SOP109: Approval for BIAC Scanner Use

Summary

This SOP establishes a policy for the submission and review of protocols that utilize the BIAC scanners.

Scope

These policies apply to all Duke and UNC investigators who wish to conduct scientific studies that utilize the BIAC MRI scanners.

Definitions

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

• Experimenter - The investigator, research assistant, or MRI operator who is responsible for the subject and conducting the experiment.

Policies and Procedures

1. Overview:

   Because of heavy user demand, experimental time on BIAC's MRI systems is limited. A scientific review committee composed of BIAC faculty and affiliated investigators will therefore review research proposals and award magnet time on a priority basis. All investigators, including core BIAC faculty and post-doctoral fellows, must submit research proposals to obtain access to the scanners.

   New PIs are encouraged to discuss their planned use of the scanners with the BIAC Director prior to submitting a protocol for scientific review. As noted below, PIs must discuss their planned use of BIAC facilities before submitting grants that depend upon their access to these facilities. PIs should note that BIAC is under no obligation to provide scanner time to funded projects that have not been submitted for scientific review.

2. Eligibility:

   Investigators at Duke University and the University of North Carolina at Chapel Hill may apply for scanner time to conduct experimental studies at the BIAC.

3. Review Criteria:

   The review criteria include scientific merit and significance, technical feasibility, relevance to the BIAC mission, and funding status.

4. Funding:

   The BIAC receives no annual operating stipend, and thus must recover all of its operating expenses from grants and hourly scan charges. The current charge for all NIH, NIMH, CDC, and NSF grants is $640/hr. This charge includes technician time, but it does not include data analysis, filming, clinical diagnostic film review, training costs, or sedation. The BIAC reserves the right to modify the hourly scan rate based upon changes in usage patterns.

   Federal regulations require that no other non-federal agency, company, or group can receive a lower scan charge than that specified in federal grants. However, BIAC typically charges a higher hourly scan rate for industry-sponsored grants and contracts. PIs contemplating the submission of a non-federally funded grant or contract, such as that submitted to a pharmaceutical company, must discuss scan charges with the BIAC Director in advance of submission.

   Because imaging hours are finite, all PIs must discuss their intended use of BIAC scanners with the BIAC Director prior to grant submission.

5. BIAC-sponsored studies:

   Scan charges apply to all studies. However, the BIAC may subsidize the scan charges incurred for otherwise unfunded projects provided that (1) the project is particularly relevant to the BIAC mission, and (2) there is a reasonable chance that the successful completion of the project will lead to future funding for the PI. The BIAC strongly encourages a PI to present their pilot results to the BIAC User Group meeting. Submission of pilot results is a precondition for a PI to obtain additional BIAC sponsored hours for their project.

   The BIAC also subsidizes internal projects that are designed to improve BIAC's technical capabilities or that contribute to BIAC's educational training mission.

6. IRB or IACUC Approval:

   A protocol may be submitted to BIAC for scientific review while IRB or IACUC approval is still pending. However, an investigator will not be able to schedule time on the web-based scanner schedule until BIAC has received proof of IRB or IACUC final approval. The time-stamped approval form should be emailed or faxed to the BIAC office.

   The scheduling program checks a database for IRB and IACUC expiration dates and automatically disables further scheduling unless a renewal approval has been received at the BIAC office.

   UNC PIs should note that IRB or IACUC approval will be required from both Duke and UNC prior to scheduling.

7. Frequency of meetings for the BIAC Scientific Review Committee:

   At present, the review committee meets on Monday at noon following the BIAC User Group meetings. The meeting frequency has been determined by the number of protocols received. A PI should expect a review within one month's time.

8. Expedited reviews:

   Under extraordinary circumstances, the Chairman of the Scientific Review Committee can expedite a review to permit the expeditious acquisition of data. For example, this might occur for a protocol that depends upon recruiting rare patient types, or when pilot data is required to support a letter of intent or RFA with a short deadline. A protocol that lacks IRB or IACUC approval can never be expedited.

9. Review feedback:

   A letter summarizing the review will be sent to the PI via email. Protocols may be approved, approved with minor modifications, deferred for additional information, or disapproved. In some instances, the Scientific Review Committee may invite the PI to the review session for clarification of the protocol.

   PIs who attend the review meeting to help clarify their projects for the committee must leave the room prior to the vote. This rule also applies to PIs who are committee members.

10. Appeals:

    PIs who believe that their protocols did not receive a fair review can appeal to the BIAC Director, or to the BIAC Administrative Oversight Committee.

11. Format of application (2-3 pages maximum):

    The following headings must be used in preparing the protocol. The PI should email the completed protocol to the BIAC Scientific Review Committee. See proposal template and example proposal.

    1. Title of Proposal
    2. Principal Investigator and Department
    3. Faculty Sponsor
    4. Responsible Investigator
    5. Other Investigator(s)
    6. Contact Information
    7. Experimenter(s)
    8. Scheduler(s)
    9. Person(s) with data access
    10. Data Analysis
    11. Scanner Required
    12. Funding Source
    13. IRB Registry number and approval date
    14. Length and Number of requested imaging Slots
    15. MRI Technologist Required (Yes or No)
    16. BIAC disk needed (Yes or No)
    17. Other special requirements (e.g. scheduling, special equipment, etc.)
    18. Description (Short Synopsis of Study)
        • Rationale and Scientific Significance
        • Experimental Design
        • Imaging Protocol
        • Data Analysis
    19. If animal study, method for disinfecting scanner after use
    20. Suggested Experiment ID (e.g. Memory.01)

12. Following approval:

    Once a protocol is approved, a PI will be provided with a protocol name (e.g., Memory.01). This name will appear on the protocol list when the PI accesses the BIAC Web calendar and must be used to schedule all Subjects under this approved protocol. Scheduling can commence once this protocol name has been assigned and an IRB or IACUC final approval form has been received.

    PIs who require a BIAC computer account, an electronic key to the BIAC facilities, or who have problems in accessing the BIAC calendar should contact the BIAC Help Desk.

    PIs should note that safety training is required for all individuals from the PI's group who require entry into the MRI suite. Please refer to Research Safety for instructions.

13. Renewals:

    Approval is for a one-year period. A renewal application must be submitted by those PIs who wish to keep there protocols active. The format of the renewal application is similar to the initial submission, except that the Description section should focus on describing the previous year's scanner usage and results, and any changes in the experiment proposed for the upcoming year.

14. BIAC User's Meeting:

    It is highly recommended that investigators attend the BIAC User Group (BUG) meetings when they are announced. These meetings provide investigators a forum to present new proposals and to review preliminary results and completed studies. The BIAC faculty, post-docs, students, and staff provide helpful criticism and insights. The meetings are also used to provide updates concerning technical and other relevant developments. Anyone interested in being added to the electronic mailing list for these meetings should contact the BIAC office.