for food are the staff lounge, kitchen, and conference room. As a courtesy, beverages should be limited to areas away from the patients, physicians or visitors. In addition, beverages are not permitted in the labs or scanning areas and need to be kept away from all electronic equipment.

Sponsor: Director
Date: 05/2013_Rev2

Policy 3: Pregnancy

It is the policy of the Center for MR Research to provide pregnant faculty staff with information in the form of procedural guidelines during the pregnancy period.

Procedure

1. If you are pregnant, or suspect you may be, you must notify the MR research technologist operating the scanner on the day of your experiment.
2. Once pregnancy is suspected, individuals are advised not to remain in the magnet room during the scanning. PI’s and RA’s may monitor the subject from the control room and enter the magnet room to setup any research equipment when scanning is off.

Sponsor: Director
Date: 5/13_rev2