Georgetown Research Services
Georgetown Research Services

Institutional Review Board

On behalf of Georgetown University, the Institutional Review Board’s (IRB) primary role is to safeguard the rights and welfare of all human subjects who participate in research studies conducted by Georgetown. 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, social and behavioral 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.

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Compliance Statement and FWA

Georgetown University (GU) IRBs are guided by the ethical principles in the Belmont Report and its Federalwide Assurance (FWA). 

The GU IRBs operate in accordance with applicable laws, regulations, and guidance in the United States (U.S.) and other countries, including but not limited to, the U.S. Department of Health and Human Services (DHHS),45 CFR 46, (Common Rule) and U.S. Food and Drug Administration (FDA),21 CFR 50 and 56. All human subjects research conducted or supported by DHHS, or other U.S. federal agencies that have adopted the Common Rule, will comply with all subparts at 45 CFR 46 (Subparts A, B, C, D, E). 

The GU will ensure that its organizations and investigators engaged in its U.S. federally supported human subjects research will operate under an appropriate OHRP (Office for Human Research Protections) or other federally-approved Assurance for the protection of human subjects. Independent investigators who are not employees or agents of GU may be covered under the GU’s FWA, at the discretion of the institution, only in accordance with a formal, written agreement of commitment to relevant human subject protection policies and GU IRB oversight. 

All of GU IRBs are registered with OHRP and its FWA is approved by OHRP. The GU FWA information can be found below and on the OHRP website.

The expiration date for this assurance changes frequently. If you need the expiration date, please visit OHRP’s Database for Registered IORGs & IRBs Approved FWAs, enter the FWA Number above, and click “Search.”

A downloadable version of this Compliance Statement is also available.