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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 cmrr3t.uic.edu/documentation_and_tools

  1. Submit the following documentation to the Research Manager Mike Flannery at
    mpflanne@uic.edu
    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. 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.
  3. NOTE: THE RESPONSIBILITY FOR OBTAINING WRITTEN INFORMED CONSENT CANNOT BE DELEGATED.
  4. 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.
  5. 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.

  6. 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.
  7. 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.

  8. 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.
  9. 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.
  10. 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 640x480 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