August 7, 2008 – The U. S. Department of Veterans Affairs’ top health official will hold off on deciding whether to halt human research at the Central Arkansas Veterans Healthcare System until the institution corrects problems identified in a federal report released Wednesday.
In the report, the Veterans Affairs Office of Inspector General found numerous recordingkeeping and procedural errors in the system’s research program, including lack of consent forms for some subjects participating in research, failure to get patient permission for HIV tests and poor record keeping.
The report also criticized researchers for not reporting the deaths of 105 patients who were part of medical experiments, but it clarified that none of the deaths are believed to be related to the research.
It faulted the Central Arkan- sas Veterans Healthcare System and the University of Arkansas for Medical Sciences, which housed the institutional review board responsible for overseeing the system’s research.
While the problems at the central Arkansas system are serious, they are not isolated, said Dana Moore, deputy assistant inspector general for healthcare inspections with Veterans Affairs.
“We do see the oversight of research as a problem that’s not just at Little Rock but a bigger problem across the system,”Moore said.
Over the past 12 months, the inspector general’s office has released five reports detailing problems with research oversight at institutions around the country, including Birmingham, Ala.; Albuquerque, N. M.; and Phoenix. Rep. John Boozman, R-Ark., said his concern is with the “with the care and safety of the veterans.” “I think there’s real concern that the VA and UAMS acted very sloppily in record keeping. There’s no indication at all that that reflects on the quality of care,” he said. “My understanding is that UAMS and the VA have excellent quality of care, but in regard to their research it appears that they did not do a very good job at all.”
‘SERIOUS ISSUES’ In a July 11 response to the report about the Central Arkansas Veterans Healthcare System, Veterans Affairs Undersecretary for Health Brig. Gen. Michael J. Kussman said “serious issues”highlighted in the report require his “continuous attention and oversight.”
The Veterans Health Administration’s Office of Research Oversight has done six on-site reviews of the central Arkansas system since the investigation began in August 2007.
Kussman, also a medical doctor, has asked the oversight office to continue monitoring the central Arkansas health-care system with weekly conference calls, written reports and visits to ensure it continues to take corrective actions.
“Upon complete implementation, I will make a final decision on continuing human research at this facility,”Kussman said in his response.
The Central Arkansas Veterans Healthcare System had 208 research projects involving human subjects as of March 18, according to the report.
A spokesman for the system declined comment Wednesday.
“The final draft of the report was just issued today, and we’d like to take some time to digest it, make sure we know everything that’s in it,”Laurie Driver said.
In a statement Tuesday, the health-care system said it is implementing an “aggressive action plan”to address problems cited in the report. The system established its own institutional review board in August 2007 to oversee research and has increased oversight, required training for scientists and suspended “questionable studies,”according to the news release.
The system has until Dec. 31 to fully implement its action plan, after which Kussman will review matters, according to the inspector general’s office.
“The new managers there have taken steps to address [the concerns ], but their corrective actions are not yet fully implemented, and we remain concerned about the status of human subject protections at the facility,”said Moore, the VA deputy assistant inspector general. In a statement late Wednesday, Kussman’s office said he has “total confidence that the current leadership is conducting robust oversight for the safety of participants and the integrity of research.”In a statement Wednesday, U. S. Rep. Vic Snyder, D-Ark., said the report is “painful to read”for those who value medical research and know the “outstanding quality of medical researchers at both the Little Rock VA and UAMS.” “The Little Rock VA and the Department of Veterans Affairs now must aggressively prove to all of us by the on-going remedial actions underway that human subjects volunteering for medical research can be confident that they will be treated in compliance with the most rigorous standards,” Snyder said. “I am confident they will succeed.”
THREE VISITS For the investigation, the inspector general’s office visited the Little Rock facility three times since August 2007, interviewed dozens of research personnel and reviewed 13 research projects and thousands of documents, according to the report.
Investigators also interviewed officials with the Food and Drug Administration, the VA Office of Research Oversight and the VA Office of Research and Development.
In additional to citing problems at Central Arkansas Veterans Healthcare System, the report faulted the institutional review board at UAMS for failing to “suspend or terminate the researchers or research projects involved”when it found problems, including one case that was audited six times.
“For this reason, we found that the IRB failed to identify and address serious and continuing noncompliance,”the report said.
UAMS Chancellor I. Dodd Wilson said protection of patients participating in medical research is a top priority at the institution. The institutional review board, made up of volunteers from UAMS and the community, makes decisions on a case-by-case basis after careful discussion, Wilson said.
“In several instances they were probably too slow, and they need to improve that,”he said.
The report cited other problems. In a study concerning a new coronary-bypass surgery technique, for example, the report found investigators failed to notify participants of bleeding risks after a patient in the study was evacuated by air ambulance because of a hemorrhage the day after follow-up angiogram surgery.
Investigators also criticized the attending physician’s absence when the surgery was done by another doctor.
The report also cited studies in which researchers tested participants for HIV without their consent and failed to get witness signatures for a study of dementia patients.
Investigations into research practices at the Central Arkansas Veterans Healthcare System started after the institutional review board’s hot line got a call reporting “shredding and destruction of consent forms”in a study involving 750 breast cancer patients.
Wilson said the call came after the study was closed. The researcher – with approval from the institutional review board’s chairman – removed identifying numbers and contact information of women participating in the study as a means of protecting their identity.
The UAMS board reviewed the case and found no wrongdoing, but the U. S. Food and Drug Administration opened its own investigation and took possession of all research files from the study in October 2006.
In the report, Office of Inspector General officials said they “find it disturbing”that UAMS contends that identifying information was removed from forms for all 750 patients in the case the day before an audit.
But Wilson said the audit was unannounced and the patients could still be identified by signatures at the bottom of consent forms.
“Somehow that’s gone from a hot-line allegation to a federal investigation,”Wilson said.
Wilson said UAMS is continually improving its institutional review board, reviewing research protocol and taking new steps to ensure compliance with federal regulations.
The university is hiring a fourth auditor to review ongoing research projects and a person to educate researchers about regulatory requirements.
“We’re a good institution, we’re an ethical institution, and we’re not happy about this [report ],”Wilson said.
The inspector general’s report is available online at www. va. gov / oig /.