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Veterans Affairs releases report critical of researchers

LITTLE ROCK—Researchers working at the Central Arkansas Veterans Healthcare System failed to follow rules governing human experimentation, including not telling those in a surgery trial about another participant’s medical emergency following the procedure, a report by federal inspectors found.

A report by the inspector general’s office of the Veterans Affairs Administration found researchers also conducted several HIV tests without patients’ permission, filmed dementia patients without consent and destroyed records just before a federal audit. The University of Arkansas for Medical Sciences’ internal review board, which oversaw the researchers, also failed to follow up to make sure researchers corrected the problems in several cases, the report found.

Though both UAMS and the veterans hospitals have made changes in the time since, investigators said further review is necessary.

“Despite these efforts, we remain concerned about the status of human-subject protections at the facility,” investigators wrote.

UAMS Chancellor I. Dodd Wilson said Tuesday that the studies were “low risk,” despite one incident involving a patient in a program where surgeons used a different technique during a coronary artery bypass graft. The inspector’s report said one patient in the program suffered a hemorrhage and needed to be airlifted to a hospital the day after the 2006 surgery.

Minutes from a later review board meeting showed that the attending physician for the surgery “was present during the procedure, but he was in the next room.” Another doctor not in the study performed the procedure.

The review board ordered all patients be informed of the risk, but the report found that researchers failed to reach some. Researchers said they couldn’t find some patients or those found refused follow-up care.

In another 2006 incident, researchers destroyed consent forms from patients involved in a study after getting approval from the internal review board. The destruction came a day before a federal audit, the report said.

Wilson said Tuesday the tests involved giving people with breast cancer a strong caffeine pill to find out how they metabolized the stimulant.

“The investigator was worried (that), if the names ever got out, it would be a shame for the participating people,” Wilson said.

Wilson said the HIV testing only affected two participants in a study involving exercise and amino acids. Wilson said those conducting the survey didn’t realize they couldn’t do the test and were told to no longer do them.

The dementia study, involving videotaping those with the ailment as they walked around, failed to get signatures from 22 of the 26 involved, Wilson said. He said the study was immediately stopped and those involved “have lost their ability to do research.”

The inspector general’s report asks the VA’s undersecretary for health to determine if human research should continue at the facility. The report also questions why two unidentified high-ranking officials at the hospitals remain in their positions, when they “had every reason to know and understand the requirements of human-subjection protection.”

In a statement Tuesday, the hospital system said it was undergoing changes after the report. System spokeswoman Laurie Driver said Wednesday that officials needed more “time to digest” the report and declined to comment further. UAMS officials had scheduled a news conference for Wednesday afternoon to discuss the report.

Arkansas is home to about 262,000 veterans and the VA operates three major medical centers in the state.



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