By Brendan Parent, Mary Homan, Olivia Kates, Wadih Arap, Brian Childs, and Kathy Kinlaw.
Our bodies can have value after our death. Organs can be donated to save multiple lives through transplantation. Preserved cadavers or body parts may contribute to medical education to prepare future physicians to practice medicine on the living. Dead bodies can also be kept connected to machines – heart beating, lungs breathing, but all brain functions irreversibly ceased – to test new kinds of medical treatments and techniques, again with the intent to benefit the living.
Recently, mainstream news introduced the world to this type of research, reporting on genetically edited pig kidneys that were surgically attached to recently deceased humans. Amazingly, one case produced urine and responded well to anti-rejection medications for 61 days. This kind of experiment can help to span the wide gap between pre-clinical research in nonhuman animals and trying novel techniques in living humans. Animals are sometimes poor models for how interventions will work in humans. So being able to test a new drug, product, or practice on a dead body, without putting living people or animals at risk, can be both more effective and less harmful. But who should give permission for using a dead body like this? Should researchers obtain consent directly from the patient prior to participation in this research after death? What rights does the family have when their deceased loved one is utilized in this way? How should we talk about or treat these bodies, when they look like sleeping patients and their hearts are beating? Can the deceased be harmed?
There have been a few studies involving what we call “research involving the recently deceased” in the past several decades. Now, many institutions are preparing to launch new studies involving the recently deceased. Thanks to ethics guidance in the early 2000s, oversight committees have been established to consider the unique ethics questions that arise from this kind of work. But there has been no comparative analysis of how these oversight committees function, including who serves on them and what they investigate in the approval process. We do not know what protocols research teams are using to approach family members to ask for informed consent and provide support, and to treat the deceased with adequate respect. We have little empirical information about the perceptions and experiences of family members who have agreed to research on their deceased loved ones, or of clinical staff who maintain the deceased during research, or of the general public whose donated bodies could one day be used in this research.
Consider the following hypothetical: A sister agrees to allow researchers to test a technique for delivering an experimental gene therapy using the body of her recently deceased brother, while the body remains in a hospital bed and connected to a ventilator. She knows her brother would have wanted to contribute to important scientific research, but he also wanted an open casket funeral wearing his best suit. When the research team says this should not be a problem, she authorizes the study, which is expected to last three weeks. She makes arrangements for her brother’s funeral to take place at the end of the study. At first she gets daily reports from the research coordinator that “the patient” is doing great. But after seven days, she gets a late-night call from the research coordinator who says, “something did not go as planned,” and the study has to be terminated early. Her brother’s body has been disfigured by an unexpected side effect, and before researchers can return his body for a funeral they need to run tests to see if there is any risk of viruses spreading from the body. Now, his sister has to wait to find out whether his body can be delivered for a funeral service at all or must be cremated; if a funeral is possible, she has to find out if the previously planned services can be rescheduled; and she may be unable to honor her brothers’ wish for an open casket viewing, in light of the changes to his body.
What could have been done differently? In the consent process? In initial communications? In delivering the news of unexpected events? What should be done to support the sister now? And how might such an experience affect her views – and the public’s view – of medical research, and of medicine? How should this research protocol change going forward?
Research involving the recently deceased has the potential to facilitate safer and swifter advancements in transplantation, medical education, gene therapy, pharmacogenomics, and several other fields to improve human health. This model’s success on any significant scale depends on public trust, and this trust requires respect and proactive partnership. Several empirical bioethics investigations need to be performed about research involving the recently deceased in close collaboration with donor family members, clinical staff, organ procurement organizations, and the general public to better prepare for the potential widespread adoption of this study model, and the unexpected events that will come with it.
Paper title: Research involving the recently deceased: ethics questions that must be answered
Authors: Brendan Parent,1* Olivia Kates,2 Wadih Arap,3 Arthur Caplan,1 Brian Childs,4 Neal W. Dickert,5,7 Mary Homan,6 Kathy Kinlaw,7 Ayannah Lang,8 Stephen Latham,9 Macey Levan,1 Robert D. Truog,10,11 Adam Webb,5 Paul Root Wolpe,7 Rebecca Pentz8,5
Affiliations:
1 NYU Grossman School of Medicine
2 Johns Hopkins Medicine
3 Rutgers New Jersey Medical School
4 Mercer University School of Medicine
5 Emory University School of Medicine
6 CommonSpirit Health
7 Emory University
8 Winship Cancer Institute
9 Yale University
10 Harvard Medical School
11 Boston Children’s Hospital
Competing interests:
WA is a founder, equity stockholder, and scientific advisor of PhageNova Bio and of MBrace therapeutics. PhageNova Bio and MBrace Therapeutics partially support his academic laboratory through Sponsored Research Agreements. WA has previously out-licensed intellectual property related to findings potentially discovered and/or validated through translational research involving recently deceased human subjects or terminal-wean patients at the end of life. These relationships are currently managed according to established institutional conflict of interest policies of Rutgers, The State University of New Jersey. BP directs transplant ethics and policy research which is in part supported by a gift from United Therapeutics.
Social media accounts of post authors:
Formerly known as Twitter:
@katesolivia
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@Brendan Parent
@Mary Homan