VA releases report critical of Arkansas hospitals

VA releases report critical of Arkansas hospitals

A federal report has found researchers working at the Central Arkansas Veterans Healthcare System failed to follow rules governing human experimentation, including not telling those in a surgery trial about another participant’s medical emergency following the procedure.

A report by the inspector general’s office of the Veterans Affairs Administration found researchers also conducted several HIV tests without patients’ permission, filmed dementia patients without consent and destroyed records just before a federal audit. The report says the University of Arkansas for Medical Sciences’ internal review board, which oversaw the researchers, also failed to follow up to make sure researchers corrected the problems in several cases.

Though both UAMS and the veterans hospitals have made changes in the time since, investigators said further review is necessary.

In a statement yesterday, the hospital system said it was undergoing changes after the report. System spokeswoman Laurie Driver said today that officials needed more "time to digest" the report and declined to comment further. UAMS officials have scheduled a news conference this afternoon to discuss the report.

Arkansas is home to about 262,000 veterans and the VA operates three major medical centers in the state.

VAOIG Executive Summary is posted below:

Human Subjects Protections Violations at the Central Arkansas Veterans Healthcare System

Executive Summary
 

The VA Office of Inspector General received allegations related to research integrity and human subjects protection violations in research projects conducted at the Central Arkansas Veterans Healthcare System. To evaluate these allegations, we made three site visits, catalogued thousands of pages of source documents, interviewed dozens of individuals with relevant information, and met with officials from the Food and Drug Administration, the Office of Research Oversight, and the Office of Research and Development (ORD). We reviewed 13 research projects and described the facility’s research program in detail.

We substantiated the allegations of human subjects protection violations in the areas of informed consent and adverse event reporting. 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.

We note the facility has made several attempts to address these problems. The Medical Center Director, Associate Chief of Staff for Research and Development, and Chief of Staff are all relatively new to the facility. The facility formed its own IRB, and embarked on an educational program for its researchers regarding human subject protections. Despite these efforts, we remain concerned about the status of human subject protections at the facility. We therefore recommended that the Under Secretary for Health determine whether research involving human subjects should continue at the facility; and if it should continue, develop a comprehensive plan for addressing the problems identified in this report. We further recommended that appropriate administrative action be taken based upon the findings contained within this report.