Anasthasia Shilov

The story of life does not end with death, but in some cases, death is where the law ends, according to a new article published in the Journal of Medical Ethics.

First published online on Sept. 28, the article examines the ethics of testing manufactured organs on brain-dead individuals. The authors, hailing from Yale and New York University, provided guidance on conducting this kind of research to United Therapeutics Corporation and concluded that practices should be drawn from existing research areas’ systems.

“There are laws about donating your body to a medical school, for example, for anatomy class, and there are laws about donating organs, but there is not much law about how to get families’ consent for the use of a body in a research project,” said co-author Stephen Latham, who is also the director of the Yale Interdisciplinary Center for Bioethics. This creates what he called a “borderland” between organ procurement for transplant and research on human subjects that the authors filled in with their article, entitled “The ethics of testing and research of manufactured organs on brain-dead/recently deceased subjects.”

United Therapeutics, which sponsored the work, studies tissue engineering for lungs, according to Latham. The company needed guidance from bioethicists because the U.S. government has yet to develop a policy on using dead people for artificial organ research. Current laws define human subjects as being alive, so using recently dead bodies poses a “pretty substantial legal gap,” Latham said.

“You wouldn’t want to test a lung for transplant in someone who really needed a transplant,” Latham said. “Testing it in recently deceased people, brain-dead people whose hearts were still beating, would be about as good a model as you could get before you started working in subjects.”

After making recommendations for United Therapeutics, the group generalized their findings in an article published in the Journal of Medical Ethics for other researchers, according to Tamar Schiff, a research scholar in Transplant Ethics and Policy Research at NYU Langone Health. The guidelines include how researchers should select deceased candidates and communicate with family members to maximize transparency and sensitivity.

Latham said that the “best candidates” for research using tissue-engineered organs are people who had volunteered to be organ donors but who were not eligible for donation because of the condition of their organs at death. In that case, “the research team could approach the family” and explain to them “another way in which you and your loved one could help with the organ donation issue,” he said.

Additionally, Latham said researchers have to discuss burial, removal from the hospital and physical appearance after an experiment with families when asking for donation of a body.

The report also recommends the creation of a board to review research proposals that involve the recently deceased, similar to institutional review boards already established for protecting living human research subjects.

“The importance of gathering these different ‘stakeholders’ is to ensure that the perspectives of all people who would be affected by this kind of research are represented in decisions about oversight,” said Brendan Parent, the report’s author and director of Transplant Ethics and Policy Research at NYU Langone Health.

Still, not all bioengineering research currently requires use of the recently deceased, according to John Geibel, a Yale School of Medicine professor of surgery and of cellular and molecular physiology, who has worked on 3D bioprinting of organs for over four years.

Geibel said bioprinting still has many years to go before it can directly test organs in the recently deceased due to the complexity of human organs. He also noted that cost is a major barrier. For example, Geibel said that replacing a rat’s aorta requires roughly between 200 and 250 million cells, which would incur significant costs for materials such as reagents and plasticware in which to grow the cells. Even then, he said the recipient’s immune system could reject the new organ.

Moreover, Geibel cited his experience with families he encountered during his intestinal research as a possible factor to slow the use of the recently deceased in research. Family members, he said, are often reluctant to give consent to use organs for research if they will not be used for transplant.

Researchers would also have to explain to families that biotechnology companies may turn a profit from the organ research, according to Latham. However, he noted that “most of what we wrote in this paper would be applicable to a non-profit company or a for-profit company.”

Megan Wu ’23, who signed up to be an organ donor when she got her driver’s license, said she “would be okay with” using her body for bioengineering research purposes, saying it “could actually be very helpful for someone.” However, she said that when you “consider money,” more ethical implications arise.

Even with potential barriers, such as cost and family reluctance to donate, Latham said he “think[s] that this kind of research will become more common as we get better at tissue engineering, and also it might become more common for implantable medical devices of various kinds.”

In that respect, Latham said he was “hoping our paper will help people set [research] up more easily.”

Over 113,000 people are on the national transplant waiting list as of July 2019, according to the U.S. Health Resources and Services Administration.

Giovanna Truong | giovanna.truong@yale.edu