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Research Protections

The Department of Defense (DoD) and the Defense Health Agency (DHA) support and encourage research, including human subjects 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 (HRPP) within DHA.  If you have questions, then please contact us at DHA.HRPP@mail.mil.

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 subjects 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”).

If your protocol involves U.S. Food and Drug Administration (FDA)-regulated activities, then it must comply with the FDA’s regulations regarding:

The DHA Office of Research Protections (ORP) is the Human Research Protections Program for the DHA Headquarters (HQ). The foundation of HRPP compliance review is the Institutional Review Board (IRB).  However, the DHA does not have an IRB.  Within the DHA, the Walter Reed National Military Medical Center (WRNMMC) maintains an IRB with multiple panels, so non-exempt studies that originate within DHA are reviewed by those IRBs. In addition, DHA institutions that do not have a designated IRB of record will have their non-exempt studies reviewed by the WRNMMC IRB.

Please visit the DHA ORP milSuite page for guidance, instructions, training and important points of contact.

Many studies do not require IRB review.  In those cases, our office provides the following review and consultative services: 

NOTE: All documents for review must be submitted using the Electronic Institutional Review Board (EIRB). Information on accessing the EIRB system and submitting documents for review can be found by following the link above.

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.  This approval is separate from DHA ORP approval.

If your protocol involves the use of surveys, you must contact the DHA Information Management Control Officer (IMCO) regarding requirements for obtaining approval: (703) 681-3636 or e-mail dha.ncr.j-5.list.ae-list-a-e-imco@mail.mil.  This approval is separate from DHA ORP approval.

Please visit the DHA ORP milSuite page for guidance, instructions, training and important points of contact.

DHA Address: 7700 Arlington Boulevard | Suite 5101 | Falls Church, VA | 22042-5101

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