New Trial Start-Up: How you use the Institutional Review Board office

Review of your protocol by the Iinstitutional Review Board requires that you:

1. Complete the IRB application.
   
2. Generate an informed consent which is consistent with the guidelines of both the study sponsor and the Georgetown IRB. If you intend to enroll ONLY at GUH, use the GU consent form as a template. If you also intend to enroll at other MedStar facilities, use the MedStar-GU joint consent form. (The IRB office has template informed consents that you can use which contain key information required for any approved informed consent used at Georgetown.)
   
3. Provide 22 copies of the application and 3 copies of the sponsor supplied protocol and one copy of the Investigator brochure.

Georgetown University currently has four IRB's. Two of the four IRB's review non oncology clinical trials, the third is a joint IRB (with MedStar Research Institute) to review oncology trials. Finally, the fourth IRB reviews social behavioral trials.

Note that the IRB application must be submitted no later than the Friday two weeks prior to the date of each IRB meeting. See the IRB website for information about their meeting schedule.

Your grant will be billed a one-time fee of $1500 for any full IRB review of a new trial application.

IRB contact information
Associate Director of Research Assurance and Compliance
Laura Miller: phone 784-5367, email cm26@georgetown.edu

GU IRB Coordinators
Daniela Radu: phone 687-6553, email dr72@georgetown.edu
Serena Artis: phone 687-1506, email artiss@georgetown.edu
Alex Mihai: phone 687-1928, email mihai@georgetown.edu

Joint GU/MRI Oncology IRB Coordinator
Daniela Radu

IRB Office Fax: 202-687-4847