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Working with Human Tissues for Translational Cancer Research

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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

Summary

This summary is machine-generated.

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.

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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.
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.