Are Organ Transplant Recipients in a Trial Protocol Considered Research Subjects?
A complex issue that is key to greater organ availability
Given the high demand for organ donation, there arises a critical point when the donor is dead but the organs are still viable for transplant. Research protocols to extend this viability period are of great interest, but does that mean organ recipients must give informed consent as research subjects? Here we enter an ethical impasse, that if adequately resolved could increase the supply of organs for transplant.
Some argue that a concept of “clinical consent” would be appropriate given the pressures and difficulties already attendant in an organ recipient. The idea is that a population at considerable risk from a variety of conditions that go with needing an organ donation could give clinical consent to receive an organ from someone in a research protocol if it became available.
“Recipients have to process all of these things, but in our view, prior research on an organ can easily fit within that existing framework [of risk],” says Kate Gallin Heffernan, JD, a partner in the Verrill Dana law firm in New York City. “In bolstering that as a piece of the clinical conversation, you are not just leaving people with no information. You are actually finding a better way to give the information that is pertinent to their decision. In some ways, this could reduce the ethical conundrum because you are not asking them about research participation in the moment when they are deciding, ‘Do I take an organ which may or may not be my last chance to get one?’”
Heffernan co-authored a paper on the subject, noting 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
However, currently “the perception that the existing regulatory barriers are insurmountable has all but shut down clinical research that is necessary to expand the pool of available organs,” she concluded in the paper.
“This is primarily a logistics and timing issue,” Heffernan tells IRB Advisor. “Given the way our organ allocation system works, you don’t know until the offer is made and accepted where an organ will go. Until the allocation occurs, you don’t know who your research subject is — if you are going to assume that the [organ recipient] is a research subject. So, in terms of being able to get IRB approval ahead of time for every single transplant at any number of centers it may go to is almost logistically impossible.”
Though the issue was already subject to some difficulties, a high-profile complaint that likely created a chilling effect was filed by the public watchdog group Public Citizen.
The group argued that kidney recipients from a hypothermia study were, in fact, research subjects and should have been asked to grant informed consent.2,3 The Office of Research Oversight at Veterans Affairs essentially agreed with Public Citizen, though Heffernan argues in her paper that they erred in doing so. The IRB, in fact, deemed that the study posed minimal risks to the organ recipients and that informed consent was not needed, she notes.
“The whole purpose of the work that is being done by transplant researchers in this area is with the hope of finding ways to better improve transplantation and the viability of organs post-transplant,” she says.
Heffernan says the situation warrants creation of a national centralized review board that could provide critical oversight of interventional organ donor research. Centralized review would allow for the creation of reliance arrangements between medical centers that could facilitate IRB review and address any ethical issues before the critical moment when the organ becomes available for transplant.
“This would be a way to sort of front-load some of the evaluation of the research ethically so that you aren’t faced with the real-time moment where it can’t go forward because you can can’t get the [local] IRB to review it in a timely manner,” she says. “Some studies will require an IRB-level oversight for the recipients. Others may not. They would just need to have the ethics review that we all agree should be in place.”
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. Carome MA and Wolfe SM. Public Citizen. 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, April 20, 2016. Available at: http://bit.ly/2zn2iT2. Accessed Nov. 6, 2017.
3. 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.
Research protocols to extend the viability period of transplant organs are of great interest, but does that mean organ recipients must give informed consent as research subjects? Here we enter an ethical impasse, that if adequately resolved could increase the supply of organs for transplant.
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