DOD and VA IRB Information

An institutional review board (IRB), also known as an independent ethics committee or ethical review board, is a committee that has been formally designated to approve, monitor and review biomedical and behavioral research involving humans with the aim to uphold a code of ethics to protect the rights and welfare of the research participants. In the U.S., regulations introduced by the Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS), as well as the Food and Drug Administration, have empowered IRBs to oversee research by approving, requiring modifications in planned research prior to approval, or denying, proposed studies/projects. Each IRB performs critical oversight functions for research conducted on human participants to ensure they are scientific, ethical and regulatory.

The Federalwide Assurance (FWA) is the only type of assurance currently accepted and approved by OHRP. Through the FWA, an institution commits to HHS that it will comply with the requirements in the HHS Protection of Human Subjects regulations as stated within the 45 CFR part 46. In addition to securing an FWA, service-specific addendums may be required.

As of now, each research facility must have its individual research projects approved through its own particular IRB mechanism, which presents a challenge to joint collaborative research. Each service, as well as the VA, has a slightly different review process. The necessity to obtain approval at multiple sites is cumbersome and results in duplication of efforts and unnessary inefficiencies. The HCE is currently pursuing the establishment of a centralized IRB to lead the review of all hearing and balance-related protocols within the Department of Defense.

Search for a specific IRB by organization, IRB or FWA.

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