Cadaver organs should be automatically availableThe shortage of donor organs and tissue for transplantation constitutes an acute emergency which demands radical rethinking of our policies and radical measures. While estimates vary and are difficult to arrive at there is no doubt that the donor organ shortage costs literally hundreds of thousands of lives every year. “In the world as a whole there are an estimated 700 000 patients on dialysis . . .. In India alone 100 000 new (...) patients present with kidney failure each year” . Almost “three million Americans suffer from congestive heart failure . . . deaths related to this condition are estimated at 250 000 each year . . . 27 000 patients die annually from liver disease . . .. In Western Europe as a whole 40 000 patients await a kidney but only . . . 10 000 kidneys”1 become available. Nobody knows how many people fail to make it onto the waiting lists and fail to register in the statistics. “As of 24th November 2002 in the United Kingdom 667 people have donated organs, 2055 people have received transplants, and 5615 people are still awaiting transplants.”2Conscious of the terrible and unnecessary tragedy that figures like these represent I have been advocating for more than 20 years now some radical measures to stem this appalling waste of human life. The measure which is the subject of Hamer and Rivlin’s paper 3 concerns the automatic availability of all cadaver organs—a measure, which I first advocated publicly in 1983.4THE AUTOMATIC AVAILABILITY OF DONOR ORGANSWe need to begin by being clear about just what it is I propose and why. At the moment in the United Kingdom we …. (shrink)

The use of human tissue raises ethical issues of great concern to health care professionals, biomedical researchers, ethics committees, tissue banks and policy makers because of the heightened importance given to informed consent and patient autonomy. The debate has been intensified by high profile scandals such as the “baby hearts” debacle and revelations about the retention of human brains in neuropathology laboratories worldwide. Respect for patient’s rights seems, however, to impede research and development of clinical knowledge in contemporary (...) health care. The Common clinical endeavour argument and a Presumption for beneficial use argument suggest that the use of tissues for research and teaching in contemporary health care can respect patients and their values in multicultural communities where there are provisions for oversight and for opting not to contribute, both of which should respect the diverse views of different ethnic or cultural groups. (shrink)

The shortage of organs for transplantation by its nature prompts ethical dilemmas. For example, although there is an imperative to save human life and reduce suffering by maximising the supply of vital organs, there is an equally important obligation to ensure that the process by which we increase the supply respects the rights of all stakeholders. In a relatively unexamined practice in the USA, organs are procured from unrepresented decedents without their express consent. Unrepresented decedents have no known healthcare wishes (...) or advance care planning document; they also lack a surrogate. The Revised Uniform Anatomical Gift Act (RUAGA) of 2006 sends a mixed message about the procurement of organs from this patient population and there are hospitals that authorise donation. In addition, in adopting the RUAGA, some states included provisions that clearly allow organ procurement from unrepresented decedents. An important unanswered question is whether this practice meets the canons of ethical permissibility. The current Brief Report presents two principled approaches to the topic as a way of highlighting some of the complexities involved. Concluding remarks offer suggestions for future research and discussion. (shrink)

Background Requirements for organ donation after cardiac or imminent death have been introduced to address the transplantable organs shortage in the United States. Organ procurement organizations (OPOs) increasingly use the Internet for organ donation consent. Methods An analysis of OPO Web sites available to the public for enrollment and consent for organ donation. The Web sites and consent forms were examined for the minimal information recommended by the United States Department of Health and Human Services (...) for informed consent. Content scores were calculated as percentages of data elements in four information categories: donor knowledge, donor consent reinforcement, donation promotion, and informed consent. Results There were 60 Web sites for organ donation enrollment serving the 52 states. The median percent (10 percentile-90 percentile) content scores of the Web sites for donor knowledge, donor consent reinforcement, and donation promotion were 33% (20–47), 79% (57–86), and 75% (50–100), respectively. The informed consent score was 0% (0–33). The content scores for donor knowledge and informed consent were significantly lower than donor consent reinforcement and donation promotion for all Web sites (P < .05). The content scores for the four categories were similar among the 11 regions of the United Network for Organ Sharing. Conclusion The Web sites and consent forms for public enrollment in organ donation do not fulfill the necessary requirements for informed consent. The Web sites predominantly provide positive reinforcement and promotional information rather than the transparent disclosure of organ donation process. Independent regulatory oversight is essential to ensure that Internet enrollment for organ donation complies with legal and ethical standards for informed consent. (shrink)

Background Consent policies for post-mortem organ procurement (OP) vary throughout Europe, and yet no studies have empirically evaluated the ethical implications of contrasting consent models. To fill this gap, we introduce a novel indicator of governance quality based on the ideal of informed support, and examine national differences on this measure through a quantitative survey of OP policy informedness and preferences in seven European countries. -/- Methods Between 2017–2019, we conducted a convenience sample survey of students (n = (...) 2006) in Austria (AT), Belgium (BE), Denmark (DK), Germany (DE), Greece (GR), Slovenia (SI) and Spain (ES), asking participants about their donation preferences, as well as their beliefs and views about the policy in place. From these measures, we computed indices of informedness, policy support, and fulfilment of unexpressed preferences, which we compared across countries and consent systems. -/- Results Our study introduces a tool for analyzing policy governance in the context of OP. Wide variation in policy awareness was observed: Most respondents in DK, DE, AT and BE correctly identified the policy in place, while those in SI, GR and ES did not. Respondents in opt-out countries (AT, BE, ES and GR) tended to support the policy in place (with one exception, i.e., SI), whereas those in opt-in countries (DE and DK) overwhelmingly opposed it. These results reveal stark differences in governance quality across countries and consent policies: We found a preponderance of informed opposition in opt-in countries and a general tendency towards support–either informed or uninformed–in opt-out countries. We also found informed divergence in opt-in countries and a tendency for convergence–either informed or uninformed–among opt-out countries. -/- Conclusion Our study offers a novel tool for analyzing governance quality and illustrates, in the context of OP, how the strengths and weaknesses of different policy implementations can be estimated and compared using quantitative survey data. (shrink)

With the case of Belgium as a negative example, this paper will evaluate the legitimacy of using mentally incompetents as organ sources. The first section examines the underlying moral dilemma that results from the necessity of balancing the principle of respect for persons with the obligation to help people in desperate need. We argue for the rejection of a radical utilitarian approach but also question the appropriateness of a categorical prohibition. Section two aims to strike a fair balance between (...) the competing interests at stake and to define the conditions under which organ harvest from mentally incompetents might be morally acceptable. To this end, we morally assess the main requirements that have been put forward to allow organ removal from incompetent donors. We conclude that the current Belgian legislation is far too permissive and that national regulations that do not permit the harvest of non-regenerable organs from mentally incompetents in exceptional circumstances are too restrictive. On the basis of this discussion, we propose a number of guiding principles for decision-making in this area. (shrink)

Globally active companies are involved in the discursive construction of moral legitimacy. Establishing normative conformance is problematic given the plurality of norms and values worldwide, and is particularly difficult for companies operating in morally controversial industries. In this paper, we investigate how organizations publicly legitimize the trade of human tissue for private profit when this practice runs counter to deep-seated and widespread moral beliefs. To do so, we use inductive, qualitative methods to analyze the website discourse of three types (...) of organizations that trade in human tissue and are associated with different degrees of moral controversy with respect to tissue procurement and use. Our analysis reveals an object-oriented approach to moral legitimizing centered on the human tissue as a morally disputed good. We find that the website discourse translates human tissue into technology, constructs normative meaning around a dominant instrumental value associated with human-tissue-as-technology, and reproduces and stabilizes this meaning by six discursive mechanisms that amplify and anchor it. Moreover, the use of amplifying and anchoring discourse was greater in organizations associated with greater controversy. The results are consistent with an object-oriented sociality. (shrink)

In 2015 Robert Veatch published the second edition of his Transplantation ethics, this time together with Lainie Ross. The chapters on postmortem organ procurement distinguish between ‘giving’ and ‘taking’ systems, and argue that ‘taking’ systems may promise a greater yield of organs for transplantation, but inevitably violate a requirement of respect for the deceased's autonomy. That argument has been very influential, and is also representative of a way of thinking that is widespread in the literature and in public (...) debate. In this paper I contend that it is conceptually flawed in a number of important respects. These concern the understanding of both the concept of ‘consent’ and the requirement of respect for autonomy, the role of the relatives in any procurement system, and the factors that actually determine the extent to which a system respects autonomy, under any interpretation of that requirement. (shrink)

Over 90% of the organs transplanted in China before 2010 were procured from prisoners. Although Chinese officials announced in December 2014 that the country would completely cease using organs harvested from prisoners, no regulatory adjustments or changes in China’s organ donation laws followed. As a result, the use of prisoner organs remains legal in China if consent is obtained. We have collected and analysed available evidence on human rights violations in the organ procurement practice in China. We (...) demonstrate that the practice not only violates international ethics standards, it is also associated with a large scale neglect of fundamental human rights. This includes organ procurement without consent from prisoners or their families as well as procurement of organs from incompletely executed, still-living prisoners. The human rights critique of these practices will also address the specific situatedness of prisoners, often conditioned and traumatized by a cascade of human rights abuses in judicial structures. To end the unethical practice and the abuse associated with it, we suggest to inextricably bind the use of human organs procured in the Chinese transplant system to enacting Chinese legislation prohibiting the use of organs from executed prisoners and making explicit rules for law enforcement. Other than that, the international community must cease to abet the continuation of the present system by demanding an authoritative ban on the use of organs from executed Chinese prisoners. (shrink)

In the latter half of the twentieth century, developed countries of the world have made tremendous strides in organ donation and transplantation. However, in this area of medicine, Japan has been slow to follow. Japanese ethics, deeply rooted in religion and tradition, have affected their outlook on life and death. Because the Japanese have only recently started to acknowledge the concept of brain death, transplantation of major organs has been hindered in that country. Currently, there is a dual definition (...) of death in Japan, intended to satisfy both sides of the issue. This interesting paradox, which still stands to be fully resolved, illustrates the contentious conflict between medical ethics and medical progress in Japan. (shrink)

BackgroundEvolving medical technology, advancing biomedical and drug research, and changing laws and legislation impact patients’ healthcare options and influence healthcare practitioners’ (HCPs’) practices. Conscientious objection policy confusion and variability can arise as it may occasionally be unclear what underpins non-participation. Our objective was to identify, analyze, and synthesize the factors that influenced HCPs who did not participate in ethically complex, legally available healthcare.MethodsWe used Arksey and O’Malley’s framework while considering Levac et al.’s enhancements, and qualitatively synthesized the evidence. We searched (...) Medline, CINAHL, JSTOR, EMBASE, PsychINFO, Sociological Abstracts, and ProQuest Dissertations and Theses Global from January 1, 1998, to January 15, 2020, and reviewed the references of the final articles. We included articles written in English that discussed the factors that influenced physicians and registered nurses (RNs) who did not participate in end-of-life (EOL), reproductive technology and health, genetic testing, and organ or tissue donation healthcare areas. Using Covidence, we conducted title and abstract screening, followed by full-text screening against our eligibility criteria. We extracted the article’s data into a spreadsheet, analyzed the articles, and completed a qualitative content analysis using NVivo12.ResultsWe identified 10,664 articles through the search, and after the screening, 16 articles were included. The articles sampled RNs (n = 5) and physicians (n = 11) and encompassed qualitative (n = 7), quantitative (n = 7), and mixed (n = 2) methodologies. The care areas included reproductive technology and health (n = 11), EOL (n = 3), organ procurement (n = 1), and genetic testing (n = 1). One article included two care areas; EOL and reproductive health. The themed factors that influenced HCPs who did not participate in healthcare were: (1) HCPs’ characteristics, (2) personal beliefs, (3) professional ethos, 4) emotional labour considerations, and (5) system and clinical practice considerations.ConclusionThe factors that influenced HCPs’ who did not participate in ethically complex, legally available care are diverse. There is a need to recognize conscientious objection to healthcare as a separate construct from non-participation in healthcare for reasons other than conscience. Understanding these separate constructs will support HCPs’ specific to the underlying factors influencing their practice participation. (shrink)

Presumed consent to organ donation looks increasingly unlikely to be a palatable option for increasing organ procurement in the UK following the publication of the report into events at Alder Hey and elsewhere. Yet, given that the alternative to increasing the number of cadaveric organs available is either to accept a greater number of live donations, or accept that people will continue to die for the want of an organ, public policy makers remain obliged to consider (...) other means of increasing the procurement rate.In this paper, we meet the main objections to mandated choice . We have modified the traditional approach to mandated choice to take into account the force of the objection that mandated donation is preferable, by accepting that people can and do make bad decisions about organ donation and proposing that all accompanying public education and information about cadaveric donation should be directed in favour of donation. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 13.1 (2003) 51-52 [Access article in PDF] Congress Considers Incentives for Organ Procurement Alexander S. Curtis [Tables]During the 108th Congressional session, several bills pertaining to ethical incentives for organ donation likely will be introduced. In some cases, they will be similar to bills before the 107th Congress (see Table 1). Bills in both the House of Representatives and the Senate address (...) the establishment and maintenance of donor registries, financial reimbursements for medical and nonmedical expenses incurred by qualifying donors, the presentation of commemorative medals, and tax credits.A bill entitled "Gift of Life Congressional Medal Act" (introduced last year by Senate majority leader Bill Frist (R-TN) as Senate Bill 325), and its corresponding bill of the same title (passed in the House of Representatives last year as H.R. 708), would establish a congressional commemorative medal honoring "any organ donor, or the family or family member of any organ donor." The medal is to be designed and struck with "suitable emblems, devices, and inscriptions" by the Secretary of the Treasury. The eligible donor or donor's family member would be presented with the medal by the Secretary of Health and Human Services. This bill would establish qualifying donations as those of human kidneys, livers, hearts, lungs, pancreases, or any other organ, but excludes corneas and eyes.Another bill, introduced by Representative Michael Bilirakis (R-FL) entitled "Organ Donation Improvement Act" (H.R. 624), would award grants or contracts to states, transplant centers, and qualified organ procurement organizations for the purpose of providing travel, subsistence, and incidental nonmedical expenses to individuals who make living donations. In order to receive reimbursement, the donating individuals must reside in states other than the states in which the intended recipients reside and the annual income of those receiving the organs cannot exceed $35,000. The bill also would appropriate $15,000,000 to make grants to states and public and nonprofit entities for the purpose of carrying out studies, public education demonstrations, and outreach activities "designed to increase the number of organ donors within the state." The bill would be effective from time of enactment through 2005. [End Page 51]Two other bills proposed within the House of Representatives in 2002 called for amendment to the Internal Revenue Code. The "Gift of Life Tax Credit Act (introduced as H.R. 1872 by Representative James Hansen (R-UT)) and the "Help Organ Procurement Expand Act" (introduced as H.R. 2090 by Representative Chris Smith (R-NJ)) present a refundable credit to individuals or to the estates of those who agree either to be living donors or to donate their organs upon death. The "Gift of Life Tax Credit Act" refunds $10,000 to the estates of eligible individuals "for the taxable year which includes the date of the individual's death." The "Help Organ Procurement Expand Act" offers a refund of $2,500 to qualified persons. Donations of kidneys, livers, pancreases, islet cells, lungs, and intestines are accepted, however several conditions restrict permissible donors. The "Gift of Life Tax Credit Act" requires that the legally competent individual's death not be due to a suicide and that the intention to donate was clearly declared. The "Help Organ Procurement Expand Act" prohibits donations from individuals who were killed with physician assistance, died as a result of a suicide, have been indicted or convicted of a felony or a misdemeanor offense, or are actively under criminal investigation for a possible felony offense. The "Help Organ Procurement Expand Act" also restricts procuring organs from unborn children or human fetuses and under circumstances in which the living donor would be subject to "unacceptable levels of medical risk of death or permanent debilitation." Alexander S. Curtis is a research assistant at the Kennedy Institute of Ethics, Georgetown University, Washington, DC. He received his bachelor's degree from Miami University.... (shrink)

In defending what he calls ‘full-blooded Epicureanism’, James Stacey Taylor argues that the dead cannot be harmed or wronged.1 This has implications for a range of bioethical issues pertaining to death, including posthumous organ procurement. Taylor claims that respecting the autonomy of persons requires that their desires regarding the treatment of their postmortem bodies be given due consideration while these persons are alive. It is not obvious what this means in practical terms, though Taylor says that respect for (...) autonomy requires that these wishes be recorded with the intention that they be followed. Yet if respect for autonomy only applies to the wishes of premortem persons, and if there are no posthumous harms or wrongs, then it is not clear why it would matter morally whether one's wishes about what to do with one's organs were fulfilled or thwarted after one's death.Most of us have an interest in what happens to our bodies not just during our lives but also after our deaths. Personal sovereignty and autonomy give persons a right to control what happens to their bodies, and since the body …. (shrink)

In 2015 Robert Veatch published the second edition of his Transplantation ethics, this time together with Lainie Ross. The chapters on postmortem organ procurement distinguish between ‘giving’ and ‘taking’ systems, and argue that ‘taking’ systems may promise a greater yield of organs for transplantation, but inevitably violate a requirement of respect for the deceased's autonomy. That argument has been very influential, and is also representative of a way of thinking that is widespread in the literature and in public (...) debate. In this paper I contend that it is conceptually flawed in a number of important respects. These concern the understanding of both the concept of ‘consent’ and the requirement of respect for autonomy, the role of the relatives in any procurement system, and the factors that actually determine the extent to which a system respects autonomy, under any interpretation of that requirement. (shrink)

Harsh medicine -- Life unworthy of life -- The price of autonomy -- Creating a duty to die -- Organ donors or organ farms? -- Putting second things first -- Two legs good, four legs better.

Organ donation after brain death has been practiced in China since 2003 in the absence of brain death legislation. Similar to international standards, China’s brain death diagnostic criteria include coma, absence of brainstem reflexes, and the lack of spontaneous respiration. The Chinese criteria require that the lack of spontaneous respiration must be verified with an apnea test by disconnecting the ventilator for 8 min to provoke spontaneous respiration. However, we have found publications in Chinese medical journals, in which the (...) donors were declared to be brain dead, yet without an apnea test. The organ procurement procedures started with initiating “intratracheal intubation for mechanical ventilation after brain death,” indicating that a brain death diagnosis was not performed. The purpose of the intubation was not to resuscitate the patient but rather was directly related to facilitating the explantation of organs. Moreover, it was unmistakably stated in two of these publications that the cardiac arrest was induced in these patients without brain death determination by cold St. Thomas cardioplegic solution or other cold myocardial protection solutions. This means that the condition of these donors neither met the criteria of brain death nor that of cardiac death. In other words, the “donor organs” may well have been procured in these cases from living human beings. Thus, brain death definition is abused in China by some individuals for organ harvesting, and a systematic investigation is needed to clarify the situation of organ donation after brain death in China. (shrink)

: The supply of organs for transplant remains inadequate to meet the needs of waiting patients, in spite of many programs and approaches to increase rates of donation. Over the years there have been numerous proposals to introduce schemes that would move toward the outright sale of organs. Three articles in this issue of the Journal propose methods for increasing organ supply—two by moving toward a market approach and the third by advocating a change in social culture. All three (...) suffer from shortcomings, including the endorsement and encouragement of the exploitation of those who may offer organs. Although the shortage of organs must be addressed, the social price of a market in organs is too high, and proposals to encourage a rethinking of social responsibility are unlikely to be effective. (shrink)

Organ procurement organization (OPO) staff play an essential role in the facilitation of organ donation as they guide family members and loved ones of dying patients through the donation process. Throughout the donation process, OPO staff must assume the role of a dual advocate, considering both the interests of the donor (which often include the wishes of the donor’s family) and the interests of potential recipient(s). The benefits of this role are well established; however, minimal literature exists (...) on the ways this role can cause moral distress in OPO staff, who frequently face scenarios in which adhering to the wishes of a donor family may compromise donation potential but failing to honor donor family requests may result in further emotional burden for the family. Given the frequency with which these ethically complex situations exist during donation, OPO staff are at heightened risk for experiencing moral distress and burnout, yet they are seldom acknowledged in the existing moral distress literature. As a result, it is unclear whether the current practices available to mitigate moral distress are beneficial for this population. (shrink)

In December 2015, Wales became the first country in the UK to move away from an opt-in system in organ procurement. The new legislation introduces the concept of deemed consent whereby a person who neither opt in nor opt out is deemed to have consented to donation. The data released by the National Health Service in July 2017 provide an excellent opportunity to assess this legislation in light of concerns that it would decrease procurement rates for living (...) and deceased donation, as well as sparking an increase in family refusals. None of these concerns have come to pass, with Wales experiencing more registered donors, fewer family refusals and more living donations. However, as the number of actual donors has dropped slightly from a high level, the situation must be monitored closely in the years to come. (shrink)

In 2008 the Australian Government introduced a national reform agenda to increase organ and tissue donation. Australia continues to perform poorly by international standards on measures of organ procurement, however. This paper outlines three proposals to improve donation rates and considers the empirical evidence available for each. A number of ethical objections frequently given to resist such proposals are also addressed. Firstly, it is recommended that Australia implement an ‘opt-out’ system of organ donation. Secondly, the (...) existing veto rules should be changed to better protect the wishes of those who wish to donate. Finally, a numer of incentives should be offered to increase donation rates; these could include incentives of financial value, but also non-financial incentives such as prioritisation for the receipt of organs for previous donors. (shrink)

: Free-market libertarians have long supported incentives to increase organ procurement, but those oriented to justice traditionally have opposed them. This paper presents the reasons why those worried about justice should reconsider financial incentives and tolerate them as a lesser moral evil. After considering concerns about discrimination and coercion and setting them aside, it is suggested that the real moral concern should be manipulation of the neediest. The one offering the incentive (the government) has the resources to eliminate (...) the basic needs that pressure the poor into a willingness to sell. It is unethically manipulative to withhold those resources and then offer payment for organs. Nevertheless, the poor have been left without basic necessities for 20 years since the passage of the prohibition on incentives. As long as the government continues to withhold a decent minimum of welfare, liberals should, with shame, cease opposing financial incentives for organ procurement. (shrink)

The author explores different views of the significance of the human body and contrasts those which regard it as a commodity or personal possession with those which stress its moral value as integral to the personal identity of individuals. This study provides background to many of the controversies in medical ethics.

Altruism and solidarity are concepts that are closely related to organ donation for transplantation. On the one hand, they are typically used for encouraging people to donate. On the other hand, they also underpin the regulations in force in each country to different extents. They are often used indistinctly and equivocally, despite the different ethical implications of each concept. This paper aims to clarify to what extent we can speak of altruism and solidarity in the predominant models of (...) class='Hi'>organ donation. It also raises the ethical question of whether these categories are adequate as a basis for such models, bearing in mind that organs are a scarce resource and that a shortage of them may mean that fewer lives are saved or improved. (shrink)

Richard Thaler and Cass Sunstein (2008) contend that mandated choice is the most practical nudge for increasing organ donation. We argue that they are wrong, and their mistake results from failing to appreciate how perceptions of meaning can influence people's responses to nudges. We favor a policy of default to donation that is subject to immediate family veto power, includes options for people to opt out (and be educated on how to do so), and emphasizes the role of (...) class='Hi'>organ procurement organizations and in-house transplant donation coordinators creating better environments for increasing the supply of organs and tissues obtained from cadavers. This policy will provide better opportunities for offering nudges in contexts where in-house coordinators work with families. We conclude by arguing that nudges can be introduced ethically and effectively into these contexts only if nudge designers collaborate with in-house coordinators and stakeholders. (shrink)

Organ shortage constitutes an unsolved problem for every country that offers transplantation as a therapeutic option. Besides the largely implemented donation model and the eventually implemented market model, a theorized automatic organ procurement model has raised a rich debate in the legal, medical and bioethical community, since it could show a higher potential to solve organ shortage. In this paper, we study the main arguments for and against this model. We show how, in the light of (...) empirical data extracted from countries with a universal health care system, its implementation could lead to a positive impact on organ procurement rates. Three factors are envisioned as fundamental in the comprehension and a possible regulation of the automatic organ procurement model: the lack of recognition of the conscientious objection, the preservation of the right to choose end of life conditions, and the need to avoid incentives for families or healthcare professionals. (shrink)

Ex-vivo tissue engineering is an emerging medical technology. Its aim is to regenerate tissues and organs and to restore them to full physiological activity. Some clinical trials with human tissue engineered products have been conducted and others will follow. These trials not only have to confirm the therapeutic value of the HTEP, they also have to provide insight in its regenerative activity, its safety and long-term effects. The development of these trials is aggravated by the complexity of the (...) tissue engineering process and product. This paper investigates how this complexity influences the ethical conduct of clinical trials with HTEPs. We focus on the value and validity of the trial, the risk-benefit ratio and the protection of the trial participant. We argue that trials with HTEPs need a robust methodology. The risk-benefit ratio of a new HTEP must be determined and compared with available efficacious therapies. This requires the identification and minimisation of risks associated with tissue engineering. Finally a process as complex as tissue engineering presents serious challenges for the informed consent process, and for the protection of the trial participant during and after the trial. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause the research involves (...) the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 13.1 (2003) 53-64 [Access article in PDF] Incentives for Providing Organs Patricia Milmoe McCarrick and Martina Darragh After a contentious debate at its 2002 annual meeting, the American Medical Association's House of Delegates voted to endorse the opinion of its Council on Ethical and Judicial Affairs that the impact of financial incentives on organ donation should be studied (Josefson 2002). The shortage of (...) organs for transplantation has been an ongoing problem for more than 20 years. In June1981, Representative Philip Crane (R-IL) introduced legislation in the U.S. House of Representatives proposing a $25,000 income tax deduction and a $25,000 estate tax exclusion for donating an organ (Tax Incentives 1981). Still the National Organ Transplant Act enacted in October 1984 prohibited the offering of any "valuable consideration" in return for organs (United States 1984).The developments of a legal market for tissues in the United States and a black market for organs around the world have raised the question of whether donation without compensation is the only ethically viable option. Some critics of the current system claim reliance on donation actually promotes a black market in organs (Kaserman and Barnett 2002, p. 38; Palmer 1999, p. 36). In addition, a new set of compensation issues has arisen as living kidney donor transplantations begin to rival those performed with cadaveric organs (United States 2001).As a result, current suggestions for incentives go far beyond the traditional death benefit payment to include such ideas as medals of honor for donors, reimbursement for funeral expenses, exchange programs for organ donation, and special medical insurance for living organ donors. Numerous bills introduced into the 107th Congress have proposed such incentives (Delmonico et al. 2002.) In October 2002, the U.S. Department of Health and Human Services awarded $5.2 million in grants to study both clinical and behavioral interventions for increasing organ donations that do not involve incentives. The inspiration for some of the funded proposals comes from the successes of Spain's social services and the United Kingdom's clinical administration of organ procurement programs (Robeznieks 2002). [End Page 53]With a nod to evidence-based medicine, the underlying concern expressed in much of the current literature is that no idea for increasing the supply of organs should be discounted before it is studied. This bibliography provides a short introduction to the range of opinions expressed on the issue of incentives for providing organs.al-Mousawi, M.; Samhan, M.; al-Mezairee I.; Razzak, M.A.; and Khawari, F. Cadaver Organ Procurement in Kuwait. Transplantation Proceedings 31 (8): 3375-76, 1999.The authors describe a protocol that significantly increased cadaveric organ donation and credit it with fostering the expansion of an organ sharing program among the Arab Gulf states. Developed by Kuwaiti neurologists and anesthetists after a continuing education course on transplantation, the protocol places a special emphasis on the role of local transplant coordinators who facilitate the investigation of brain death cases by neurologists.Arnold, Robert; Bartlett, Steven; Bernat, James; et al. [Ethics Committee of the American Society of Transplant Surgeons] Financial Incentives for Cadaver Organ Donation: an Ethical Reappraisal. Transplantation 73 (8): 1361-67, 27 April 2002.To prepare for proposed studies of financial incentives for organ donation, the American Society of Transplant Surgeons convened a panel to develop a methodology for evaluating the ethics of such research. Comprised of organ procurement organization executives, physicians, surgeons, and ethicists, the panel generated a list of nine criteria for use in judging any incentives proposal. While opposed to direct payment or tax incentives for organ donation, a majority of the members support funeral expense reimbursement or charitable contributions as incentives that would not violate or undermine the ideal of altruism.Cameron, J. Stewart, and Hoffenberg, Raymond. The Ethics of Organ Transplantation Reconsidered: Paid Organ Donation and the Use of Executed Prisoners as Donors. Kidney International 55 (2): 724-32, February 1999.After reviewing arguments for and against payment for organ procurement, the authors apply these arguments to the specific case of obtaining organs from executed... (shrink)

This article tackles the current deficit in the supply of cadaveric organs by addressing the family veto in organ donation. The authors believe that the family veto matters—ethically as well as practically—and that policies that completely disregard the views of the family in this decision are likely to be counterproductive. Instead, this paper proposes to engage directly with the most important reasons why families often object to the removal of the organs of a loved one who has signed up (...) to the donor registry—notably a failure to understand fully and deliberate on the information and a reluctance to deal with this sort of decision at an emotionally distressing time. To accommodate these concerns it is proposed to separate radically the process of information, deliberation and agreement about the harvesting of a potential donor's organs from the event of death and bereavement through a scheme of advance commitment. This paper briefly sets out the proposal and discusses in some detail its design as well as what is believed to be the main advantages compared with the leading alternatives. (shrink)

In the United States, people may donate organs and tissues to a family member, friend, or anyone whose specific need becomes known to them. For example, in late 2003 dozens of people came forward to donate a kidney to a professional basketball player known to them only through his sports performances. People may also donate a kidney to no one in particular through a process known as nondirected donation. In nondirected donation, people donate a kidney to the organ allocation (...) system rather than to anyone known to them personally. There are limits, though, to generosity. People are usually not allowed to donate to groups of people, no matter the contours of the group, whether white, black, Catholic or Presbyterian, third-time liver recipient, and so on. As the agency that oversees national transplantation policy, the United Network for Organs Sharing does not allow this sort of restricted donation, though it appears that some regional Organ Procurement Organizations occasionally bend the rules when donors insist that their organs go to children or to first-time recipients. Those ad hoc arrangements are, however, the exception to the rule. (shrink)

Harold Jaffe argues that we should adopt opt-out testing for HIV. There are paternalistic and utilitarian arguments for such an approach. In this commentary I draw attention to some similarities between his arguments and debates about opt-out systems of organ donation. I argue that the status quo bias provides both part of the reason that opt-out approaches work, and an explanation for why such approaches are sometimes resisted.

In lieu of an abstract, here is a brief excerpt of the content:Back to the Future:Obtaining Organs from Non-Heart-Beating CadaversRobert M. Arnold (bio) and Stuart J. Youngner (bio)Organ Transplantation requires viable donor organs. This simple fact has become the Achilles' heel of transplantation programs. Progress in immunology and transplant surgery has outstripped the supply of available organs. Between 1988 and 1991, for example, the number of transplant candidates on waiting lists increased by about 55 percent, while the number of (...) donors increased only about 16 percent.1 By the end of March 1993, more than 30,000 potential recipients awaited transplantation (United Network for Organ Sharing Database (UNOS) 1993). Every day six of these patients die prior to receiving a heart or liver transplant, while patients needing kidney transplants must tolerate a lower quality of life on dialysis (Grenvik 1992; Evans, Orians, and Ascher 1992).This scarcity is likely to get worse. As transplantation becomes more successful, it is being offered to sicker and older patients. Attempts to transplant other solid organs, such as small bowel and pancreas, will only fuel the demand for donors. However, the current source of organs is unlikely to grow. Most organs come from patients who have been declared dead by neurologic criteria (commonly referred to as "brain dead" or heart-beating cadaver donors (HBCDs) because their hearts are beating at the time of procurement). Estimates of the potential pool of HBCDs have been revised downward from 20,000-27,000 to roughly 10,000-12,000 (Nathan et al. 1991). Improvements in automobile safety and handgun legislation will likely lead to further reductions. Moreover, the rate of procurement from HBCDs has remained relatively flat despite extensive public awareness campaigns and legislation requiring hospitals to routinely request donation from families of dead patients (Caplan et al. 1992).If organ transplantation is going to continue to flourish, alternative [End Page 103] sources of organs must be found. Recently the University of Pittsburgh Medical Center (UPMC) proposed procuring organs from patients who have been declared dead by traditional cardiopulmonary rather than brain-oriented criteria after they or their families have decided to forgo life-sustaining treatment—hereafter referred to as the Pittsburgh protocol (UPMC Policy 1993). These patients are typically referred to as non-heart-beating cadaver donors (NHBCDs) because their hearts are no longer beating at the time of organ procurement.Although NHBCDs were a major source of transplantable kidneys prior to the institution of death by neurologic criteria, their usefulness was limited by "warm ischemia time." This term refers to the injury to tissues that occurs when the blood supply is interrupted and before the organs are cooled and reperfused. Under the Pittsburgh protocol, therapy is withdrawn in the operating room where a waiting surgical team removes organs immediately after death is declared. By controlling the place and time of death, it has been possible to minimize warm ischemia time and thus solve the technical problems previously associated with procurement from NHBCDs.The potential contribution of NHBCD organs is significant. Nathan (1992), using data from Delaware Valley Transplant Program, concludes that the use of severely brain injured, but not "brain dead" patients, would increase the donor pool by 20-25 percent. Moreover, unpublished data from the Pittsburgh organ procurement organization, the Center for Organ Recovery and Education (CORE), suggests that these organs, particularly kidneys, function as well as those procured from HBCDs (Broznick 1993).This volume is devoted to the ethical, psychosocial, and public policy implications of procuring organs from non-heart-beating cadaver donors after a discussion to forgo life-sustaining treatment. The genesis of this volume was a project in which we invited leading experts in transplantation, ethics, and public policy to use the Pittsburgh protocol as a starting point for exploring a broad range of issues associated with attempts to procure organs from NHBCDs. The issues raised by NHBCDs turned out to have important implications about the fundamental conceptual and moral assumptions underlying organ procurement.Although each of the papers in this volume can be read separately, we intend the volume to be read as a whole. Many of the latter pieces on the ethical implications of the policy are best understood in light of the earlier background papers... (shrink)

Organs available for transplantation are scarce and valuable medical resources and decisions about who is to receive them should not be made more difficult by complicated calculations of desert. Consideration of likely clinical outcome must always take priority when allocating such a precious resource otherwise there is a danger of wasting that resource. However, desert may be a relevant concern in decision-making where the clinical risk is identical between two or more potential recipients of organs. Unlikely as this scenario is, (...) such a decision procedure makes clear the interdependence of organ recipient and organ donor and hints at potential disadvantages for those who are willing to accept but unwilling to donate organs (free-riders). A combined opting-out and preference system weakens many of the objections to opting-out systems and may make the decision to donate organs on behalf of their deceased relatives easier for families. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Institute of Medicine’s Report on Non-Heart-Beating Organ TransplantationRoger Herdman (bio), Tom L. Beauchamp (bio), and John T. Potts Jr. (bio)In December 1997, the Institute of Medicine (IOM) released a report on medical and ethical issues in the procurement of non-heart-beating organ donors. This report had been requested in May 1997 by the Department of Health and Human Services (DHHS). We will here describe the genesis (...) of the IOM report, the medical and moral concerns that led the DHHS to sponsor it, the process of producing it, and its conclusions. The analyses, findings, and recommendations of the report are also reviewed, in particular the central issues that led to suggestions for policy changes.Transplantation BackgroundAs a first step, some background in the relevant aspects of organ transplantation will prove useful. For the purposes of this analysis, “transplantation” involves the transfer of cells, tissues, or solid organs from one human to another to replace the structure or function of comparable body components that, through injury or disease, are defective or of inadequate function. The IOM report deals with solid organs, primarily kidneys and livers, whose blood supply is reconnected in the organ recipient, in contrast to cells, like bone marrow, and tissues, like corneas. A variety of donor types exists for organ transplantation, each with particular medical and scientific conditions.Living donors are healthy (and usually genetically related) individuals who volunteer to provide either a whole, paired organ such as a kidney or a section of an organ such as a liver. Cadaver donors are individuals who have died and from whom a full array of organs can be taken. “Heart-beating” cadaver donors are individuals who have suffered “brain death,” that is, irreversible cessation of function of the whole brain including the brain stem; and “non-heart-beating” donors (NHBDs) are individuals who are ill or injured, but not “brain dead,” and who have suffered cardiopulmonary death, that is, irreversible cessation of cardiac and respiratory function. NHBDs can be “controlled,” which means that [End Page 83] they can be sustained by artificial life support systems until a medical and family decision is made to terminate futile life support. This can be done at a scheduled time and in a controlled manner, and organs can then be recovered for transplantation. NHBDs can also be “uncontrolled,” which means that their hearts and breathing have stopped through disease or injury at an unexpected time or in an uncontrolled manner, and they cannot be resuscitated; the organs of some individuals of this description can be recovered for transplantation. The IOM report focused on both controlled and uncontrolled NHBDs and on problems specific to them.The questions that were asked and addressed in the IOM report became current and salient beginning in 1992 with the establishment of the University of Pittsburgh “Policy for the Management of Terminally Ill Patients Who May Become Organ Donors After Death.” This policy addressed controlled NHBDs and the ethical questions raised by their use; much of the discussion was reported in the June 1993 special issue of the Kennedy Institute of Ethics Journal. Public notice and anxiety about some of these concerns were sharpened and refocused by national and local media allegations of improper treatment of donors at the Cleveland Clinic in 1997, specifically premature—i.e., antemortem—recovery of organs and administration of drugs that allegedly might hasten donor death.The DHHS Request for StudyIt is not surprising that several federal actions would be taken in response to these events. Some, such as the results of a transplantation task force, remain largely internal to DHHS at this writing. Others are public, such as the IOM study of the NHBD situation. In May 1997, the DHHS initiated contacts with the IOM with the goal of exploring federal concerns about the medical and ethical treatment of NHBDs, in particular the allegations directed at the Cleveland Clinic.The DHHS response should be understood in at least three contexts. First, living donors and uncontrolled NHBDs were essentially the only donor types in the early days of transplantation in the United States. The technologies, ethics, and social acceptance of controlling and terminating life support for... (shrink)

The imbalance between supply of organs for transplantation and demand for them is widening. Although the current international drive to re-establish procurement via non-heart beating organ donation/donor is founded therefore on necessity, the process may constitute a desirable outcome for patient and family when progression to brain stem death does not occur and conventional organ retrieval from the beating heart donor is thereby prevented. The literature accounts of this practice, however, raise concerns that risk jeopardising professional and (...) public confidence in the broader transplant programme. This article focuses on these clinical, ethical, and legal issues in the context of other approaches aimed at increasing donor numbers. The feasibility of introducing such an initiative will hinge on the ability to reassure patients, families, attendant staff, professional bodies, the wider public, law enforcement agencies, and the media that practitioners are working within explicit guidelines which are both ethically and legally defensible. (shrink)

Background: The family interview context is permeated by numerous ethical issues which may generate conflicts and impact on organ donation process. Objective: This study aims to analyze the family interview process with a focus on principlist bioethics. Method: This exploratory, descriptive study uses a qualitative approach. The speeches were collected using the following prompt: “Talk about the family interview for the donation of organs and tissues for transplantation, from the preparation for the interview to the decision of the family (...) to donate or not.” For the treatment of qualitative data, we chose the method of content analysis and categorical thematic analysis. Participants: The study involved 18 nurses who worked in three municipal organ procurement organizations in São Paulo, Brazil, and who conducted family interviews for organ donation. Ethical considerations: The data were collected after approval of the study by the Research Ethics Committee of the School of Nursing of the University of São Paulo. Results: The results were classified into four categories and three subcategories. The categories are the principles adopted by principlist bioethics. Discussion: The principles of autonomy, beneficence, non-maleficence, and justice permeate the family interview and reveal their importance in the organs and tissues donation process for transplantation. Conclusion: The analysis of family interviews for the donation of organs and tissues for transplantation with a focus on principlist bioethics indicates that the process involves many ethical considerations. The elucidation of these aspects contributes to the discussion, training, and improvement of professionals, whether nurses or not, who work in organ procurement organizations and can improve the curriculum of existing training programs for transplant coordinators who pursue ethics in donation and transplantation as their foundation. (shrink)

There is a widely acknowledged shortage of and an increasing demand for transplantable human organs and tissues (e.g., kidney, heart, lung, liver, cornea) in developed and developing countries around the world. In response to this need, Lott and Savulescu (2007) propose the creation of a human embryonic stem (hESC) bank to facilitate the equitable and efficient dissemination of human leukocyte anti- gen (HLA) matched tissues and organs to patients in need of replacement. Although not an unreasonable proposal, the authors go (...) on to make a much stronger claim. They argue that hESCs are such important tools for addressing the massive unmet global need for organs that it is ethically justified to require mandatory banking of spare embryos, and they argue for the use of financial (or other) inducements to procure embryos for the derivation of hESCs. (shrink)

Organ transplantation is an accepted therapy for major organ failure, but it depends on the availability of viable organs. Most organs transplanted in the U.S. come from either "brain-dead" or living related donors. Recently organ procurement from patients pronounced dead using cardiopulmonary criteria, so-called "non-heart-beating cadaver donors" (NHBCDs), has been reconsidered. In May 1992, the University of Pittsburgh Medical Center (UPMC) enacted a new, complicated policy for procuring organs from NHBCDs after the elective removal of life (...) support. Seventeen months later only one patient has become a NHBCD. This article describes her case and the results of interviews with the health care team and the patient's family. The case and interviews are discussed in relation to several of the ethical concerns previously raised about the policy, including potential conflicts of interest, the definition of cardiopulmonary death, and a possible net decrease in organ donation. The conclusion is reached that organ procurement from non-heart-beating cadavers is feasible and may be desirable both for the patient's family and the health care providers. (shrink)

Recent developments in biotechnology allow for the generation of increasingly complex products out of human tissues, for example, human stem cell lines, synthetic embryo-like structures and organoids. These developments are coupled with growing commercial interests. Although commercialisation can spark the scientific and clinical promises, profit-making out of human tissues is ethically contentious and known to raise public concern. The traditional bioethical frames of gift versus market are inapt to capture the resulting practical and ethical complexities. Therefore, we propose an alternative (...) approach to identify, evaluate and deal with the ethical challenges that are raised by the increasing commercialisation of the exchange of sophisticated human tissue products. We use organoid technology, a cutting-edge stem cell technology that enables the cultivation of ‘mini-organs’ in a dish, as an example. First, we examine the moral value of organoids and recognise them as hybrids that relate to persons and their bodies as well as to technologies and markets in ambiguous ways. Second, we show that commercialisation of organoids is legitimised by a detachment of the instrumental and commercial value of organoids from their associations with persons and their bodies. This detachment is enacted in steps of disentanglement, among which consent and commodification. Third, we contend that far-reaching disentanglement is ethically challenging: (1) Societal interests could be put under pressure, because the rationale for commercialising organoid technology, that is, to stimulate biomedical innovation for the good of society, may not be fulfilled; (2) The interests of donors are made subordinate to those of third parties and the relational moral value of organoids may be insufficiently recognised. Fourth, we propose a ‘consent for governance’ model that contributes to responsible innovation and clinical translation in this exciting field. (shrink)

Non-consensual organ procurement from prisoners in China raises serious questions regarding the ethics of Chinese transplant research. In their article, published in this issue of JME, Higgins and colleagues address these questions through the lens of publication ethics. They argue that, ‘while there are potentially compelling justifications for use [of unethical research] under some circumstances, these justifications fail when unethical practices are ongoing’.1 Consequently, they recommend non-publication of Chinese transplant research and call for a mass retraction of the (...) articles identified in their review.2 To support their argument, Higgins and colleagues appeal to internationally recognised guidelines from the WHO3 and the World Medical Association, which assert that ‘executed prisoners must not be considered as organ and/or tissue donors’ due to the inability to acquire valid consent.4 Failing to declare an immediate publishing moratorium for transplant research involving prisoners in China, they argue, ‘undermines efforts to stop transplant-related human rights abuses, taints the evidence base, and renders those who publish and use the research complicit in the continuing harm’.5 We agree with Higgins and colleagues that non-consensual organ procurement from prisoners in China is a crime against humanity. Ongoing human rights violations in Chinese prisons are well documented and universally condemned. We also agree that the subsequent use of data acquired from unethical research is morally complex. Nonetheless, Higgins and colleagues’ arguments leave us with three …. (shrink)

Procurement of organs from non-heart-beating cadaver donors raises concerns. Standards for optimal patient care during withdrawal of life-sustaining therapy are evolving and continue to be debated and studied. Consensus on specific procedures and methods has not been attained, however, and protocols for the procurement of organs from patients following the withdrawal of life-sustaining therapies may compromise the evolving standards and harm the patient and the attendant family. In addition, there is little evidence to suggest that such protocols will (...) significantly increase the number of organs procured. "Non-heart-beating cadaver" protocols that do not give comprehensive attention to optimal patient/family care at the time of withdrawal of life-sustaining therapy ought not to be endorsed. (shrink)

The movement to try to close the ever-widening gap between demand and supply of organs has recently arrived at the prison gate. While there is enthusiasm for using executed prisoners as sources of organs, there are both practical barriers and moral concerns that make it unlikely that proposals to use prisoners will or should gain traction. Prisoners are generally not healthy enough to be a safe source of organs, execution makes the procurement of viable organs difficult, and organ (...) donation post-execution ties the medical profession too closely to the act of execution. (shrink)

This essay develops a framework for thinking about the moral basis for the commodification of human reproductive materials. It argues that selling and buying gametes and genes is morally acceptable although there should not be a market for zygotes, embryos, or genomes. Also a market in gametes and genes should be regulated in order to address concerns about the adverse social consequences of commodification.

The furore over the retention of organs at postmortem examination, without adequate consent, has led to a reassessment of the justification for, and circumstances surrounding, the retention of any human material after postmortem examinations and operations. This brings into focus the large amount of human material stored in various archives and museums, much of which is not identifiable and was accumulated many years ago, under unknown circumstances. Such anonymous archival material could be disposed of, used for teaching, used for research, (...) or remain in storage. We argue that there are no ethical grounds for disposing of the material, or for storing it in the absence of a teaching or research rationale. Nevertheless, with stringent safeguards, it can be used even in the absence of consent in research and teaching. Regulations are required to control the storage of all such human material, along the lines of regulations governing anatomy body bequests. (shrink)