Interventional research to preserve the viability of donor organs means the transplant recipient is a research subject entitled to give informed consent — period, says bioethicist Ruth Macklin, PhD, professor emerita at Albert Einstein College of Medicine.

Macklin refutes the contention by scholars that a concept of a blanket, “clinical consent” to receive a research organ would streamline the process. Proponents of this approach say it would remove barriers, emphasizing that “interventional research on deceased organ donors and donor organs prior to transplant holds the promise of reducing the number of patients who die waiting for an organ.”1 (For more information, see the story in the December 2017 issue of IRB Advisor.)

Macklin recently co-authored an essay2 arguing that if the organ is manipulated in some way to prolong viability for transplant, or presumably any other reason, the recipient must give informed consent.

“Clinical consent presumes that the people who are the recipients of these organs are not research subjects,” Macklin tells IRB Advisor. “We argue that the people who receive an organ that has been manipulated through a research protocol are research subjects. It is clear what the motivation is — as soon as you have to ask people for consent to research, there will inevitably be some people who will refuse. They may refuse irrationally, they may refuse knowingly, or refuse for no reason, but that is the right of research subjects and patients.”

A high-profile case in 2015 and 2016 brought the issue into the public eye and the ethical arena. The watchdog group Public Citizen argued that kidney recipients from a hypothermia study were, in fact, research subjects and should have been asked to grant informed consent.3,4 The Office of Research Oversight at the Department of Veterans Affairs essentially agreed with them, though the IRB in the case had ruled the study posed minimal risks to the organ recipients and that informed consent was not needed. Advocates of this type of research argue that they are trying to improve transplantation, remove barriers, and extend the viability of organs post-transplant.

“My argument is basically if the organ is manipulated, informed consent is required from the recipient because the recipient is a research subject. It is no different from any other kind of research,” Macklin says. “Of course, they don’t want barriers, but these are the rules. This has been a standard for many, many years in treating human subjects. These investigators are trying to turn the clock back several decades and say, ‘We don’t really need consent for this kind of thing. Let’s just call it treatment.’ Well, it’s not just treatment.”

However well-intentioned organ investigators and their advocates are, critics like Macklin see this approach to research as a threat to a cardinal ethical principle.

“Once they start doing something to the organ, you have an organ that has been manipulated for research purposes,” she says. “If this were something under the scrutiny of the FDA — if it were an artificial or mechanical kidney — of course the recipient would be a research subject. The question is, if a genuine human organ has been manipulated, why isn’t that subject to the same kind of research considerations?”

Proponents of using research organs without informed consent underscore that the risk-benefit ratio clearly favors the recipient on a list awaiting a transplant. Again, Macklin begs to differ.

“The risks are whatever the standard risks to a transplant patient would be, plus the added risk of the research,” she says. “When you are doing research, you don’t know what all the risks are — that’s why it’s research. There may be great benefit to others in the future if you have these manipulated organs that turn out to be better than non-manipulated organs, but you don’t know that in advance.”

REFERENCES

1. Heffernan, KG and Glazier, AK (2017), Are Transplant Recipients Human Subjects When Research Is Conducted on Organ Donors? Hastings Center Report 2017:47:10–14.

2. Macklin R, Shepherd L. When Are Organ Recipients Human Research Subjects? Hasting Center Bioethics Essay, Nov. 10, 2017. Available at: http://bit.ly/2B2sbsL. Accessed Dec. 8, 2017.

3. Carome MA and Wolfe SM. Letter to J. Menikoff and K. Borror, Office for Human Research Protections, and J.T. Puglisi, Office of Research Oversight, U.S. Department of Health and Human Services. Public Citizen, April 20, 2016. Available at: http://bit.ly/2zn2iT2. Accessed Dec. 8, 2017.

4. Niemann CU, Feiner J, Swain S, et al. Therapeutic Hypothermia in Deceased Organ Donors and Kidney-Graft Function. N Engl J Med 2015; 373:405-414.