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TRICARE Management Activity (TMA) Human Research Protection Program for the Office of the Assistant Secretary of Defense (Health Affairs)

The Department of Defense (DoD), Office of the Assistant Secretary of Defense (Health Affairs) (OASD[HA]) and the TRICARE Management Activity (TMA) support and encourage research, including human subject research. All research protocols that include human subjects must be compliant with Federal laws, Federal Regulations and DoD policies intended to protect the subjects of the studies. To ensure compliance within the Military Health System (MHS), an integrated protocol review process has been established that is managed by the Research Regulatory Oversight Office in the Office of the Assistant Secretary of Defense (Force Health Protection and Readiness). This page describes the implementation of the Human Research Protection Program (HRPP) within OASD(HA) and TMA.

The overarching Regulation governing the protection of human subjects of research is often referred to as “The Common Rule” since it has been adopted by most Federal Departments and Agencies in which Federally-funded/supported human subject research is conducted or supported. For the Department of Defense, The Common Rule Regulation is found in 32 CFR 219 (Protection of Human Subjects). Within the DoD, that Regulation is implemented by DoDI 3216.02 (Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research).

The foundation of compliance review is the Institutional Review Board (IRB). Neither OASD(HA) nor TMA has constituted an IRB. Non-exempt studies that originate within OASD(HA) or TMA are, by agreement, reviewed by the U.S. Army Medical Research and Materiel Command IRB at Fort Detrick. Our office provides Exempt Determination, Human Research Protection Official's (HRPO) Review (formerly known as a "Secondary Review"), Continuing Review and Protocol Modification Review services in support of OASD(HA), TMA or other component activities that will require access to TMA managed data. We also provide assistance to investigators throughout the protocol development and submission processes.

NOTE: If your protocol involves the use of TMA managed data, then you may need to obtain a formal agreement with TMA for the sharing and use of those data elements. TMA Privacy and Civil Liberties Office manages the data sharing agreement program. Information and instructions for executing a data sharing agreement may be found on the Data Sharing Agreement page. A prerequisite for obtaining a data sharing agreement with TMA is a HRPO review or exempt determination from the TMA Human Research Protection Program Office. The Guide for DoD Researchers on Using MHS Data is a guide for Department of Defense (DoD) researchers who plan to request Military Health System (MHS) data for research purposes. For further information click on Guide for DoD Researchers on Using MHS Data here.

“On October 1, 2013, the Department of Defense established the Defense Health Agency (DHA) to manage the activities of the Military Health System. These activities include those previously managed by TRICARE Management Activity (TMA), which was disestablished on the same date. During the next several months, all TMA websites will change to reflect the new DHA. We appreciate your patience during this transition."
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