Ethical issues in conduct of research in combat and disaster operations.

BACKGROUND: The conduct of research in the combat and disaster environments shares many of the same fundamental principles and regulations that govern civilian biomedical research. However, Department of Defense research protocols stipulate additional requirements designed to preserve servicemembers' informed consent rights, uphold ethical standards, and protect sensitive or classified information. The authors reviewed studies that have been approved for the conduct of research in current combat operations and also discuss their applicability in disaster settings. METHODS: This is a descriptive, retrospective study of protocols that have currently been approved for conduct of research in Operation Iraqi Freedom and Operation Enduring Freedom. RESULTS: During the period of July 2005 through October 2007, 38 retrospective chart review protocols, seven prospective studies requiring consent or an alteration of the consent document and 12 prospective observational studies were submitted through the Deployed Research Committee in Iraq for review and approval at the Brooke Army Medical Center Institutional Review Board (IRB). A total of 55 protocols were approved by the IRB for implementation in the Iraq combat theater. Most of these protocols involved trauma care treatment. One prospective study investigating the effects of blast-concussive injuries on US Soldiers in Iraq requiring informed consent was reviewed and approved. CONCLUSIONS: The conduct of military medical research has, and will make, significant and lasting contributions to the practice of both civilian and military medicine. Although policies and regulations to conduct research and release-associated findings often seem cumbersome and stringent, these added hurdles serve not only to ensure protection of the rights of human subjects during a time of potentially increased vulnerability, but also to protect the security interests of US troops. Many of these principles and practices are directly applicable in disaster research environments.