The Washington Times reports something that sounds like a bombshell in the local medical community:
An investigation of research conducted at an Arkansas veterans hospital has uncovered rampant violations in its human experiments program, including missing consent forms, secret HIV testing and failure to report more than 100 deaths of subjects participating in studies.
The Office of the Inspector General of the Department of Veterans Affairs (VA) on Tuesday will release its findings in a report on human subject protection violations at the Central Arkansas Veterans Healthcare System in Little Rock. The studies involved thousands of veterans who had volunteered for behavioral and drug experiments.
The investigation, which began last August, reviewed more than a half-dozen human experiments – including studies of colon, breast and prostate cancer – that had been conducted since 2006.
It found that entire consent forms were missing, signatures were missing from consent forms, HIV testing was conducted without documented consent, and research officials failed to obtain witness signatures in a study involving patients with dementia.
Additionally, the investigation found that researchers had failed to report “serious adverse events” during the experiments, including the deaths of 105 veterans. The researchers were required to report such events, regardless of whether they were accidental or linked to the experiments, to the Internal Review Board.
The board, which conducted oversight of the experiments, had been implemented and operated by the University of Arkansas for Medical Sciences but was transferred to the VA after the investigation began. The VA created a review board and halted all new experiments involving human subjects.
UPDATE: I’ve talked with Dr. I. Dodd Wilson, chancellor at UAMS. He defended the hospital work and said the newspaper report has erred in some places and taken some incidents out of context. None of the investigations involved medical treatment or experimental drug protocol and those investigations most at issue for procedural shortcomings were of a particularly limited nature, he said. More on the jump.