Special Plans and Operations: Assessment of Allegations Concerning Traumatic Brain Injury Research Integrity in Iraq
Abstract
This assessment was initiated in response to allegations brought to the attention of the Department of Defense, Office of Inspector General, concerning the integrity of a traumatic brain injury research project in Iraq. The overall objective of the assessment was to review these allegations and determine whether: DoD guidance regarding the performance of research on human subjects (in this case deployed, injured U.S. Military personnel in Iraq) was violated in a DOD-approved clinical research trial evaluating a treatment for mild traumatic brain injury. Research misconduct occurred during this specific DoD-approved clinical research trial. We visited organizations, conducted interviews, and reviewed records and standards pertinent to the conduct and oversight of the research protocol, "The Use of Anti-Oxidants to Reduce Sequela of Mild Traumatic Brain Injury (MTBI) After Blast Exposure," conducted at Camp Al Taqaddum, Iraq, between December 2008 and March 2009. We considered both U.S. Navy and U.S. Army regulations, because the Principal Investigator for this research was a U.S. Navy physician, and since the U.S. Army Surgeon General approved the DoD Assurance of Compliance for the Multi-National Corps Iraq, setting standards for the conduct of human-subject medical research in Iraq.
Document Details
- Document Type
- Technical Report
- Publication Date
- Mar 31, 2011
- Accession Number
- ADA545918
Entities
Organizations
- Office of the Inspector General, U.S. Department of Defense