mTBI Research Trial Comes Under Fire from DoD IG

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WASHINGTON—A military research clinical trial evaluating the use of antioxidants to reduce sequela of mTBI in 80 troops after blast injury has come under fire by DoD’s Inspector General (IG).

After receiving allegations of problems with the trial, the IG’s office investigated and found that the “management and conduct of the trial were inconsistent with military standards for human subject medical research.” In addition, it found there was “possible substandard patient care,” and that there are “weaknesses in the process used to review and approve medical research in Iraq.”

The trial took place at Camp Al Taqaddum, Iraq, between December 2008 and March 2009. Led by a Navy physician, the study sought to examine the use of an anti-oxidant, N acetylcysteine (NAC) in individuals who suffer blast injury and demonstrate early sequela of mTBI, according to the trial description on ClinicalTrials.gov website. The study hypothesized that giving NAC for seven days would result in improved hearing and balance function in individuals who demonstrate these disorders after blast exposure when compared to a placebo medicine at the seven-day time point.

“Evidence exists in laboratory work and in human studies that anti-oxidant medicine can reduce/eliminate the sequela of mTBI if administered within 8-24 hours of injury,” the trial description stated.

The IG investigation sought to determine whether DoD guidance regarding research on human subjects was violated, and whether research misconduct occurred in the trial. According to the “results in brief” released, the IG recommended that the DoD undersecretary of defense for acquisition, technology and logistics update medical research policies ensuring that rights of deployed personnel are protected from “coercion and undue influence to participate in research studies.”

In response, military leaders have updated draft DoD Instruction 3216.02, “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research” according to the brief.

The IG advised coordination with the military services to “ensure DoD and Service level medical research policies are pertinent to research conducted in a joint-service environment.” In addition, the review also recommended that the assistant secretary of defense for health affairs conduct health assessments to determine if there were any adverse effects on the 80 troops who participated in the trial.

Gary M. Comerford, a spokesperson for DoD’s IG, said that further details of the allegations and the investigation would be released in a redacted report.

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