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Related Experiment Videos

Establishing a human research protection program in a combatant command.

Laura R Brosch1, John B Holcomb, Jennifer C Thompson

  • 1US Army Nurse Corps, Office of Research Protections, United States Army Medical Research and Materiel Command, 504 Scott Street, Fort Detrick, Maryland 21701, USA. laura.brosch@us.army.mil

The Journal of Trauma
|April 11, 2008
PubMed
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Military medical research faced challenges in combat zones due to a lack of oversight. A novel system was developed to ensure human research protections, enabling ethical studies in deployed environments.

Area of Science:

  • Military Medicine
  • Human Research Protection
  • Regulatory Affairs

Background:

  • US combat operations resumed in 2003, revealing a gap in regulatory oversight for human research in deployed military commands.
  • This absence impeded crucial combat casualty care research efforts.
  • Existing systems were insufficient for the unique demands of research in a combat theater.

Purpose of the Study:

  • To establish a human research protection regulatory review and approval mechanism within a deployed military combatant command.
  • To address Department of Defense (DOD) requirements for oversight of studies conducted in combat theaters.
  • To facilitate ethical and compliant healthcare research in operational environments.

Main Methods:

  • A coalition of US Army medical personnel proposed a novel oversight mechanism.

Related Experiment Videos

  • Negotiation of a DOD Assurance and implementation of a new research review system by the Commander of Task Force 44 Medical Command (44th MEDCOM).
  • Operationalization of the plan by an Army Medical Department Medical Corps officer.

    • Main Results:

    • A historic agreement was signed on March 19, 2005, between the Multi-National Corps Iraq (MNC-I) Commander and the US Army Surgeon General.
    • The first DOD Assurance of Compliance for the Protection of Human Research Subjects was approved for MNC-I on July 20, 2005.
    • This established a system for scientific, ethical review, and compliance oversight for deployed healthcare studies.

    Conclusions:

    • The implemented system successfully addressed the need for human research protection in combat theaters.
    • This innovative approach enabled compliant healthcare research, supporting deployed medical personnel.
    • The process established a precedent for conducting human subjects research in compliance with all regulatory requirements.