Human subjects violations cited in report on AR facility
Investigators: IRB failed to follow-up problems
A Veterans Health Administration hospital in Arkansas is currently being monitored by the VA after an investigation found human subjects protection violations on a number of protocols.
A report from the VA's Office of Inspector General (OIG) was released in August alleging problems with research protections at the Central Arkansas Veterans Healthcare System (CAVHCS) in Little Rock. Violations identified included lack of documentation, informed consent issues and inadequate IRB follow-up when problems were identified.
As a result of the investigation, the undersecretary for health at the VA, Michael Kussman, ordered continued monitoring by the Veterans Health Administration until remedial actions have been taken at the facility. "Upon complete implementation (of the remedial actions), I will make a final decision on continuing human research at this facility," Kussman said in a statement.
At the University of Arkansas for Medical Sciences in Little Rock, whose IRB was until recently the affiliate IRB for CAVHCS, university officials say they're working to improve auditing, training and communication, programs that were under way even before the investigation. But they dispute many findings in the report, calling them sensationalized and misleading.
"It's very frustrating to try and deal with a report like that when they're not giving the whole story and you spend a lot of time trying to clarify things," says Bob Bishop, UAMS vice chancellor for institutional compliance. "We're not saying that everything was perfect, but recognizing that there are going to be errors and you're trying to identify them accurately."
Addressing allegations
They note that much of the detail in the report came from the UAMS IRB's own audits, and that their attempts to delve further and make changes were halted when federal officials ordered studies to be closed.
Among the specific violations cited in the OIG report:
Documents, including informed consent and subject eligibility documents, appeared to be missing from study files in a number of studies. Jennifer Sharp, a UAMS research compliance officer, says the documents in question originally were in the study files. She believes they probably were misfiled as files were moved from agency to agency during the investigation.
"We know that all the consent forms were present at least at one point in time when we looked at one of the studies," Sharp says. "The investigators' files were first looked at by the FDA, then the VA OIG took those records and so the PI has never been given an opportunity to assist in reorganizing these documents and locating some of these things."
The report states that deaths of 105 veterans involved in four studies were not reported to the IRB in continuing review forms. Although the OIG report states that it is unlikely any of the deaths were related to the patients' participation in studies, VHA policy still requires that they be reported.
"Even though you may think a death had nothing to do with a research study, all deaths are supposed to be reported," says Dana Moore, PhD, the OIG's deputy assistant inspector general for healthcare inspection. "Maybe people involved in a study started having car accidents at some alarming rate. Maybe there is something going on."
Bishop and Sharp, however, say that in all but one of the studies, the investigator's involvement with the patient was brief, in some cases lasting only a day. Since there was no long-term follow-up in the protocol, there was no opportunity for the investigator even to know that the patient had died.
The OIG report stated that during a study of coronary artery bypass surgery, a subject receiving a required follow-up angiogram in 2006 had complications requiring air evacuation to an outside hospital. The IRB approved an addition to the informed consent explaining this risk. Subsequent audits showed that not all patients involved in the study had been given the new consent document. The OIG report charged that the IRB failed to identify and report continuing non-compliance in that case.
Bishop says subsequent audits showed that patients were only given the new consent form when they came in for their one-year follow-up angiogram.
"The reality was that almost everyone who was supposed to get a follow-up angiogram was accounted for," he says. "Either they left the study, they had the procedure or they had a different procedure or didn't come back for some reason."
Not an isolated issue
Since the investigation started, the CAVHCS has created its own IRB, with seven members of the previous UAMS IRB moving to it. There have been leadership changes at the CAVHSC as well and the OIG reports that the new leadership has made significant changes in response to concerns raised in the report.
The VHA itself issued a directive in March detailing a facility's obligation to conduct protocol audits.
At UAMS, Bishop says the university is revamping its compliance system, enabling it to better audit the IRB's operations. The university also is seeking an additional auditor and Sharp says they're looking at the education program to see where there might be improvements.
Moore says the VA's OIG has investigated alleged human subjects protection violations at a number of veteran's hospitals over the past few years, with some investigations involving IRB problems.
"We don't think Little Rock was an isolated issue," she says.
Bishop says many VA facilities are moving toward establishing their own IRBs. For those university affiliates who remain, he advises prompt attention to the results of audits.
"I think based on our experience, probably the IRB needs to be a little more active," he says. "In some actions that normally they might want to look at a little longer, I think they need to look at acting more quickly."
A Veterans Health Administration hospital in Arkansas is currently being monitored by the VA after an investigation found human subjects protection violations on a number of protocols.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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