Complaint Letter to the Office for Human Research Protections and the Department of Veterans Affairs Regarding an Unethical Kidney Transplant Experiment
April 20, 2016
Public Citizen called on the Office for Human Research Protections and the U.S. Department of Veterans Affairs’ (VA’s) Office of Research Oversight to investigate a clinical trial involving kidney transplant patients that was unethical and violated rules for the protection of human subjects. The major problem is that the institutional review board (IRB) at the lead institution for the study incorrectly determined that this research constituted “nonhuman subjects research under U.S. federal law.” As a result of this clear error, the IRB failed to adequately review and approve the trial in accordance with regulations to protect human subjects and failed to ensure that the researchers obtained the voluntary informed consent from the subjects.
October 26, 2016, Final response letter from the VA Office of Research Oversight.