Learn more about our policy experts.

Media Contacts

Angela Bradbery, Director of Communications
w. (202) 588-7741
c. (202) 503-6768
abradbery@citizen.org, Twitter

Don Owens, Deputy Director of Communications
w. (202) 588-7767

Karilyn Gower, Press Officer
w. (202) 588-7779

David Rosen, Press Officer, Regulatory Affairs
w. (202) 588-7742

Other Important Links

Press Release Database
Citizen Vox blog
Texas Vox blog
Consumer Law and Policy blog
Energy Vox blog
Eyes on Trade blog

Follow us on Twitter


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.


Copyright © 2017 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.

Public Citizen, Inc. and Public Citizen Foundation


You can support the fight for greater government and corporate accountability through a donation to either Public Citizen, Inc., or Public Citizen Foundation, Inc.

Public Citizen lobbies Congress and federal agencies to advance Public Citizen’s mission of advancing government and corporate accountability. When you make a contribution to Public Citizen, you become a member of Public Citizen, showing your support and entitling you to benefits such as Public Citizen News. Contributions to Public Citizen are not tax-deductible.

Public Citizen Foundation focuses on research, public education, and litigation in support of our mission. By law, the Foundation can engage in only very limited lobbying. Contributions to Public Citizen Foundation are tax-deductible.