The First Human Body Transplant – Ethical and Legal Considerations

By Ana S. Iltis, PhD

brain_glowingprofileTo what lengths should we go to preserve human life? This is a question many are asking after hearing that three men plan to make medical history by conducting the first human head transplant. Or, rather, whole body transplant. Italian neurosurgeon Dr. Sergio Canavero and Chinese surgeon Dr. Xiaoping Ren plan to provide a Russian volunteer, Valery Spiridonov, a new body. During the procedure, Spiridonov’s body and head would be detached and, with the help of a crane, surgeons would move the head and attach it to the donor body.  But is this ethical? What role might law and regulation play in monitoring them or in assessing their conduct after the fact?

Critics call the plan crazy, unethical, and sure to fail. The likelihood of success is very low and the risk of Spiridinov dying is high. Spiridonov says that as soon as animal studies confirm the possibility of survival, the risks will be worth taking. He has Werdnig-Hoffmann Disease, a genetic disorder that destroys muscle and nerve cells. He is confined to a wheelchair and has lived longer than expected. Body transplantation offers him the best chance at a life worth living.

Drs. Canavero and Ren say that their animal research success puts them close to the first human attempt. Looming over this assertion are questions about what the animal studies show and what they mean by ‘success.’ To date, most of their research on rodents, dogs, and primates has not been published in scientific journals, generating skepticism about the validity of their claims. Given this, it is unlikely that the procedure would be approved under typical pathways for overseeing surgical innovation or human research. Research that is subject to regulatory oversight in the United States and many other countries requires approval by an institutional review board (IRB) or its equivalent. Conditions for approval typically include minimizing risks to participants and demonstrating that the risk are reasonable relative to the anticipated benefits. An IRB would want to see convincing animal data and evidence of the ability to fuse human spinal cords before taking Canavero and Ren’s proposal seriously. Although Canavero’s team almost certainly would operate outside the sphere of federal oversight were they to proceed in the US, the fact that their plan would not meet those standards raises ethical concerns.

Innovative surgical interventions often are not subject to research regulations and IRB review but many recognize the importance of independent peer oversight, especially when they pose significant risks. Peer review would consider, among other things, whether the potential benefits justified the risks and whether there was enough evidence to support the innovation. Given what many physicians have said in response to the idea of a body transplant and the minimal amount of quality published scientific evidence, Canavero and Ren’s proposal likely would not fare well in a surgical innovation peer review process either.

If, as many expect, Spiridonov dies as a result of the procedure, what kind of legal action might the team face? The answer depends on where the surgery occurs. They are unlikely to find many peers willing to defend their actions as consistent with the responsible practice of medicine. Thus, in many jurisdictions they might face criminal prosecution or civil liability. Avoiding this has been a priority for Canavero.

The body transplant team may proceed outside any oversight mechanism and avoid criminal and civil liability by choosing their location and funding sources carefully.  They need funders who do not require IRB or peer review. They need a location with few laws and regulations governing medical practice or research, or where they are minimally enforced. Canavero has been studying his options. Recently, he announced plans to proceed in China using a Chinese donor and recipient, instead of Spiridonov. It is not clear what led him to choose China, but there are clues. China has the facilities and trained health care professionals necessary to execute the plan. While China’s research regulations are comparable to those of many Western nations and reflect principles found in international research ethics guidelines, enforcement varies. China also lacks a consistent and robust medical malpractice system.

Canavero has made much of the importance of informed consent in defending his plan. Whether the patient’s consent is valid and whether it would absolve the team of wrongdoing is questionable. Precisely to what a patient will consent is unclear. If it is to undergo a high-risk innovative surgical intervention, the consent might be invalid. No amount of disclosure and voluntariness replaces the obligation to solicit informed consent only for medically appropriate interventions for which the risks are justified. Given the current state of knowledge, that requirement has not been met.

Alternatively, Canavero might obtain consent to kill the patient in a procedure akin to physician assisted death (PAD). This poses a number of problems. Patients may consent to medically appropriate procedures that expose them to a risk of death. But outside of physician-assisted death cases, which must meet strict standards, we do not generally recognize persons as having the authority to consent to being killed. In China and many other places PAD remains illegal, so consent to PAD would not be valid. Even where one may consent to be killed or to receive medical assistance to end one’s life, the comparison of PAD to death in an attempted body transplant fails. The patient’s and physician’s goals are different. In PAD, the patient’s survival would constitute a failure, but here it would be a success. Consent to PAD typically requires confidence in the patient’s desire to die, yet the opposite holds here. Finally, decapitation is not a recognized method for PAD and would fall well outside the standard of care.

While the body recipient’s death raises numerous ethical and legal questions, so would his survival. Canavero routinely has spoken of the person whose head is used as the survivor. As with the ship of Theseus, how many parts may we replace and justifiably think that the person’s original identity survives? Body transplantation forces us to think about what makes us who we are, how the mind and body are related, and whether and how we maintain our personal identity over time. In receiving a new body, Spiridonov’s mind, rather than the body donor’s mind, will be preserved. But the identity of the new body-head combination is more complicated. Transplants require immunosuppression therapy to prevent rejection of foreign tissue. Will Spiridonov’s head’s immune system be suppressed to prevent rejection of the body? Or will the goal be to prevent the body from rejecting the head? If the “new Spiridonov” has children, whose children are they biologically? The sperm the “new Spiridonov” will produce will carry the body donor’s DNA.

Even if the surgery goes as planned and the new head-body combination lives, will the costs be justified? Not only will the surgery be very expensive, but several lives could be saved if the donor’s body were used for routine organ transplants instead. How high-performing would the “new Spiridonov” have to be and how long would he have to live to call it a success and to say it was worth the costs? The answer likely depends on whom you ask.

A version of this post appeared at S&T Policy at BIPP.

The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.

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