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Institutional Review Board (IRB) Information

If you are pursuing a multi-site auditory or vestibular protocol within the DoD, please contact the HCE to determine the most efficient strategy for regulatory approval.

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 that were introduced by the Office for Human Research Protections (OHRP), the Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA) have empowered IRBs to: 1) approve, 2) require modifications in planned research prior to approval, or 3) deny proposed studies/projects. Each IRB performs critical oversight functions for studies involving human participants to ensure the research is scientific, ethical, and legal.

The Federal-Wide Assurance (FWA) is the only type of assurance currently accepted and approved by the 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 in the 45 CFR part 46. In addition to securing an FWA, DoD and/or Service-specific addendums may be required.

Each research project conducted within the DoD must be approved through the IRB of engaged institutions, often requiring multiple approvals. This 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 unnecessary inefficiencies. To overcome many of these challenges, the HCE has established an agreement with the US Army Medical Research and Materiel Command (USAMRMC) IRB Office to perform as a centralized IRB to lead review of all hearing and balance-related protocols within the DoD.

The VA also has a centralized IRB system. More information about the DoD and the VA IRB processes, and where to begin working through them, can be found in the VA/DoD Collaboration Guidebook for Healthcare Research.

You can also search for a specific IRB by organization, IRB or FWA.

About Us

The Hearing Center of Excellence fosters and promotes the prevention, diagnosis, mitigation, treatment, rehabilitation and research of hearing loss and auditory injury. It supports the development, exchange and adoption of best practices, research, measures of effectiveness and clinical care guidelines to reduce the prevalence and cost of hearing loss and tinnitus among Warriors and Veterans. Read more

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