Veterans Health Care Oregon

An ethics complaint has been filed against the VA Portland Health Care System over a kidney transplant trial.

(The Associated Press)

A consumer advocacy group has filed an ethics complaint against the VA Portland Health Care System over a clinical trial involving kidney transplants.

Public Citizen accused the Portland medical center and the University of California, San Francisco of violating the rights of kidney recipients by enrolling them in the study without their consent. The study was led by Dr. Darren Malinoski of the Portland VA and the university's Dr. Claus Niemann.

"A review of the New England Journal of Medicine article presenting the trial's results reveals that the trial, as conducted, was unethical and failed to materially comply with key requirements of (Department of Health and Services) and VA regulations for the protection of human subjects," the Public Citizen letter said.

The group has demanded that Veterans Affairs and the U.S. Department of Health and Human Services investigate and sanction the institutions.

A spokesman for Veterans Affairs in Portland declined to comment. He referred questions to Veterans Affairs in Washington, D.C., which did not immediately comment.

The study involved the transplantation of kidneys from 370 brain-dead donors to about 570 recipients between March 2012 and October 2013. About half of the donor bodies were cooled slightly to 93 to 95 degrees while the others were kept at 98 to 100 degrees, which is the standard renal transplant protocol.

The study aimed to test whether kidneys from cooler bodies helped the transplants take more quickly. Transplanted kidneys don't work immediately in about 50 percent of the cases, requiring the recipients to undergo dialysis the first week. That increases health care costs and curtails the longevity of the donor kidney.

The trial was evaluated by the institutional review board at the University of California, San Francisco before it was conducted, according to standard protocol.

The review noted that the donors were at least 18 years old when they died and had signed an authorization allowing their bodies to be used for research. It said donor consent wasn't needed because the trial involved dead people. Recipients weren't informed that they were enrolled in the trial, however. The report in the New England Journal of Medicine said their consent wasn't needed because the study posed minimal risks to the recipients.

But Public Citizen disagreed. It said "the human subjects enrolled in the trial were not afforded the important protections that they deserved."

The trial was ended sooner than expected because the results showed that transplantation from cooler bodies was more successful. Seventy-nine recipients of kidneys from the cooler group had to go through dialysis in the first week compared with 112 in the other group.

-- Lynne Terry