F. M. Kirby Research Center for Functional Brain Imaging
At the Kennedy Krieger Institute

Getting Started: User Information

This information is for investigators who are interested in utilizing the many resources that the F. M. Kirby Center has to offer. Specifically:
Image from DTI of the Human Brain

A portion of the database for white matter in the human brain.

Integrating the Kirby Center with the JHM eIRB

The Kirby Center review is integrated with the JHM eIRB!

All Kirby Center studies require advance approval by the appropriate IRB(s). All applications must be submitted via the Johns Hopkins Medicine IRB electronic IRB (eIRB) system.

Please note that, when submitting your protocol via the JHM eIRB system, it is essential that you list the Kirby Center as a performance site. This will enable the eIRB system to capture Kirby Center specific information, and to automatically route your proposal for review, as follows:

  1. The Protocol Review Committee (PRC) of the Kirby Center (for scientific review);
  2. The Kennedy Krieger Institute (KKI) (for risk/safety review);
  3. JHM-IRB.
[Note that the Johns Hopkins Medicine IRB requires KKI administrative endorsement of all proposals to conduct human subjects research at KKI, including Kirby Center projects by non-KKI principal investigators. KKI has chosen to so endorse only those proposals that have been approved by the PRC. The result of this is that new projects must be approved by the PRC before KKI will endorse them to the JHM IRB.]

In exceptional cases, the PRC may consider formal written requests for no more than five hours of "pilot" time. Such a request should state that no other funds are available to support the scanning, and should lay out plans to secure funding for further work.

Please note that our 3T scanners are FDA-approved medical devices; the approval documentation is available online (.pdf). Please be sure to use the "MRI language" mandated by the JHM IRB, in your consent form.

7.0 Tesla at The F. M. Kirby Research Center for Functional Brain Imaging

In April of 2009, the Kirby Center obtained a 7.0 Tesla human MRI scanner available for your use. This system represents a unique opportunity in neuroscience research within the Johns Hopkins community. The 7T comes with a 32-channel coil, and is equipped with fMRI presentation setup.

At this time, we would like users to consider expanding their existing protocols to add the possibility of scanning at 7T. This can be done with an amendment letter to the IRB. As a resource to help you make this request, we provide links to: Note that the 7T supports:
  • Multi-frequency transmit and receive
  • Other coils:
    • Cervical spine 1H coil (8-channel)
    • 13C/1H loop coil (leg)
    • 31P/1H head coil
  • Interface boxes for home-built coils
Please do not hesitate to contact us with any questions.

Applying for Grant Funding to Use The Kirby Center

Every new (and competitive renewal) federal grant application for Kirby Center scanning needs to include a subcontract to Kennedy Krieger Institute to ensure that KKI recovers the appropriate indirect costs for the magnetic resonance scanning.

Please note that addition of a subcontract will not change your direct costs (DC)! Even though consortium costs (DC + indirect costs (IDC)) are displayed as direct costs in your grant, the total allowed DC can be increased by the amount of consortium IDC, so that you can still keep the maximum DC. This applies to all NIH grants, including modular budgets. If you have questions about this, please contact Jackie Pittman.

We would be happy to develop a subcontract for you. To do so, we need the following information:
  1. Name and department of principal investigator
  2. Grant title
  3. In response to RFA? If so: number, name, and date
  4. Grant dates: years, start date, end date
  5. IRB protocol: name, principal investigator, number, effective date
  6. For each grant year, please specify the number of hours of use for each scanner
  7. Any KKI salary support (optional)
  8. Brief summary of grant (for KKI review; one paragraph is fine)
Please note that subcontracts require review by KKI, and that KKI requires five days (prior to the JHU internal deadline) for this review.

Local Resources for Funding Patient Research Pilot Scans (NBRU/GCRC/ICTR)

The neurobehavioral research unit (NBRU) is part of the ICTR (previous GCRC) and can provide pilot funding for MRI data acquisition and data processing.

Websites:

Rates for Kirby Center Scanning. . .

When applying for grants, please use the below rate* table. These rates reflect a fair estimate of inflation. As such, they are subject to change, but changes need to be approved by the Protocol Review Committee (PRC). Please notice that for existing subcontracts with older rates, the Kirby Center will apply the rates according to the table. However, if the investigator depletes all funds designated in the existing subcontract, a request to fund the remainder of the study can be made to the PRC.

Calendar Year 3T per hour 7T per hour
2009 $600 $750
2010 $615 $765
2011 $630 $780
2012 $630 $780
2013 $630 $780
2014 $630 $780
2015 $645 $795
2016 $645 $795
2017 $660 $810
2018 $675 $825
2019 $690 $840
2020 $705 $855
2021 $720 $870
2022 $735 $885
2023 $750 $900

* Special rates are available for pre-reserved slots (these need to be requested from the PRC, and prepaid). Also, development time (pulse sequences and other technology implementation) is 1/2 the rate.

Radiological Readings of Images

The JHM-IRB is developing a new policy to require that if a research procedure generates images which are of clinical quality, then the images are to be reviewed by an an individual who, by virtue of their hospital delineation of privileges, is credentailed to read such examinations. It therefore behooves all researchers, who are not credentialed to read such cases, to enroll a radiologist to participate in their research project in this way.

As to funding, this is to be determined between radiologists and researchers. The Department of Radiology has agreed to perform such reading whether or not the PI has funding for such for ongoing projects, with the understanding that any new projects will include budgeting of funds to support such reading. The Medicare fee schedule for Professional fee to read an MR Head study (without contrast) is $77 per case. This can be used as a baseline for grant submission. Alternatively, a percent effort can be computed by factoring 20 minutes per case, divided by 40 hours a week X 40 weeks on clinical = 1600 hours as the denominator, to yield percent effort. Example: 200 cases X 0.33 hours = 67 hours divided by 1600 hours = 4.2% effort.

KKI Guidelines for Research Projects involving Urine Pregnancy Testing

In Fall of 2009, KKI received clarification regarding urine pregnancy testing within human subjects research projects, which was verified with the State of Maryland Laboratory Administration. If the results of a urine pregnancy testing are being used for screening for study inclusion, the testing must be performed under a CLIA (Clinical Laboratory Improvement Amendments) license, even if the research team does not share the results with the participant.

From this point forward, based on these CLIA requirements, research applications that include pregnancy testing procedures require either: (1) urine pregnancy testing using a CLIA certified laboratory such as the Johns Hopkins Medicine (JHM) Pathology lab, or (2) waived/point-of-care urine pregnancy testing in an institution with a CLIA license. The Kennedy Krieger Institute does not have a CLIA license for waived/point-of-care urine pregnancy testing. Waived testing for KKI protocols may be done at one of the JHH clinical research units (adult or pediatric, in-patient or out-patient). For more information on the Johns Hopkins Clinical Research Unit services and application process, please go to http://www.hopkinsmedicine.org/gcrc/.

The JHM pathology lab offers specimen processing and diagnostic testing at a reduced price for research studies. Research discounted pricing applicable to a study account in Pathology can be obtained by sending a list of required study tests to bfilburn@jhmi.edu (phone 410-955-2661, fax 410-955-5961) or to jnash1@jhmi.edu (phone 410-287-5197, fax 410-955-0394).

Using the JHM Pathology lab will require the research participant to have or register for a JHH medical record number. Some research participants who live in this area may already have a JHH number. For KKI research participants who are not clinical patients and require lab testing, the study team should call ahead of the scheduled study visit and request a JHH number for a research participant. The KKI person to call to request a JHH number is Debbie Simpson at (443) 923-2613. The JHH office number is (410) 955-6262. The required information includes: patient complete name, DOB, home address, mother's maiden name, and social security number. JHH may require additional information. Having the information ready at the time of the request will expedite the process.

If You are a Funded Investigator Who Wants to Extend Your Research to Neuroimaging. . .

If you are a funded investigator who wants to extend your research into the field of neuroimaging, and you need help conceptualizing, planning, or implementing your experiments, please feel free to contact Dr. Mike Kraut, head of the Neuroimaging Core of the Intellectual Developmental Disabilities Research Center (IDDRC) at the Kennedy Krieger Institute. Under the auspices of the IDDRC, you will find faculty with expertise in anatomic, spectroscopic, and functional neuroimaging. Mike will talk with you about your plans, and direct you to the person who will likely be of the most help. Mike Kraut can be reached at (410) 955-6593 (office), or by email at mkraut1 at jhmi dot edu.

The above information was provided by Dr. James Pekar.