NOTE : As of 4/25/16, the Electronic Institutional Review Board (EIRB) system is live.  At this time, all documentation (new studies, amendments, continuing reviews, etc.) should be submitted through the EIRB.  >>Learn More

The Department of Defense (DoD), Office of the Assistant Secretary of Defense for Health Affairs (OASD[HA]) and the Defense Health Agency (DHA) 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 volunteer subjects who participate in the studies.

This page describes the implementation of the Human Research Protection Program within OASD(HA) and DHA.

The overarching Regulation governing the Protection of Human Subjects in federally-funded research is referred to as the “Common Rule,” because most Federal Departments and Agencies that support human subject research, including the DoD, have adopted this regulatory framework.  The DoD adopted the Common Rule through Part 219 of Title 32 of the Code of Federal Regulation (32 CFR 219).  Within the DoD, that Regulation is implemented by DoD Instruction (DoDI) 3216.02 (“Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research”).

The foundation of HRPP compliance review is the Institutional Review Board (IRB). Neither OASD(HA) nor DHA Headquarters (HQ) has an IRB.  Non-exempt studies that originate within OASD(HA) or DHA (excluding the National Capital Region Medical Directorate institutions) are, by agreement, reviewed by the U.S. Army Medical Research and Materiel Command IRB at Fort Detrick. 

Our office provides the following review services when OASD(HA), DHA, or other component activities will require access to DHA data:

• Human Subject Research Determination
• Exempt Determination
• Human Research Protection Official’s (HRPO) Review
• Protocol Modification Review
• Continuing Review
• We also provide assistance to investigators throughout the protocol development and submission processes

NOTE : If your protocol involves the use of DHA data, then you may need to obtain a formal agreement with DHA for the sharing and use of those data elements.  The DHA Privacy and Civil Liberties Office manages the Data Sharing Agreement (DSA) program.  Information and instructions for executing a DSA may be found on the Submit a Data Sharing Application page.