A consumer group named Public Citizen filed ethics complaints against Portland VA for unethical kidney transplant trails at the facility that lacked consent.
The trial paperwork indicated the kidney transplant trial subjects were deemed “nonhuman” despite kidneys being transplanted into live humans. The study failed to seek informed consent through normal channels because of the “nonhuman” classification.
The Portland VA Medical Center and University of California, San Francisco (UCSF) were involved in the study. Drs. Daren Malinoski and Claus Niemann led the study. Dr. Malinoski works at Portland VA. The Institutional Review Board (IRB) was conducted by UCSF.
The complaint from Public Citizen said participants in the study were not informed of the nature of the transplanted kidneys. Those kidneys came from brain dead donor bodies where the body was cooled prior to removal of the kidney as part of a study. The kidney gathered at experimental temperatures was then placed into a live human for research.
The purpose of the study was to gauge whether colder kidneys would result in quicker acceptance of the organ. The meta-goal of the study was to find cheaper ways to transplant kidneys.
PORTLAND VA / UCSF STUDY ERRORS
The recipients were apparently not informed. According to the Public Citizen complaint, the organizations failed to reach a few obvious and common sense related conclusions prior to the study being conducted:
- Failure to recognize trial as involving human subjects research
- Failure to satisfy IRB review and approval requirements
Not surprisingly, these two researchers and the IRB panel failed to recognize the subjects of the study were human. While the donors were brain dead, the recipients of the kidneys subject to the cooling experiment were most certainly human.
Should we be surprised that Ivory Tower type researchers would erroneously conclude recipients of experimentally harvested kidneys are not human? Do you ever wonder if VA at large considers us humans with rights, at all?
The complaint indicates that the error of judgment about the humanness of the study resulted in the participant doctors failing to seek informed consent from the 572 recipients.
This news made me wonder an obvious question:
How many more similarly mistaken IRB reviews have concluded veterans are not humans where informed consent is required?
In the name of conducting human experiments to save money, researchers apparently concluded humans were not humans. How many of these “nonhumans” were veterans?