Impassable scientific, ethical and legal barriers to body-to-head transplantation.

This article consists of four parts. In the first part it briefly describes the history of body-to-head transplantation (BHT) and the surgical plan proposed by Drs. Sergio Canavero and Ren Xiaoping on a human subject. In the second part it argues that the BHT procedure that they propose is scientifically invalid and technically infeasible so therefore would end in failure. In the third part it argues that the present conceivable procedure of BHT cannot be ethically justified because it would bring great harm to the human subject, it is uncertain who would be the possible beneficiary, and valid informed consent cannot be obtained. In the fourth part it argues that the action of performing the procedure of BHT might violate China's current criminal and civil laws. The conclusion that follows from the arguments above is that BHT should be prohibited now and also in the near future. However, this conclusion does not preclude scientists, neurosurgeons and bioethicists doing research into scientific, technical, surgical and ethical issues raised by BHT.

Uterine Transplantation: Surgical Innovation in the Treatment of Uterine Factor Infertility.

Uterine factor infertility (UFI) is a condition that affects thousands of women and is estimated to have a prevalence as high as one in five hundred reproductive-aged women. A wide range of circumstances can lead to UFI and include women with congenital absence of a uterus (Mayer Rokitansky Kuster Hauser or MRKH syndrome), women who have undergone iatrogenic removal of the uterus, or women who have uteri that are in situ but have been damaged by infection or surgical instrumentation. There have been 17 published reports of human uterine transplantation in the world. This article will summarize the history of human uterine transplantation and discuss our current understanding of the medical, surgical, and ethical considerations surrounding this innovative procedure.

The ethics of extracorporeal membrane oxygenation in brain-dead potential organ donors.

Organ-preserving extracorporeal membrane oxygenation (OP-ECMO) is defined as the use of extracorporeal support for the primary purpose of preserving organs for transplantation, rather than to save the patient's life. This paper discusses the ethics of using OP-ECMO in donation after brain determination of death (DBDD) to avoid the loss of organs for transplantation. We review case reports in the literature and analyze the ethical issues raised. We conclude that there is little additional ethical concern in continuing OP-ECMO in patients already on ECMO if they become brain dead. The implementation of OP-ECMO in hemodynamically unstable brain-dead patients is ethically permissible in certain clinical situations but requires specific consent from relatives if the patient's wish to donate is not clear. If no evidence of a patient's wish to donate is available, OP-ECMO is not recommended. In countries with presumed consent legislation, failure to opt out should be considered as a positive wish to donate. If a patient is not-yet brain-dead or is undergoing testing for brain death, OP-ECMO is not recommended. Further research on OP-ECMO is needed to better understand the attitudes of professionals, families, and lay people to ensure agreement on key ethical issues.

The transatlantic divide over brain death determination and the debate.

In 1976, the Royal College of Physicians published neurological criteria of death. The memorandum stated that-after preconditions and exclusion criteria were met-the absence of brainstem function, including apnoea testing, would suffice. In the USA, many experts felt that brain death could be only determined by demonstrating death of the entire brain. In the history of further refinement of UK and USA brain death criteria, one particular period stands out that would bring about an apparent transatlantic divide. On 13 October 1980, the British Broadcasting Corporation aired a programme entitled 'Transplants: Are the Donors Really Dead?' Several United States experts not only disagreed with the United Kingdom criteria, but claimed that patients diagnosed with brain death using United Kingdom criteria could recover. The fallout of this television programme was substantial, as indicated by a media frenzy and a 6-month period of heated correspondence within The Lancet and The British Medical Journal. Members of the Parliament questioned the potential long-term effect on the public's trust in organ transplantation. Given the concerns raised, the British Broadcasting Corporation commissioned a second programme, which was broadcast on 19 February 1981 entitled 'A Question of Life or Death: The Brain Death Debate.' Two panels debated the issues on the accuracy of the electroencephalogram and its place, the absolute need for assessing preconditions before an examination, the problems with recognition of toxins and the feasibility of doing a new prospective study in the United Kingdom, which would follow patients' examination assessed with United Kingdom criteria until cardiac standstill. The positions of the United States and United Kingdom remained diametrically opposed to each other. This article revisits this landmark moment and places it in a wider historical context. In the USA, the focus was not on the brainstem, and the definition of brain death became rapidly infused with terms such as whole brain death (all intracranial structures above the foramen magnum), cerebral death (all supratentorial structures) or higher brain death (cortical structures) virtually synonymous with persistent vegetative state. This review also identifies the fortitude of neurosurgeon Bryan Jennett and neurologist Christopher Pallis by introducing new corroborative data on the diagnosis of brain death and clarifying the United Kingdom position. Both understood that brainstem death was the infratentorial consequence of a supratentorial catastrophe. With the 1995 American Academy of Neurology practice parameters, the differences between the UK and USA brain death determination would become much less apparent.

Regional ethics of surgeon resuscitation for organ transplantation after lethal injury.

BACKGROUND: Trauma patients may present with nonsurvivable injuries, which could be resuscitated for future organ transplantation. Trauma surgeons face an ethical dilemma of deciding whether, when, and how to resuscitate a patient who will not directly benefit from it. As there are no established guidelines to follow, we aimed to describe resuscitation practices for organ transplantation; we hypothesized that resuscitation practices vary regionally. METHOD: Over a 3-month period, we surveyed trauma surgeons practicing in Levels I and II trauma centers within a single state using an instrument to measure resuscitation attitudes and practices for organ preservation. Descriptive statistics were calculated for practice patterns. RESULTS: The survey response rate was 51% (31/60). Many (81%) had experience with resuscitations where the primary goal was to preserve potential for organ transplantation. Many (90%) said they encountered this dilemma at least monthly. All respondents were willing to intubate; most were willing to start vasopressors (94%) and to transfuse blood (84%) (range, 1 unit to >10 units). Of respondents, 29% would resuscitate for ≥24 hours, and 6% would perform a resuscitative thoracotomy. Respect for patients' dying process and future organ quality were the factors most frequently considered very important or important when deciding to stop or forgo resuscitation, followed closely by concerns about excessive resource use. CONCLUSION: Trauma surgeons' regional resuscitation practices vary widely for this patient population. This variation implies a lack of professional consensus regarding initiation and extent of resuscitations in this setting. These data suggest this is a common clinical challenge, which would benefit from further study to determine national variability, areas of equipoise, and features amenable to practice guidelines.

Beyond the 'embryo question': human embryonic stem cell ethics in the context of biomaterial donation in the UK.

Discussion about the ethics of human embryonic stem cell (ESC) research in the UK tends to be dominated by the divisive and potentially intractable issue of the moral status of the embryo. This can have the effect of silencing or marginalizing other concerns, especially in the context of public engagement with science in this field. One such area of potential public concern is the donation of oocytes and embryos to stem cell research. Contemporary research on the views of donors and potential donors about a wide range of biomaterials, from solid organs to gametes and bone marrow, is reviewed and used to illustrate the range and types of ethical concerns articulated by this important group of stakeholders. Attitudes to donation are found to vary according to the type of tissue being donated or collected, the purpose for which donation is being sought and the nature of the recipient of the donation. Pertinently, attitudes towards donating oocytes are found to differ in some respects from donation of embryos or fetal tissue. The implications of these findings for ensuring ethically robust informed consent and publicly acceptable sourcing of human biomaterials for stem cell research are then considered.

Head Transplantation: The Ultimate Level that Medicine has not yet Achieved.

The process of head transplantation is reviewed according to Cartesian philosophy. Recent developments in head transplantation were followed with great interest in the media and society. The surgeon Sergio Canavero stated that he could perform head transplantation. His ethical approaches to the procedure are evaluated, and the methodological suitability of the procedure with regard to the scientific ethics is discussed. The perception of the head transplantation process in the media and society is described as a phenomenon, and the relationship between society and science is evaluated. Ethical duties and responsibilities are highlighted as an area of knowledge. According to the perspective of Cartesian philosophy, it is not yet possible to perform head transplantation under the conditions of today’s medicine.

The European protocol on organ transplant: key issues.

What is interesting in the philosophy of the European Protocol is the search of a balanced position which acknowledges the medical progress brought by organ transplants and considers the necessity to ensure that human dignity and individual freedom are respected. However, the principles adopted for such regulations at the European level leave on some major issues a great margin of appreciation to the domestic legislation. This is particularly true in areas such as defining death or consenting to organ transplants including the situation of minors and the role of the family. A last point should also be stressed regarding the European protocol: its lack of efficiency concerning a neglected but important issue: organ trafficking.

From Experimental Technique to Clinical Practice: Which Pathway in Transplant Surgery?

The question of whether a medical procedure is to be considered experimental or routine practice has enormous practical implications. In transplant surgery, as compared with pharmacologic clinical trials, the transition from experimental procedure to normal care is far from clear cut. Clinical trials comprise 4 well-established phases of evaluation going from phase I, aimed at assessing safety and identifying side effects in a few healthy volunteers, to phase IV, which involves entire populations and is aimed at long-term postmarketing surveillance. In transplant surgery, technical progress and experimentation follow more atypical and individual routes. As compared with pharmacologic research, the decision about "routine practice readiness" of a surgical procedure does not rely on a standardized formal act but rather on experts' capacity to find a consensus based on best practices and on ad-hoc criteria as well. Independent assessment by a panel of experts and oversight by an institutional review board are key to facilitating meaningful protection of transplant recipients and allowing the research to go forward. The framework of the human subjects protection regulations should also consider the transplant of organs that have previously been part of a research project.

Uterus transplant: evidence and ethics.

Absolute uterine infertility affects millions of women in the United States and more throughout the world. For instance, each year in the United States about 5,000 hysterectomies are performed in women under the age of 24. In total, nearly 9 million women of reproductive age have had a hysterectomy. Based on fecundity rates, thousands of these women may be candidates for uterus transplantation. An ongoing study enrolling some of these potential recipients onto a uterus transplant "waiting list" has revealed that most of these women have Rokitansky syndrome, hysterectomy secondary to endometriosis, cervical cancer, or compelling personal accounts justifying their candidacy. Fertility restoration by uterus transplantation was derived from fertility preservation research, including the development of the radical trachelectomy, oxygenation and perfusion of the in situ uterus, and work with organ donor networks. A decade of modern animal research set the foundation for this human work. Ongoing experiments include stable, long-term large animal allografts for investigating immunosuppression regimens and other transplantation details. Each of the animal models has contributed to the current knowledge base. Recently, nonhuman primates have been used to further investigate the possibility of human uterus transplantation. Nonhuman primate anatomy is analogous to that of humans with notable exceptions. The first human uterus transplant surgery took place in 2000, but it did not result in a pregnancy. However, taken in total, the magnitude of the intervening work from multiple groups throughout the world has made uterus transplantation a topic for discussion. It may also soon be a reality.

[Neuroethics of body transplantation]. / Neuroetica del trasplante de cuerpo.

INTRODUCTION: Recent contributions to the specialised literature address the topic of body transplantation, mostly produced by Sergio Canavero and a group of researchers from China. For several years they have been announcing that they will carry out the procedure, but it has still not been performed. AIMS: The aim of this study is to perform a neuroethical analysis of body transplantation, based on the methodology of Diego Gracia on ethics and bioethics and an analysis of facts, values and duties. Furthermore, we also propose that, with the knowledge available today, body transplantation must be addressed from the perspective of research ethics. DEVELOPMENT: As regards the facts, it can be said that, although the history of attempts to perform a body transplant dates back almost a century, there are many limitations preventing it from being performed with our current knowledge. This is due to the fact that no serious and rigorous preclinical research has been conducted (at most some anecdotal data can be found). With the data that is available, it does not even seem possible to think of designing a protocol to include human beings for body transplantation. In terms of values, according to the model developed by Emanuel, who proposes eight requirements that must be met to comply with the ethics of clinical research, it is not even possible to comply with one of them. Regarding duties, it would be wise to recommend that such a procedure should not be carried out on humans. CONCLUSIONS: Considering the scientific knowledge currently available and the values of research ethics, a body transplantation should not be performed in human beings either as clinical research or as clinical practice.

TITLE: Neuroetica del trasplante de cuerpo.Introduccion. Existe bibliografia reciente en revistas especializadas acerca del trasplante de cuerpo, generada fundamentalmente por Sergio Canavero y un grupo chino. Desde hace un par de años vienen anunciando que realizaran el procedimiento, pero aun no ha ocurrido. Objetivo. Realizar un analisis neuroetico sobre el trasplante de cuerpo, proponiendo la metodologia de Diego Gracia en etica y bioetica analizando hechos, valores y deberes. Se propone ademas que, con el conocimiento actual, el trasplante de cuerpo debe tratarse desde la etica de la investigacion. Desarrollo. Aunque desde hace casi un siglo hay antecedentes de intentar conseguir un trasplante de cuerpo, existen numerosas limitaciones para poder realizarlo con el conocimiento actual porque no hay investigacion preclinica seria y rigurosa (se encuentran a lo sumo datos anecdoticos). Con los datos disponibles, ni siquiera parece que pueda pensarse en el diseño de un protocolo de inclusion de seres humanos para el trasplante de cuerpo. En cuanto a valores, atendiendo al modelo de Emanuel, quien propone ocho requisitos para cumplir con la etica de la investigacion clinica, no es posible siquiera cumplir uno cabalmente. Lo mas prudente es recomendar que no debe realizarse un procedimiento asi en seres humanos. Conclusiones. Considerando el conocimiento cientifico disponible y los valores de la etica de la investigacion, no debe realizarse un trasplante de cuerpo en seres humanos, ni como investigacion clinica ni mucho menos como practica clinica.

Facial Disfigurement and Identity: A Review of the Literature and Implications for Facial Transplantation.

Facial disfigurement can significantly affect personal identity and access to social roles. Although conventional reconstruction can have positive effects with respect to identity, these procedures are often inadequate for more severe facial defects. In these cases, facial transplantation (FT) offers patients a viable reconstructive option. However, FT's effect on personal identity has been less well examined, and ethical questions remain regarding the psychosocial ramifications of the procedure. This article reviews the literature on the different roles of the face as well as psychological and social effects of facial disfigurement. The effects of facial reconstruction on personal identity are also reviewed with an emphasis on orthognathic, cleft, and head and neck surgery. Finally, FT is considered in this context, and future directions for research are explored.

[Human head transplantation].

Since the beginning of the 20th century, head transplantation (cephalosomatic anastomosis) has been studied in animal models including mice, rats and monkeys. A recently proposed protocol for head transplantation in humans has revived the interest for the procedure. However, key elements in the procedure, such as functional spinal cord fusion, sufficient neuroprotection and post-operative pain control are still undocumented. Ethical issues remain concerning the scientific validity of the proposed project as well as general concerns regarding the entire concept of human head transplantation.

40 projects in stem cell research, tissue engineering, tolerance induction and more (NRP46 "Implants and Transplants" 1999-2006).

Forty projects on stem cell research, tissue and matrix engineering, tolerance induction and other topics were supported by the Swiss National Research Program NRP46 (Implants, Transplants) from 1999-2006. The last project is devoted to developing stem cell lines from frozen surplus human embryos in Switzerland, which would otherwise have to be destroyed at the end of 2008. It is entitled JESP (Joint Embryonic Stem Cell Project) since it involves two Swiss universities, in vitro fertilisation centres and experts from the humanities (ethics and law) to handle this difficult problem. Over the years, stem cell transplantation and tissue/matrix engineering have drawn closer to each other and even developed synergies. Progress in stem cell research has been slower than anticipated, but a multitude of technical skills (phenotyping, isolation, transfection, induction of differentiation, labelling, expanding cells in culture, etc) were acquired. Understanding of stem cell biology has grown. The 7 projects on tissue and matrix engineering progressed closer to clinical applicability than the stem cell projects. Of 3 projects to implant encapsulated cells for the production of hormones (insulin, erythropoietin), one is close to clinical pilot studies with an advanced encapsulated device. Five projects were devoted to mechanisms of tolerance or the role of metzincins in chronic allograft nephropathy. Four studies in psychology and communication in transplantation were funded, as were 5 projects in ethics, law and the history of transplantation in Switzerland. The goal of NRP46 was to provide an impulse for research in these new fields and bring together experts from the humanities, biology and medicine to cope more effectively with the problems of regenerative medicine in the future. The majority of goals were attained, mainly in the basics.

Life in death: an overview of solid organ transplant in Shiraz, Iran.

Advances in organ preservation, immunosuppression, and surgical procedures have resulted in improved outcomes and survival rates. However, regarding organ transplant in different communities, these advances raise major ethical, policy, and religious issues. Transplant progress in Iran, in relation to the rest of the world, has been slow at times and quick during others. Between 1988 and 1993, there was a rapid surge in experiments with tissue transplant in Iran, and the Shiraz Organ Transplantation Center, established in 1988, rose to become a pioneer of the most significant improvements, a leading center for organ transplant, and the only center for liver transplant in Iran. In this article, we review milestones in the development of a successful organ transplant program and implementation of legislation in Iran. The Shiraz model of transplant is a new program that attempts to overcome the problems of organ shortage. We provide a description of the Iranian model of transplant and its restrictions and examine the most promising future trends in this exciting field.

Transplanting the Body: Preliminary Ethical Considerations.

A dissociated area of medical research warrants bioethical consideration: a proposed transplantation of a donor's entire body, except head, to a patient with a fatal degenerative disease. The seeming improbability of such an operation can only underscore the need for thorough bioethical assessment: Not assessing a case of such potential ethical import, by showing neglect instead of facing the issue, can only compound the ethical predicament, perhaps eroding public trust in ethical medicine. This article discusses the historical background of full-body transplantation, documents the seriousness of its current pursuit, and builds an argument for why prima facie this type of transplant is bioethically distinct. Certainly, this examination can only be preliminary, indicating what should be a wide and vigorous discussion among practitioners and ethicists. It concludes with practical suggestions for how the medical and bioethics community may proceed with ethical assessment.

Fetal listing for organ transplantation in Canada.

This article presents an ethical and legal examination of whether a fetus should be listed to receive a transplanted organ. To date, relatively little discussion of this question has found its way into either the clinical or ethics literature. This article is divided into four sections. The first section analyzes the most common reasons against fetal listing offered by the nonclinicians with whom the author spoke. The two reasons involve the legal concepts of rights and best interests. Pivotal ethical foundations of the Canadian health system are also discussed so as to help develop a compatible allocation process for Canadian transplant programs. The second section analyzes common concerns raised in the author's discussions with clinicians. The third section presents four cardiac transplant scenarios to illustrate how relevant and sequential criteria for deciding whether, and in what circumstances, an available heart can be defensibly allocated to a fetus. The last section summarizes the decision process that reflects the preceding sections' analysis. Recognizing that the four scenarios do not exhaust the likely situations wherein a fetus and an infant might qualify for the same organ, the article closes with a recommendation that it be considered a catalyst for further analysis.