The Georgetown IRB reviews research involving human subjects via full board review procedures, expedited review procedures, or exempt determinations. Any non-exempt human subjects research must be reviewed and approved by the IRB prior to any intervention or interaction with human subjects, including recruitment procedures.
IRB Committees: Georgetown IRB has four IRB committees; each committee is composed of members from both scientific and non-scientific backgrounds. Membership includes faculty and staff from both GU and MedStar, as well as representatives from the local community. Information regarding each committee, including rosters and schedule can be found under each committee noted in the dropdown menu below.
Schedule: The schedule applies to submissions requiring review at a convened IRB meeting (full board review). Submissions that may be eligible for expedited review, exempt review, or non-human subject research determinations are reviewed on a rolling basis upon submission of all necessary materials and are not required to meet submissions deadlines for review by the convened IRB (full board review).
Deadlines: Deadlines for IRB Committee Meetings are on the same day of the week as the committee meeting and fall three weeks prior to the scheduled meeting date. Any applications that you believe may require review at a full board meeting must be submitted by the meeting’s corresponding deadline to be considered for inclusion on the meeting agenda. Due to holidays or the academic calendar not all meetings follow the regular schedule, location and/or time and are marked by an asterisk ( * ) in the meeting calendar.
The Institutional Review Board for biomedical research (Committee AB) has the responsibility of reviewing proposed research projects to ensure that the rights, privacy, and welfare of all human subjects, who participate in research studies conducted by Georgetown, are adequately protected. This biomedical committee is a combined committee of Committee A and Committee B. All studies that were previously reviewed and approved by Committee A or Committee B will now be reviewed and approved by this combined committee. In compliance with Federal law and institutional policy, all research projects involving human subjects or human material must be reviewed and approved by the IRB. All biomedical research projects conducted by the faculty, the staff and students of the University are subject to the Policies and Procedures of the Institutional Review Board.
Biomedical research involves research (i) to increase scientific understanding about normal or abnormal physiology, disease states, or development; and (ii) to evaluate the safety, effectiveness or usefulness of a medical product, procedure, or intervention.
The OHRP IRB number for Committee AB is IRB00012691.
The Institutional Review Board for social and behavioral science research involving human subjects (Committee C) has the responsibility of reviewing proposed research projects to ensure that the privacy and welfare of the research participants are adequately protected. All faculty and students engaged in such research should submit requests for IRB approval prior to beginning their work. This requirement applies to all such research, regardless of the source of support. Faculty at the Georgetown University Medical Center who are conducting social and behavioral research should make their submissions to this body.
The Social and Behavioral Sciences Institutional Review Board is composed of faculty affiliated with the variety of social science disciplines at Georgetown. It also includes representatives from the community. A full membership roster is available at IRB-C Board Members page.
Much of the research done in the social and behavioral sciences may fall into one or more of the categories for exemption. Exempt determinations are made by the IRB.
The OHRP IRB number for Committee C is IRB00002118.
On January 29, 2002 Georgetown University and MedStar Health, Inc. entered into a Memorandum of Understanding, to organize and operate the MedStar Health Research Institute-Georgetown University Oncology Institutional Review Board (MHRI-GU Oncology IRB). The President of the MedStar Health Research Institute (MHRI) and the Executive Vice President for Health Sciences at Georgetown University agreed that employees of Georgetown University would administer the Institutional Review Board. The MHRI-GU Oncology IRB will have jurisdiction over new Oncology human subject research protocols done at Georgetown University and/or any MedStar Health, Inc. healthcare facility (Franklin Square Hospital Center, Union Memorial Hospital Center, Harbor Hospital Center, Good Samaritan, National Rehabilitation Center, Harborview Cancer Center, Washington Cancer Institute and Washington Hospital Center), as of April 17, 2002, and will assume jurisdiction over ongoing previously approved studies at the time of annual review.
The OHRP IRB number for Committee D is IRB00002119.
The Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS) Institutional Review Board is the IRB for the GHUCCTS consortium; its purpose is to review consortium research studies. Members of the GHUCCTS IRB Committee are appointed by each participating institution. This multi-institutional IRB allows for efficient study implementation at any or all of the GHUCCTS CRUs. The GHUCCTS IRB coordinates their review process for GHUCCTS protocols involving the participation of investigators and patients from the GHUCCTS clinical institutions.
The GHUCCTS IRB reviews all studies that are:
GHUCCTS-funded and/or;
Will be utilizing more than one GHUCCTS’ institution.
The following additional studies are also eligible for review by the GHUCCTS IRB:
Research studies that will utilize GHUCCTS facilities
Please note that SEPCOM review MUST OCCUR PRIOR to the GHUCCTS IRB review. For more information regarding the SEPCOM-GHUCCTS IRB Review Process, please see the SEPCOM – GHUCCTS IRB Review Summary Guide.
The following are resources and related links for information and resources regarding GHUCCTS program and SEPCOM review: