NBRU at KKI

Application Process

How do I access this resource?

To request NBRU research support, the investigator must complete an application and a protocol. Additionally, copies of the IRB/WIRB approved RPN application, protocol and consent forms must be submitted. Please note that even if you wish to access research services from other GCRC units (e.g., laboratory services of the Pediatric Out-Patient Unit), only one application and protocol should be completed and submitted. The GCRC application can be downloaded from the GCRC website:

www.hopkinsmedicine.org/gcrc/

Required Steps

To ensure that the NBRU can meet the research needs of the Principal Investigator, the following steps are required.

To determine feasibility, the principal investigator (PI) must contact the Program Director, Michael F. Cataldo, Ph.D., 443-923-2850, to discuss the proposed project and determine if the NBRU is the best GCRC unit to serve the PI. The PI will be directed to contact the Managers of the following resources as appropriate:

Neurobehavioral Assessment:

· Neuropsychological Testing: Must meet with Mark Mahone, Ph.D., 443-923-4446, mahone@kennedykrieger.org;

· Operant Performance Measures/Customized Assessments: Must meet with either Keith J. Slifer, Ph.D., 443-923-2946 slifer@kennedykrieger.org, or Marilyn Cataldo, M.A., 443-923-2890, cataldom@kennedykrieger.org

Neuroimaging.

· Neuroimaging: F.M. Kirby Research Center for Functional Brain Imaging: Must meet with James Pekar, Ph.D., 443-923-9510, jpekar@kennedykrieger.org.

Protocol Development/Behavior Training:

· Must meet with either Keith J. Slifer, Ph.D., 443-923-2946 slifer@kennedykrieger.org, or Marilyn Cataldo, M.A., 443-923-2890, cataldom@kennedykrieger.org

Biostatistician:

· Must meet with the Biostatistician assigned to the NBRU to review study design and determine appropriate statistical analyses. Confirmation of this meeting by the Biostatistician is a required component of the application packet. Brad Astor, Ph.D., MPH, (410) 502-2779, bastor@jhsph.edu

If your proposed research will utilize services provided by the FM Kirby Research Center, you must follow their Protocol Submission requirements. Go to:

http://mri.kennedykrieger.org

Please note that the FM Kirby Research Center requires submission of: a Resource Utilization Form, an Abstract of Proposed Research, and IRB consent form along with the IRB letter of approval two weeks prior to their Protocol Review Committee meeting.

NBRU Protocol Pre-review Process: To facilitate the review process, the NBRU suggests that the PI submit an administrative draft of their application (with required components) and the IRB approved protocol, one week prior to submission to KKI, 2nd floor, Room 200-J. This draft will be reviewed by NBRU administrative staff before the formal submission of the protocol. The PI can expect to hear of any potential problems or missing components within two days of their draft submission.

The NBRU offers this pre-review in an effort to ensure the completeness of the protocol and timely review by their PRS. Incomplete protocols often postpone the PRS review process for one or more months.

The completed application (with 26 copies) should be submitted to the NBRU offices, located in Room 200-J of the Kennedy Krieger Institute.

· GCRC application, protocol summary and human subjects section (hardcopy and on diskette or by e-mail attachment).

· IRB stamped consent/assent forms (hardcopy and on diskette or e-mail attachment)

· IRB letter of approval

· Certification Letter from the FM Kirby Research Center PRC (if applicable)

· Certification Letter from the Neuropsychological Testing Center (if applicable)

· Confirming correspondence/e-mail from Neurobehavioral Consult (if applicable)

· Confirming correspondence/e-mail from the Biostatistician as to the review of research design

Please submit one copy of the IRB Human Subjects Training Certificate of Completion and HIPAA Certification for each of the investigators listed on the protocol.

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