VA cites problems with research across the country
Posted on Saturday, August 9, 2008
URL: http://www.nwanews.com/adg/News/233707/
The Central Arkansas Veterans Healthcare System isn’t the only medical center recently cited by the U. S. Department of Veterans Affairs Office of Inspector General for violating federal rules on research with human subjects.
Over the past 12 months, the office has issued six reports about problems at research programs around the country, including in New Mexico, where researchers failed to get permission to collect blood samples in Mexico. Alabama researchers were criticized for not password-protecting a hard drive that had personal information for more than 530, 000 veterans that was later stolen.
In Arizona and Texas, researchers were cited for poor record-keeping and allowing unlicensed personnel to examine and perform minor surgery on patients.
Veterans Affairs is working to correct problems with research oversight in Little Rock and other facilities around the country, said Dana Moore, the department’s deputy assistant inspector general for healthcare inspections.
“We believe that this is not an isolated case of problems,” she said.
Federal research violations have been widespread enough that the inspector general’s office last year compared compliance at Veterans Affairs medical centers that use university boards to oversee research with those that have their own oversight boards.
The report, issued last September, found more problems at facilities with universitybased boards.
Responding to the report, Undersecretary for Health Brig. Gen. Michael J. Kussman said he asked the agency’s Office of Research Oversight to “fully explore” the “effectiveness of university [institutional review boards ] for VA research programs.”
The Arkansas report, released Wednesday, cites various violations at Central Arkansas Veterans Healthcare System, including missing or incorrectly signed records, failure to get research participants ’ permission to test their blood samples for HIV and a lack of witness signatures for a study of dementia patients.
The report also criticized Arkansas researchers for not reporting the deaths of 105 veterans who were part of longterm cancer studies but clarified the deaths aren’t believed to be related to the research.
In addition to Central Arkansas Veterans Healthcare System, the report faults the Uni- versity of Arkansas for Medical Sciences’ institutional review board for failing to “identify and address serious and continuing noncompliance.”
The board oversaw research at the Little Rock VA for more than 10 years until August 2007, when Veterans Affairs officials decided to form their own institutional review board.
Dr. Margie Scott, chief of staff at Central Arkansas Veterans Healthcare System, said VA facilities around the country have broken away from university-based review boards over the past decade because of many of the same problems experienced in Little Rock. Veterans Affairs’ rules differ from other institutions on things such as how quickly review boards are expected to take action when errors are found. It’s not uncommon for the VA to require disciplinary action within 24 hours, and the UAMS board simply couldn’t respond quickly enough, Scott said. “It’s simply a necessity to have the level of oversight that we think is necessary.”
‘ADVERSE EVENTS’ Pulaski County Coroner Garland L. Camper said he plans to investigate the 105 unreported deaths.
In a letter Thursday, he requested the VA send him the patients’ names, birth and death dates, Social Security numbers, copies of death certificates and contact information for family members. Camper said he plans to compare the information with records in his office.
“I think it’s best that we examine what’s actually happened in the deaths of those individuals,” Camper said Friday.
Scott, at Central Arkansas Veterans Healthcare System, said the 105 deaths were unreported in four studies involving breast, prostate and colon cancer patients. Many patients participating in the studies were spread around the state, and therefore likely died outside Pulaski County.
The lead researcher for the studies was Dr. Nicholas Lang, a surgical oncologist and former chief of staff at Central Arkansas Veterans Healthcare System. Lang retired from the VA in May 2007 to take the position of chief medical officer at UAMS in June 2007.
Scott said none of the four studies involved experimental drugs or treatments. Lang was simply studying patients to learn about the progression of their diseases.
“He was not in charge of the patients’ care, he was following them over time,” she said Thursday.
Because of the nature of the studies, Lang said he didn’t believe he was required to report the deaths.
Scott said federal rules require Veterans Affairs researchers to report “serious adverse events” such as hospitalization or death of research participants so that those overseeing the research can make sure there was no connection to the study.
“You never know if something that you think might not be related could be related,” Scott said. Failure to report adverse events was a common problem cited in the September report by the inspector general’s office. The report found that 43 percent of chairmen of VAbased institutional review boards said their facilities commonly reported adverse events to the Veterans Affairs Office of Research Oversight. Only 13 percent of chairmen of university-based institutional review boards said their facilities reported adverse events. Kussman said there is “considerable confusion” about rules on adverse event reporting and that the VA is working to address the issue with clarified rules, oversight and training.
PROBLEMS ELSEWHERE In June 2007, the Veterans Affairs Office of Inspector General issued a report criticizing researchers at the Birmingham VA Medical Center in Birmingham, Ala., for failing to protect information on a backup hard drive used for research with encryption or passwords.
The issue came to light after the hard drive was stolen in January 2007. It contained personal health information for more than 530, 000 veterans and information about more than 1. 3 million doctors, hospitals and other health-care providers that researchers got from the Centers for Medicaid and Medicare Services.
The Federal Bureau of Investigation in Birmingham is still advertising on its Web site a $ 25, 000 reward for return of the hard drive or information about those responsible for its disappearnce.
Researchers with the New Mexico Veterans Affairs Health Care System were criticized in a November 2007 inspector general’s report for collecting blood samples from people in Mexico without permission from their institutional review board.
The researchers also were cited for transporting the blood across the U. S. border without appropriate U. S. Customs documentation.
Other problems with the New Mexico research program included that researchers failed to remove information identifying patients from consent forms; that medical records were missing; and that a tissue bank that wasn’t approved by the VA was used.
In Arkansas, Scott said the VA plans to complete an “action plan” to address problems with oversight of its research program before the end of the year. After that, the undersecretary of health said he will re-examine the situation and determine if research with human subjects should be allowed to continue at the Little Rock facility.
Three doctors have lost research privileges at the facility, and 200 research projects have been closed either because research was complete or over protocol concerns.
The board plans to fully review each of the ongoing 143 research projects over the next three months, reviewing every document, form and file, Scott said.
“It’s a very complete process,” Scott said. “We still think the findings are significant and it’s very important that we address them appropriately because the bottom line is patient safety absolutely comes first.”