Violations rife in hospital's studies on veterans

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By Audrey Hudson

The University of Arkansas for Medical Sciences did not respond to calls for comment.

The VA employs strict guidelines for consent forms and witness signatures for experiments involving veterans to ensure that volunteers are fully informed of all risks and possible side effects associated with the experiments.

When a veteran signs a consent form, the principal research investigator is supposed to sign the form as well. However, the inspector general (IG) found that in one test the researcher did not sign nearly 200 forms until two months later. In four studies reviewed by the IG, times, dates and witness signatures differed on 103 consent forms.

In a review of several cancer studies involving 1,400 veterans, investigators randomly sampled the files of 105 patients and could locate only 20 consent forms.

The findings are being released on the heels of July 9 IG report prompted by a Washington Times/ABC News joint investigation that the VA failed to pass on new drug warnings and risks in a timely manner to more than 200 participants in a smoking-cessation study who were also taking the drug Chantix. The eventual warnings of hallucinations and possible suicidal behavior were issued too late for James Elliott, who was subdued by police with a stun gun during a psychotic breakdown.

The IG said researchers in the smoking study "did not ensure that patients involved in the smoking cessation study were notified of the risk of suicidal thoughts or behavior in a timely manner."

The IG also said it could not confirm whether warning letters reached the intended study participants, and more than half have not signed and returned amended consent forms advising that the drug may cause hallucinations or psychotic or suicidal behavior.

In Arkansas, the IG report found fault with the IRB operated by the University of Arkansas for Medical Sciences, saying it "failed to identify and address severe and continuing noncompliance."

"Every protocol [study] discussed in this report was audited and deficiencies were identified and communicated to the IRB," the IG said. "The IRB did not suspend or terminate any of them prior to outside inspections."

In addition, the IG said there was a failure to ensure researchers had required skills and training to conduct the clinical trials, and that unlicensed research personnel performed some medical procedures it described as "minimally invasive."

One study to determine the success rate of heart surgeries required a cardiac catheterization one year later to see how open the arteries remained, but the procedure was performed on only one out of 70 patients.

In another study reviewed by the IG, the principal researcher told the IRB that no subjects were enrolled in the experiment, but told the Office of Research and Development that 47 veterans had been recruited for the study. The IG found that $138,000 had been spent on study-related expenses.

All research by one physician was suspended after it was discovered he was reviewing the medical records of 678 veterans for a study that never received approval.

As of March 18, the hospital was conducting nearly 300 active research projects, 200 of which used human participants and 55 that were evaluating investigational drugs. The IG recommended that the VA determine whether human subject research should continue at the hospital and to take appropriate administrative action.

In addition to creating the internal review board, the VA has since hired new officials to take over as chief of staff, assistant chief of staff for research and development and a new medical center director.