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The Erosion of Informed Consent in Medical Research

Hand holding bag containing human organ for transplantOver the past several years, I’ve written in this blog about several incidents involving informed consent (Informed Consent for Babies: When Experts Disagree; Informed Consent in Infant Research: Ethical Problems Remain; and Informed Consent in Comparative Effectiveness Research).

The issue is back, this time with a twist. In the latest episode, a study involving kidney transplantation from deceased donors took place at several hospitals. Researchers wanted to see whether cooling kidneys before a transplant would result in fewer post-transplant complications than the usual practice of keeping the kidneys at normal body temperature.

The lead institution’s Institutional Review Board (IRB) determined that the study was not “human-subject research” because the kidney donors were deceased and the researchers did not need to obtain informed consent from the transplant recipients.

How Can Transplant Recipients Not Be Considered Human Subjects?
In order to try to understand how researchers might be permitted to conduct research without obtaining informed consent from study participants, it’s important to look at the justifications offered for forgoing the usual procedures. Of all the recent cases involving informed consent, the justification for this one is the most bizarre and the hardest to comprehend.

While it is true that U.S. federal regulations define research as an activity conducted on “living human beings,” the deceased kidney donors were certainly not the research subjects. The definition in the regulations says “Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains: (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.”

The recipients of the kidneys were living human beings, and the purpose of the study was to see whether the group that received the cooled kidneys would fare better than recipients in the other group. How could the IRB at the lead institution, the University of California, San Francisco, have overlooked this obvious fact and determined that the dead donors were the subjects? How could the researchers who designed the study and specified its purpose ignore that the living recipients of cooled or not-cooled kidneys were the actual subjects?

The kidney transplantation study was sponsored by the Department of Health and Human Services and was partly conducted by the U.S. Department of Veterans Affairs (VA). Michael Carome, the director of the consumer-rights advocacy group Public Citizen, wrote to both the VA and the Office of Human Research Protections (OHRP), calling for an investigation of the study on the grounds that it violated federal regulations. The VA’s Office of Research Oversight (ORO) conducted an investigation, and in a letter from the ORO to Public Citizen dated October 26, 2016, and signed by the ORO executive director, it agreed with Public Citizen’s assessment that the study violated federal rules for research involving human subjects.

At the time of this posting, OHRP has not responded.  The agency is located within the US Department of Health and Human Services and its website describes its role as providing “leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research….”  OHRP did a good job in finding deficiencies in the informed consent documents in the SUPPORT study (Informed Consent in Infant Research: Ethical Problems Remain).  A full investigation takes time and human resources, and the agency may well be understaffed. We await OHRP’s response to this latest episode in the hope that the official agency that oversees government-sponsored research will continue to do its job in protecting the rights and welfare of human subjects of research in the United States.

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