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Bioethics Forum Essay

When Are Organ Recipients Human Research Subjects?

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.

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  1. It seems logical and necessary that receiving an organ that was part of a research study prior to transplantation would naturally extend participation in the study to the patient who received the organ. What seems less clear to me is why we are conducting research on organs that are viable for human transplantation when there is such a deficit of donor organs? I understand the need to see how organs react to various stimuli, but why if they could save a life? I think the question of whether or not “human research subject” status extends to transplant recipients should be secondary to questions of whether or not the organ is viable for transplantation. If so, don’t start the research on it in the first place.

    But if it is already done, then transplant recipients should have full knowledge of any research conducted on the organ they are to receive and be allowed to make an informed decision on whether or not to move forward with the transplant. Patients in need of organ transplants are often desperate, yes, but they are also often very ill and may not want to attempt a transplant with an organ that has been tampered with.

  2. While many patients with rare or untreatable cancers can seek the latest studied treatment plan and look to enter various research studies, this is not the case for many. There are several patients who would prefer to not be the subject of research. However, as soon as these patients walk into a hospital, they carry the potential to be involved in a research experiment. A large group of patients in which further research is needed are transplant patients. As Macklin and Shepherd discussed, organ recipients should not only have a right to know and that they are considered research subjects. This is a stance I agree with. Personally, I believe that if one is receiving anything that is a component of a research study, they should be considered a research subject for the most expansive information regarding the medical treatment to be garnered, but also for the patient to receive all the possible resources for aid that comes with a research study. But, the consent to being part of a research study is a more tricky conversation.
    As with many aspects of medical care, consent is a huge component of any treatment. Bodily autonomy plays a huge part in this, and patients deserve the right to know about each aspect of their care and play a factor in this decision-making process. Therefore, patients should have the right to know whether they are receiving an organ transplant that is part of a research study. They should receive education regarding the risks and benefits of participating in a research study, and the fact that an organ coming from a research study is something they can choose or not choose to consent to. While it is unfortunate that some may opt out of studies given this, it is important for patients to always have medical control over their bodies; to be sick, live a health life, or die in the means which they receive the most dignity and respect that can be given to them. This ultimately can be achieved by full transparency and autonomy.
    But there is a lack of education when it comes to medical science research. Leaving this decision to patients is a right, but it is also one that can be difficult and dangerous. As research is always needed in medicine, particularly organ transplantation, the world has experienced many issues with implementing such research. There was a lot of fall out regarding vaccines for COVID-19 and many people who preferred not to get vaccinated due to lack of research about the vaccines already. There is a potential for a similar situation like this as many patients may prefer to not be a part of a research study and might reject participating in such a study. It is important for medical researchers to discuss this with patients, but also for education regarding research to be more widespread throughout the world. If more patients understood that research is truly a basic tenet of modern medicine, and it is required for any advancements to be made, then there might be more people that are willing to participate in such studies. Furthermore, research is conducted in the medical world on a daily and minute by minute basis. It is not always an IRB approved study, it could be a unit testing out the newest and greatest device to measure cardiac output, or nurses evaluating the best system for medication education. In whole, research is integral to medicine and more education for the public could be conducted regarding this topic.
    However, this can be a difficult decision in terms of a pediatric patient or a patient who is very medically fragile (whether intubated and sedation, encephalopathy due to hepatitis, etc.) prior to organ transplantation. These patients deserve the same education regarding risks and benefits of participating in such a research exploration. But conversations regarding end-of-life care are often not brought up until it is too late, and family members and or the proxy may not know what their family members would prefer to have done; much less whether they would like to be considered a part of research. This again leaves the medical team and patient in a very tricky situation. It is the right of the patient to have this opportunity as it is a basic consent (as Macklin and Shepard discussed regarding research consent). It is difficult to truly know the patient’s decision in this period.
    In conclusion, due to a lot of nuances in the medical system, it is difficult to reach a conclusion regarding consent with an organ transplant that might be involved in a research study. However, due to the principle of autonomy, it is imperative that patients are informed about the procedure they are agreeing to and the potential to be part of a research study. These patients have the right to decline any medical treatment they would prefer, whether the treatment is a vaccine or an organ that is part of a medical research study. Furthermore, if these patients consent to the research, they are then considered a research subject in order to receive the full medical support of the study.

  3. To address the original question, organ recipients should be considered research subjects, if the transplanted organ is a part of a research study. As mentioned in essay, researchers are investigating how the transplanted organ affects the patient’s prognosis, quality of life, etc. The recipient is an integral part of the study because the most in-depth research cannot be conducted, on the effects of an organ, outside of the human body. Prospective studies are conducted in the medical field for all types of procedures/devices; the people receiving these interventions are considered research subjects. Just because the intervention is an organ, does not make the recipient any less of a research participant. Given this, it is important to give patients the necessary information, as it pertains to their care. If patients are being made aware that the transplanted organ is being used for research, it should be confirmed and understood by the patient that they are research subjects. That is true, informed consent, in this scenario.

    There was a comment that some patients may refuse an organ, for fear or discomfort of being research subjects. This is not an appropriate reason not to disclose all the information to the patient. There are three ways I can respond to this type of thinking. Firstly, people have a right to refuse any treatment; to not fully inform patients, to circumvent this right, is unethical. Second, we know that there are more patients in need of transplants, than organs available. It is a sad truth, but the reality is, if one patient refuses treatment, there are likely other eligible research participants. Finally, we can use the research study as a basis to (ethically) encourage treatment. Research studies sometimes offer incentives for participation. If having a large enough pool of participants is truly an issue, why not use incentives, such as coverage for medications needed during the recovery phase. (Obviously, this facet is a bit more complex; it would need to be carefully considered, to stray away from the coercion line. It is just a vague example.)

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