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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 www.uic.edu/com/mrc.

1. Submit the following documentation with an MR Budget Preparation Worksheet to the Grant Administrator -

    A. Title of Project
    B. Name of the Principal and all Key Investigators
    C. Specific Aims with the testable hypothesis
    D. Background (brief but concise)
    E. Preliminary Data (already available, both behavioral and imaging)
    F. Methods: Data analysis and statistics, to include number and duration of MRI examinations with justification. Inclusion and Exclusion criteria must be given
    G. IRB protocol and approval number (state if it has been submitted but pending approval).
    H. Funding agency and the indirect cost rate. If indirect cost is less than the NIH rate, then documentation of the agency indirect rate is required.
    I. Do NOT include a Bibliography.

2. After the Grant Administrator assigns an account number, provide the Clinical Research Coordinator with the IRB approved copy of the Informed Consent Form. This must be done before any subjects will be scheduled unless otherwise authorized by the Director of the Center for MR Research.

3. See General Policy 1 of this manual for scheduling subject

Sponsor: Director
Date: 06/01

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 HMPP TX 2.06 Use and Control of Investigational Drugs).

DEFINITIONS

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.

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.
NOTE: THE RESPONSIBILITY FOR OBTAINING WRITTEN INFORMED CONSENT CANNOT BE DELEGATED.
3. Prior to the collection of any data, discuss the research protocol with the subject. At a minimum, provide the following information to the subject:

a. 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;
b. A description of any reasonably foreseeable risks or discomforts to the subject;
c. 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.
d. A disclosure of appropriate alternative procedures, if any, that might be advantageous to the subject;
e. A statement describing the extent to which the confidentiality of records identifying the subject will be maintained;
f. A statement that the subject's refusal to participate in the research study will not jeopardize the subject's receiving medical treatment at UICMC;
g. A statement that the subject's consent, once given, may be withdrawn at any time;
h. 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;
i. A clarification that costs of treatment (i.e. those entirely outside of the research protocol) are the responsibility of the subject; and
j. A notice of a contact for questions regarding the research protocol and the research subject's rights.

4. 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.

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.

5. 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.

6. 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.

7. 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 (HMPP TX 2.06 Use and Control of Investigational Drugs.)

Sponsor: Director
Date: 8/01

Policy 3: Research Time Billing Procedures


Research scanner time will be billed by the Grant Administrator. 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 number for each study undertaken. This number is used in scheduling scanner time in a minimum of 60 minute increments.
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 report is turned in to the Grant Administrator on a daily basis.
4. The Grant Administrator records the amount of time used by account.
5. The Grant Administrator generates a bill using the departmental accounting system on a monthly basis to each researcher.

Sponsor: Director
Date: 1/02

Policy 4: Billing Procedure for Medications/Drugs Utilized for Research


All medications and drugs utilized in the studies performed on the 3T scanner must be paid for by the researcher whose subject they are used on. Note: Contrast media is billable to the Research Account.

PROCEDURE

1. An accounting of all medications/drugs will be maintained by the Clinical Research Coordinator (See Safety section Policy 9).
2. Drugs/Medications will only be prepared at the time they are to be administered. All drugs and doses will be entered in the research record for the individual subject.
3. For Outpatient research studies, the Clinical Research Coordinator will prepare a prescription form indicating the name of medication, dosage, means of administration, date, patient's name, UIC Medical Record number, and Center for MR Research account number. This will be signed by the Director of the Center for MR Research with his DEA number indicated. The Clinical Research Coordinator will reorder stock supply as necessary. The completed prescription will be given to the Center for MR Research Administrator for billing to the appropriate research account.
4. For Inpatient research studies, the same procedure will be followed as for Outpatient research studies, but a note will be made to the Inpatient medical record by the Clinical Research Coordinator indicating medication (name, dose, route of administration, time of administration).

Sponsor: Director
Date: 2/02

Policy 5: 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:

    a) Get permission from the MR Research Specialist to change settings.

    b) Record these changes immediately in the 3.0T log book.

    c) 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: 5/04
   

Policy 6: 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: 12/05

Policy 7: CMRR Research Contrast Usage Policy


Contrast usage is to be tracked and reimbursements to the Clinical Department for Contrast will be reported on a monthly basis.

PROCEDURE

1. The 3T Technologists (Research Specialists in Health Sciences) should list the unit of dosage of Contrast used for each subject on the day sheets. This should be an amount such as 10, 15, 20, 50, etc.

2. The unit of dosage per subject should be entered into the 3T database by either 3T Technologist. At the beginning of every month, the Contrast usage for the previous month should be printed out and given to the Business Administrator (Assistant to the Director).

3. A copy of the day sheet should be given to the Coordinator of Administrative Services at the end of every working day.

4. The Coordinator of Administrative Services will input the contrast usage amount for each subject from the day sheets as well as other pertinent information into QuickBooks the following day.

5. In the beginning of every month the Business Administrator will generate a report of the dosages of contrast used for the previous month along with the costs. The Business Administrator will send an email to the Assistant Director of Radiology (Sherry Rodgers), Sherry’s administrator, and the Director of the Center for MR Research (Dr. Keith Thulborn) with the quantity and cost of Contrast that we should reimburse the Clinical Department for.

6. The amount of funds withdrawn by the Clinical Department for Contrast should be checked by the Business Administrator when he/she does monthly reconciliation of the accounts.

Sponsor: Director
Date: 3/06

Policy 8: Research Subject Recruiting


All research subjects shall be recruited using only IRB approved documentation and procedures.

PROCEDURE

1) All documents distributed to potential research subjects must have an unexpired IRB approval stamp.

2) All subjects shall be recruited for a study using methods approved by the IRB for that study.

Sponsor: Director
Date: 09/06

Policy 9: 9.4T Scanner Access

It is the policy of the Center for MR Research that all users of the 9.4T MR scanner have approval from the Director prior to use.  Approval is obtained by completing the "9.4T Scanner Authorization" form.  This form is not valid until it is signed by the Director of the CMRR.

Sponsor: Director
Date: 10/09

Policy 10: 9.4T System Monitoring

It is the policy of the Center for MR Research that the 9.4T MR scanner be monitored at all times. Anyone receiving an alarm from the automated monitoring system must respond to it by following the Alarm Response Procedure.  On-site alarm response personnel (OSARP) are on-call 24 hours a day to respond to alarms on-site.  When a member of OSARP cannot be available for an on-site response (e.g., travel), he or she is responsible for making arrangements with the other OSARP members to ensure coverage. These instructions are posted in the CMRR at each alarm response site.

 

Alarm Response Procedure – if you receive an alarm do the following:

 

1)     Log onto http://status94.cmrr.uic.edu to view the current system status.  If you do not know your login credentials send an email to cmrrhelp@uic.edu (It may take up to 72 hours to get login credentials.  If you need these request them NOW, not when there is an alarm).

2)     Report the alarm to the designated CMRR personnel by telephone for on-site alarm response.  If you cannot reach any of the contacts, you must respond to the alarm on-site.

                                    CMRR On-Site Alarm Response Contact Order

1.     Ian Atkinson

2.     Keith Thulborn

3.     Ted Claiborne

4.     Aiming Lu

 

Standard On-Site Alarm Responses - Follow these procedures when responding to an alarm on-site.

 = equipment and action location marked with orange dot.  The 9.4T equipment room (room 1316) has a map of all equipment and zones on the inside of the door.

 

Zone 1: Gradient Coolant Temp (CH-1) or Zone 2: Gradient Amp Coolant Temp (CH-2)

1.     Stop any active scan

2.     Turn off high-voltage to gradient amplifiers (rocker switch labeled turn off switch inside gradient amplifier cabinet  )

3.     Open back of gradient amplifier cabinet to break interlock (  )

4.     Turn off RF amplifiers (two dial switches labeled turn off switch inside RF amplifier cabinet  ) 

5.     Turn off gradient amplifier chiller (CH-1) flow (move lever counter clockwise to flow off  )

6.     Turn off gradient amplifier chiller (CH-1) (rocker switch labeled turn off switch on front panel  )

7.     Turn off gradient coil chiller (CH-2) flow (move lever counter clockwise to flow off  )

8.     Turn off gradient coil chiller (CH-2) (rocker switch labeled turn off switch on front panel  )

9.     Report error to Anchor Mechanical by telephone (contact below)

10.  Report error to Center Director and 9.4T Manager

 

Zone 3: Gradient Coil Temp

1.     Stop any active scan

2.     Turn off high-voltage to gradient amplifiers (rocker switch labeled turn off switch inside gradient amplifier cabinet  )

3.     Open back of gradient amplifier cabinet to break interlock (  )

4.     Turn off RF amplifiers (two dial switches labeled turn off switch inside RF amplifier cabinet  ) 

5.     Report error to Center Director and 9.4T Manager

 

Zone 4: Coolpak Chiller / Water Bypass

1.     Verify coolpak #1 and coolpak #2 are operating (needle should be at position indicated on signs above coolpaks)

2.     Report error to Anchor Mechanical by telephone (contact below)

3.     Report error to Center Director and 9.4T Manager

 

Zone 5: Coolpak # 1 or Zone 6: Coolpak # 2

1.     Press “SELECT” and record the fault displayed on the LCD

2.     Attempt restart failed coolpak by pressing “OFF” and then “ON” buttons on front panel ( • )

3.     Report error to Independence Cryogenic Engineering by telephone (contact below)

4.     Report error to Center Director and 9.4T Manager

Vendor Contacts:

Independence Cryogenic Engineering: Frank Hughes (fhughes@cryopumper.com, 609-294-0012)

Anchor Mechanical: Stefan Noah (smnoah@yahoo.com, 708-870-7605)

 

Sponsor: Director
Date: 2/11, Version: 1.0