Public Citizen Had Called for Investigation Into Blatant Ethics Violations and for Disclosure to Patients Who Were Unwitting Experimental Subjects
WASHINGTON, D.C. – Agreeing with Public Citizen, the U.S. Department of Veterans Affairs’ (VA’s) Office of Research Oversight (ORO) has found that a clinical study involving hundreds of kidney transplant patients violated federal rules for the protection of human research subjects. The findings, outlined in a letter the ORO released late Wednesday, stem from an investigation conducted by ORO in response to Public Citizen’s April 20, 2016, letter calling on the VA’s ORO and the U.S. Office for Human Research Protections (OHRP) to launch an ethics investigation into the study and to disclose the details of the experiment to the hundreds of patients who unwittingly participated.
ORO’s letter confirms Public Citizen’s allegations that the study was incorrectly determined not to involve human subjects research and, as a result, the transplant patients enrolled in the study were not afforded the protections required under federal regulations, including the requirement that the researchers obtain the subjects’ voluntary informed consent prior to their enrollment.
The purpose of the study was to test whether cooling kidneys before a transplant would result in fewer post-transplant complications. 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.
As originally detailed in Public Citizen’s April 20 letter, 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, the IRB failed to adequately review and approve the trial in accordance with federal regulations to protect human subjects, including provisions related to informed consent.
“We applaud ORO for promptly investigating our complaint and for reaching what was the only reasonable conclusion: This study involved human subjects research,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “It is disturbing that the university’s review board concluded that this study involved solely deceased kidney donors and failed to recognize that the living kidney transplant recipients were human subjects. This led to serious violations of the rights of these patients who were the unknowing guinea pigs in this experiment.”
The kidney transplant study was funded by the U.S. Department of Health and Human Services (HHS) 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 had asked the VA’s ORO and the OHRP 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.
Because the VA’s ORO does not have direct oversight authority over the UCSF or the other non-VA hospitals where kidney transplant patients were enrolled in the study, the VA’s ORO is not able to sanction these institutions, nor can VA officials require that investigators inform the subjects of their unwitting enrollment in the experiment. The OHRP has such authority. But to date — in contrast to the VA’s ORO — the OHRP has not yet even opened a formal compliance oversight investigation into this research.
“The failure of the OHRP to promptly initiate a formal compliance oversight investigation of our complaint reflects a troubling pattern of inadequate enforcement of the federal human subjects protection regulations by the HHS office over the past several years,” Carome said. “The OHRP needs to stop turning a blind eye to obvious violations of federal regulations and of research subjects’ rights.”