Healthcare Inspection Human Subjects Protections Violations at the Central Arkansas Veterans Healthcare System Little Rock, Arkansas

The purpose of the inspection was to determine the validity of allegations regarding human subjects protection violations in research. We substantiated the allegations of documentation irregularities and human subject protection violations and that the affiliate Institutional Review Board (IRB) was aware of the problems and failed to appropriately follow up on the issues. We found missing documentation and failure to report serious adverse events. We also substantiated the allegation that the IRB failed to identify and address serious and/or continuing noncompliance and failed to ensure that investigators had the requisite skills to conduct their research. We identified a number of systemic issues which placed human subjects at risk and substantiated that the facility’s Research and Development (R&D) Committee failed to protect human subjects. While we found that current facility leadership has made significant improvements to the R&D program, the persistence of problems indicates that the R&D program as a whole at this facility may reflect a culture of noncompliance. We recommended that the Under Secretary for Health should determine if it is appropriate to continue human research at the facility, and if the decision is to continue, should provide a plan to ensure that research complies with VHA standards.