Establishing a human research protection program in a combatant command.

Extensive United States combat operations commenced for the first time in over decade in 2003. Early in 2004 there was no human research protection regulatory review and approval mechanism based in a deployed military combatant command. The absence of such a system presented a critical impediment to implementation of the time-honored tradition of a robust combat casualty care research effort. A coalition of concerned military medical personnel from the US Army proposed a novel mechanism to meet Department of Defense (DOD) requirements for the human research protection oversight of studies conducted in the combat theater of operations. In 2005, the Commander of Task Force 44 Medical Command (44th MEDCOM), who was serving as the Multi-National Corps Iraq (MNC-I) Surgeon, was charged with negotiating a DOD Assurance and implementing a new system of research review and protections. He deployed an Army Medical Department Medical Corps officer to assist in this endeavor and operationalize the plan. On March 19, 2005, the Multi-National Corps Iraq Commander signed a historic agreement with the US Army Surgeon General who developed a regulatory support and oversight mechanism to conduct research in theater. This innovative system not only honored the Army's commitment to human research protections, but also provided much needed support in the form of scientific and ethical review and compliance oversight to those deployed medical personnel with the vision to conduct healthcare studies in the combat environment. On July 20, 2005, the first DOD Assurance of Compliance for the Protection of Human Research Subjects was approved for MNC-I. This assurance allows the conduct of human subjects research in full compliance with all Federal, DOD, and Army regulatory requirements. This article describes that unique process.