Getting Started: User Information

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.

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:

• Language for the eIRB system
• Language for the consent form
• The relevant FDA guidance
• Clinical Engineering Services approval letter

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.

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.

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:

• NBRU Contacts: http://resourcefinder.kennedykrieger.org/nbru/nbru.html
• Application Details: http://www.hopkinsmedicine.org/gcrc/application/process.cfm

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.

As you may be aware, one goal of the Center is to provide state of the art equipment and technology to you. This requires proper maintenance and upgrading of the systems, which is very expensive. When a system has to be replaced, we have been fortunate to obtain NIH funding for that. Specifically, the recent replacement of our first 3 Tesla scanner (MR2) was funded by a high end instrumentation grant from NIH. In line with NIH rules, we now have to acknowledge that award to document the use of this scanner. As you may understand, this is crucial for us to be able to keep getting these grants in the future. So in your papers based on data from the new scanner, can you please add the following acknowledgment. “The MRI equipment in this study was funded by NIH grant 1S10OD021648”. It would be great if you could also add this to the PMC (NIHMS) version of your papers. We apologize for this extra work, but hope you understand the importance of this. Thank you.

The Kirby Center offers intravenous contrast agents (chelated gadolinium) contrast. Pricing is as follows:

• $110 for a single dose (1 vial) and 1 syringe
• $170 for a double dose (2 vials) and 1 syringe
• $190 for a double dose (2 vials) and 2 syringes
• $25 for off-site Creatinine testing.

Please note that, like other Kirby Center procedures, the use of IV contrast must be approved by the IRB.

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 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.