Report Expected To Cite Violations At Veterans Affairs Hospital
Last updated Tuesday, August 5, 2008 9:15 PM CDT in News
By John Lyon
The Morning News
LITTLE ROCK - A report scheduled for release today is expected to cite violations of protocol in a human experiments program conducted at the Central Arkansas Veterans Healthcare System and overseen by the University of Arkansas for Medical Sciences.
The Washington Times reported Tuesday the report would cite rampant violations, including missing consent forms and unreported patient deaths.
The Office of the Inspector General of the Department of Veterans Affairs planned to release a report on an investigation into the VA hospital's human experiments, an official with the inspector general's office said Tuesday. The official said she had no information about the content of the report.
University Chancellor I. Dodd Wilson said the newspaper's report sensationalized the investigators' findings and was "full of errors."
Starting last August, investigators with the inspector general's office reviewed several studies involving veterans who had volunteered for experiments, the Times reported. In a random sampling of the files of 105 patients involved in cancer studies, 20 consent forms could be found, the newspaper said.
It reported researchers failed to report the deaths of 105 veterans to the university's internal review board, which was responsible for overseeing the studies, even though they were required to report the deaths of experimental subjects even if the deaths were not related to the experiments.
HIV testing was conducted without documented consent and researchers failed to obtain witness signatures in a study involving patients with dementia, according to the newspaper report.
"Research documentation and procedural issues were detected at the medical center in Little Rock by VA employees, and an aggressive action plan has been developed and is being implemented addressing each of the findings in this OIG report," the hospital's director, Michael Winn, said Tuesday in e-mail.
Winn said during the past year the hospital established a VA internal review board to oversee experiments, established training and auditing requirements, increased the auditing and oversight staff, suspended questionable studies and temporarily halted any new human experiments. The restriction on new experiments was lifted in December 2007.
Winn said there is no evidence any patients were harmed because of procedural errors in experiments at the hospital, but the hospital has established a hot line to address veterans' concerns about their participation in research experiments.
Wilson said Tuesday that in previous internal audits and audits by the Food and Drug Administration, consent forms generally have been found for experiments in the program. During the audits the consent forms were often "split up," however, possibly explaining why the inspector general's office could not find many of them, he said.
The statement in the Times that researchers failed to report "serious adverse events" during experiments, including the deaths of 105 veterans, is not correct, Wilson said. No patients died during or as a result of experiments, he said.
The 105 veterans referred to were cancer patients who took part in a half-day study in which they were given caffeine pills then had their urine tested to study how the pills were metabolized, Wilson said. The veterans died later from causes unrelated to the low-risk experiment, and researchers were not required to report the deaths, he said.
Wilson said a team of researchers did test two patients' blood for HIV without getting documented consent, but the university's internal review board quickly discovered the problem and told the researchers to stop doing the tests.
The internal review board also discovered that in one experiment patients with dementia were videotaped walking even though informed consent was not obtained, Wilson said.
"The IRB shut that study down, but it didn't hurt anybody," he said.
Wilson said he would wait until the inspector general's report is released to release the university's official response to the findings.
CONTACT INFORMATION
Veterans Hot Line
University of Arkansas for Medical Sciences
(866) 722-4838
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recross1 wrote on Aug 7, 2008 11:08 AM: