April 20, 2016
Researchers Failed to Obtain Informed Consent From Patients Involved in Kidney Transplant Experiment
Public Citizen Calls for Investigation Into Blatant Ethics Violation and for Disclosure to Patients Who Were Tested
WASHINGTON, D.C. – A clinical study involving kidney transplants violated rules for the protection of human subjects, Public Citizen said in a letter today. The letter calls on the U.S. Office for Human Research Protections (OHRP) and the U.S. Department of Veterans Affairs’ (VA’s) Office of Research Oversight (ORO) to launch an ethics investigation into the study and to disclose the details of the experiment to the hundreds of patients who unwittingly participated.
The purpose of the study was to test whether cooling kidneys before a transplant would result in fewer post-transplant complications, such as delayed graft function. In the study, 572 patients received kidneys from deceased donors whose bodies either were kept near normal body temperature or were slightly cooled following declaration of brain death. Prior to the study, the researchers acknowledged that both the benefits and, importantly, the risks of such cooling for transplant recipients were unknown.
The major problem is that the institutional review board (IRB) at the University of California, San Francisco (UCSF) – the lead institution for the study – incorrectly determined that this research constituted “nonhuman subjects research under U.S. federal law, since the patients were deceased.” As a result of this clear error, UCSF’s 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 participating patients, Public Citizen contends.
“UCSF’s IRB disturbingly concluded that this study solely involved deceased kidney donors, failing to recognize that the living kidney recipients were human subjects. This led to serious violations of the rights of these patients who were the unknowing guinea pigs in this experiment,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group and an author of the letter. “What were they thinking? How could the IRB – and the researchers – have come to such an obviously wrongheaded conclusion? These patients deserve the truth about their involvement in the experiment as well as a clear explanation of how and why the authorities responsible for protecting them got it so wrong.”
The study was funded by the U.S. Department of Health and Human Services through a grant from the U.S. Health Resources and Services Administration and was conducted, in part, by the VA. Thus, both the OHRP and the VA’s ORO have jurisdiction over this research. Public Citizen is asking the OHRP and the VA’s ORO to launch a joint compliance oversight investigation and to appropriately sanction all institutions engaged in the study for failing to protect the human subjects who were enrolled in the research.