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Frederic C. Bartter
General Clinical Research Center (GCRC)

 

Research Imaging Core Information for PIs

 

 

All protocols considered for use of GCRC Imaging Core must be discussed with a Research Imaging Center faculty member who is knowledgeable in the field(s) related to your research.  The faculty member will help determine the feasibility of the protocol, the experimental design and optimal use of the equipment, and the proper data analysis methods and will assist in the review process.  Protocols will be submitted to the GCRC Imaging Core Administrator (Jean Hardies, Ph.D., 567-8181).  We strongly encourage electronic submission of protocols and forms.

Submission Requirements

Protocols to be reviewed by the GCRC Imaging Core must be received by the first Wednesday of the month.  Meetings are held on the third Wednesday.  The protocol does not have to have IRB approval prior to submission to the Imaging Core, however it must have IRB approval prior to scheduling subjects.  Please provide: 

  1. GCRC-IC forms
  2. RIC Utilization Review Committee (URC) forms (if the proposal has prior URC approval, so indicate on the GCRC-IC forms)
  3. The complete IRB submission:
    1. For eIRB submissions: the entire eIRB application and attachments, including the protocol (and any grant/addendum) and  consent form(s)
    2. For non-eIRB submissions: the protocol (and any grant/addendum), all IRB forms (Application page, Data Sheet, Table of Contents, Radiation Worksheets) and consent form(s)
  4. If GCRC-IC funds are requested, a discussion of why funds are needed, i.e. pilot funds, matching funds (see #5), etc.
  5. If the project has funding from another source, specify the part(s) of the proposal for which GCRC-IC matching funds are requested (i.e. additional subjects, additional fMRI sequence(s) not funded by a grant, etc.)
  6. Discussion of how GCRC-IC funds will lead to future grant submissions
  7. Once IRB-approved, a copy of the IRB approval letter and the IRB-stamped consent form(s)
  8. A short summary/abstract of the protocol to be placed on the GCRC-IC agenda.

Forms should be filled out by the PI.  Imaging Core faculty will provide assistance as needed.

GCRC-IC Review

The PI will be expected to attend the GCRC-IC meeting where the proposal is reviewed to present the proposal and answer the Committee’s questions.  (This requirement can be waived if the investigator has previously presented the proposal at a meeting of the RIC Utilization Review Committee and there have been no substantial changes to the proposal since that review.)  The Committee will approve with funding, approve without funding, approve with stipulations, disapprove or table the protocol. 

If the protocol is approved, the committee will determine the protocol’s scheduling priority.  Each member of the committee will score the proposal from 1 (highest) to 5 (lowest). Scheduling priority is decided based on the type of study, critical need of the images, and inconvenience of delay or rescheduling of the study subject, principal investigator, and imaging staff.  Generally, clinical studies are awarded a priority of 1 and research studies with normal controls are given a priority of 2 or lower.  Research studies with PIs from other cities, states or countries will be given Priority 1.  The final score will be the average of the voting members of the GCRC Imaging Core Committee. Committee members may abstain from this process.

The Committee will communicate the decision to the principal investigator in writing or by email.

Approved protocols can be activated when the Administrator receives an IRB/eIRB approval letter and stamped consent form(s).

Progress Reports

The principal investigator of an approved project should submit to the GCRC-IC Administrator:

  1. A copy of the annual IRB continuing review and IRB re-approval each year that a protocol is active in the GCRC-IC;
  2. A short summary of research progress since GCRC-IC approval or since the last IRB re-approval was submitted, including # of scans completed and remaining, outside funding status (if applicable), and anticipated completion of project;
  3. All protocol amendments and consent form changes when they are approved by the IRB.

All publications and abstracts that allow acknowledgments and that utilize GCRC-IC funds or other resources must cite the GCRC-Imaging Core in acknowledgments:  “This research was funded by the NIH General Clinical Research Center – Imaging Core, grant M01-RR-01346.”

The GCRC guidelines for protocol submission (non-Imaging Core protocols) can be found here.

 

        GCRC Research Imaging Core Directors
        Research Imaging Core Home
        Research Imaging Core Staff Chart

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                        Date page last modified:  05/11/06 12:34 PM