Investigation finds problems in Central Ark. veterans' health care
The Department of Veterans Affairs' Office of Inspector General looked into allegations of human subjects protection violations at the Central Arkansas Veterans Healthcare System and found violations in the areas of informed consent and adverse event reporting.
According to the OIG's report, researchers obtained HIV tests on subjects without their consent; could not provide informed consent documents for all subjects enrolled in the protocols; did not appropriately obtain witness signatures for demented patients enrolled in research protocols; and that researchers did not report deaths occurring during the course of the protocol, although these deaths were most likely not related to the research. Other problems reported include missnig protocols, discrepancies in reports and failure of principal investigators to obtain the requisite skills, training and experience to conduct the research.