VA Investigation Uncovers Human Subject Protection Violations In Medical Research

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Just months after a less than positive veteran suicide report and a lawsuit filed against the VA for its slow processing of PTSD disability claims, the Department of Veterans Affairs has a new battle to fight.

According to an article on veteransforcommonsense.org, a recent investigation at an Arkansas medical facility uncovered some pretty poor record keeping practices associated with human subject protection violations in association to research studies that were being conducted on veterans. Although thousands of veterans had allegedly volunteered for drug and behavior research at the facility, the investigation found that many consent forms were missing or improperly signed.

As laid out in the summary section of the IG Report:

We found that researchers obtained Human Immunodeficiency Virus tests on subjects without their consent; could not provide informed consent documents for all subjects enrolled in the protocols; and did not appropriately obtain witness signatures for demented patients enrolled in research protocols. We further found that researchers did not report deaths occurring during the course of the protocol, although these deaths were most likely not related to the research.

In addition to missing informed consents, four protocols were missing other key information and data related to the subjects recruited in the study. There were discrepancies in the number of subjects reported as being recruited to the Institutional Review Board (IRB) and to ORD. Other issues identified included the failure of principal investigators to obtain the requisite skills, training and experience to conduct the research.

We further found that the IRB was aware of many of these deficiencies well before our review, and had failed to suspend or terminate the researchers or research projects involved. In one instance, a single protocol had been audited at least six times, with the results communicated to the IRB on each occasion. For this reason, we found that the IRB failed to identify and address serious and continuing noncompliance

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The report goes into greater detail, describing the numbers of human subjects whose participation in the medical research might have been taken advantage of. Although no deaths were believed to be caused by the experiments, the report did criticize the medical facility for not reporting over 100 deaths that occurred during the testing.

One case had been audited six times and was allowed to continue. Another case involved the destruction of certain documents one day prior to an audit.

In a Northwest Arkansas news report, it was reported that the VA top health official Brig. Gen. Michael J. Kussman would put off making any decision on pulling human research at the facility. Despite the magnitude of the problems of improper record keeping, the issues are on a much greater level, as VA deputy assistant inspector general Dana Moore said "We do see the oversight of research as a problem that's not just at Little Rock but a bigger problem across the system."

There have been similar reports from five different locations across the country over the past 12 months, dredging up major concerns over the actual care of veterans being seen at these facilities.

The facility plans on dealing with the problems head on by implementing an "aggressive action plan." Kussman will give them until December 31, 2008 to fully execute its plan prior to taking any action.

The University of Arkansas for Medical Sciences Cancellor I. Dodd Wilson defended the centers practices, citing patient protection as priority. He did say that certain practices were slow and required some improvement.

Whether an institutional issue or a problem that has simply gotten out of hand at medical facilities across the country, human subject protection violations are serious. Informed consent for human studies should be treated like the crown jewels. Veterans are humans, not guinea pigs and are certainly not subjects in an experimental lab where rules do not apply.

Lets hope this facility gets their aggressive plan in action for reasons other than saving their own facility funds.