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-owned or managed data. We also provide assistance to investigators throughout the protocol development
and submission processes.
NOTE: If your protocol involves the use of TMA owned or managed data, then you may need to obtain a formal
agreement with TMA for the sharing and use of those data elements. The 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.
