When Are Organ Recipients Human Research Subjects? [Or donors?]

[Clark]

http://www.thehastingscenter.org/organ-recipients-human-research-subjects/

When Are Organ Recipients Human Research Subjects?

By Ruth Macklin and Lois Shepherd

Do the recipients of organ transplants have a right to know if the organs they are about to receive were part of a research study? If so, are the recipients themselves research subjects? A recent article in the Hastings Center Report maintains that the recipients do have a right to know, but that they are not research subjects. We agree with the former judgment, but not the latter. Ethical treatment of recipients of this type of organ research requires them to be treated as research subjects, provided the usual manner of informed consent to receive the manipulated organs, and to be under the research protection of an institutional review board.
The article discusses a controversial hypothermia study in which more than 500 patients received kidneys from donors who, upon declaration of brain death, had been randomly assigned to an experiment to see whether cooling kidneys before a transplant would result in fewer post-transplant complications than the usual-care alternative of keeping the kidneys at normal body temperature.
The authors argue that the transplant recipients in research like the hypothermia study are recipients of clinical care; they can refuse an offered research organ just as they can refuse any organ.  But the entire point of the research is to determine the effect of the intervention on the recipient. It is not to determine the effect of the research maneuver on the deceased donor. Nor is it to determine the effect of the research on the organ if the organ is never transplanted into a living recipient.
Let us suppose that all potential recipients were asked whether they would accept an organ transformed in some way by research and—for whatever reason—all declined. Could the research carried out on the organ be of any value whatsoever? All the relevant data derives from the effect of the altered organ on the recipients.
The argument advanced by the authors relies heavily on the somewhat inartful language of the Common Rule, which defines a human subject as “a living individual about whom an investigator . . . conducting research obtains 1) Data through intervention or interaction with the individual, or 2) Identifiable private information.”  The intervention, they argue, is a clinical one rather than a research one. The data are not obtained through the intervention (like venipuncture) but rather by accessing information from databases of transplant outcomes (i.e., not associated with personal identifiers). But clever as this argument is, it ignores the essential fact that the treatment received by the recipient has been altered for research purposes.
Consider this analogy. Imagine that scientists have perfected an artificially manufactured organ. It would be considered a device (like the artificial heart) and subject to Food and Drug Administration regulations, so it would fall under federal regulations for research. The artificial organ is studied and eventually approved by the FDA. Now imagine that scientists introduce a small change to the artificial organ and seek to compare the altered device with the FDA-approved version. When FDA-approved devices are altered and studied, they fall under FDA regulations for research with human beings. Shouldn’t recipients of altered human organs be similarly protected? If not, why not?
We appreciate that the transplant environment adds challenges to conducting donor intervention research. But the fact that this kind of research puts vulnerable patients in a take-it-or-leave-it position would seem to call for more, not less, research protection oversight. The ethical question is: Do recipients have a right to know that the organ they are about to receive was manipulated as part of a research maneuver, to refuse to have the manipulated organ transplanted, and to be assured that the study was reviewed by an appropriate IRB? If the answer is yes, then in any ordinary understanding of “research subject,” that’s what they are.
Ruth Macklin, PhD, is professor emerita of Albert Einstein College of Medicine, a Hastings Center Fellow, and the recipient of The Hastings Center’s Henry Knowles Beecher Award. Lois Shepherd, JD, is the Peter A. Wallenborn, Jr. and Dolly F. Wallenborn Professor of Biomedical Ethics and a professor of public health sciences and of law at the University of Virginia.

Published on: November 10, 2017
Published in: Clinical Trials and Human Subjects Research, Hastings Bioethics Forum, Health and Health Care, Organ Transplantation