In lieu of an abstract, here is a brief excerpt of the content:President’s Council on BioethicsEdmund D. Pellegrino (bio) and F. Daniel Davis (bio)Approximately two weeks before what was to have been its final meeting, the White House dissolved the President’s Council on Bioethics by terminating the appointments of its 18 members. The letters of dismissal, dated 10 June 2009, informed the members that their service on the Council would end with the close of business the (...) next day.The Council’s term was set to expire on 30 September 2009. After President Obama’s election in November and during the transition, we were advised to proceed on the assumption that the Council would be permitted to cease on that date. Reasons for the abrupt move to disband the Council are unknown. We have accepted the fact that we Council members served at the pleasure of the President and that he simply exercised his rightful prerogative. No explanation is therefore required.Some observers have speculated that the action was retaliatory. They related to the fact that several members of the Council disagreed with the President’s stem cell policy in a signed statement published in the Hastings Center’s Bioethics Forum. Others have speculated that the move was pre-emptive. At its final meeting, scheduled for 25–26 June, the Council was set to sign-off on two of its final publications. One was a comprehensive report on the ethics of organ transplantation, and the other a white paper entitled Health Care and the Common Good. The aim was immediately to release the latter as a contribution to the intensifying debate about health care reform. Health Care and the Common Good could well have aided rather than impeded the President’s drive to better control health care costs and achieve universal coverage. The Council report attempted to ground both goals in the ethical framework of, as the title indicates, the common good of all Americans.In his letter terminating the members’ appointments, Assistant to the President for Presidential Personnel Don Gips said that the President “recognizes the values of having a commission of experts in bioethical issues to provide objective and non-ideological bioethics advice to his administration.” Gips went on to say that the President is “currently rethinking the purposes and goals of such a bioethics commission, and is carefully considering a revitalized mission and mandate.” And, [End Page 309] responding to media enquiries, White House press officer Reid Cherlin explained that the President’s Council was terminated because it was a “philosophically leaning advisory group” and, according to a New York Times account by Nicholas Wade, “because it favored discussion over developing a shared consensus.” As for the ultimate outcome of the President’s “rethinking,” Cherlin indicated that President Obama will appoint a new commission with the mandate of offering “practical policy options” in bioethics.In the light of our experiences with the Council, we leave it with hopes that certain questions of national importance will be addressed. In light of the nature of federal advisory commissions, what is or are the proper roles of a national bioethics commission? If the aim is to provide advice and counsel to the President or, perhaps to the U. S. Congress, is that advice best rendered as a group consensus or as an in-depth exploration of the inevitably conflicting ethical perspectives on a given issue? How should such a commission be constituted—with what sorts of individuals? And what is the nature of the expertise that they individually and collectively bring to the commission’s functions? If the commission is to promote public debate and discussion, how exactly should it go about that task? And how is the efficacy of a commission to be assessed? Such questions inevitably lead us deep into contested territory, as the experience of this Council has shown: into the intersections of politics, religion, and science and into the relations between practice and theory—between policy and what some seem to deride as “philosophy.” Indeed, policy without an underlying philosophy is an edifice without a foundation; philosophy without policy is a foundation without an edifice.At the last meeting of the Council in March 2009, we launched a discussion of these questions with the... (shrink)

In mid-June 2009, the Obama administration dissolved the President's Council on Bioethics (PCBE), a group established by President George W. Bush in August 2001 and whose nearly eight-year life was marked from beginning to end by controversy. While some will regret the PCBE's passing, others will regard the Council as a failed experiment in doing public bioethics.

In lieu of an abstract, here is a brief excerpt of the content:News from the President’s Council on BioethicsF. Daniel Davis (bio) and Diane M. Gianelli (bio)As most readers of this column already know, the President's Council on Bioethics went through a major transition during the past year when Leon Kass—in October 2005—handed the chairman's gavel over to Georgetown University's Edmund Pellegrino. Dr. Kass has remained on the Council as a member.1When the gavel change took place, (...) the Council's phone started ringing. Everyone wanted to know the same thing: What topics would the Council take up this term? Dr. Pellegrino's answer was always the same: The Council's agenda would be established through a consultative process with the members themselves and with an eye to those problems and controversies in bioethics to which we, as a body, can make a contribution.Taking its cue from the list of potential topics suggested by members, the Council—over the course of the next several meetings—listened to experts on such topics as children and bioethics (with a focus on children in clinical research), organ transplantation, and that oft-cited-but-hard-to-define concept, "human dignity."The latter topic entered the arena of discussion because it is a concept that is cited frequently in the bioethics literature, and it is also one that has figured prominently in Council discussions and documents. Although the concept is widely invoked, there is no universal understanding of what it means, and it is not easy to encapsulate into a one-size-fits-all definition. Indeed, some critics maintain that appeals to human dignity are fig leaves used to camouflage unconvincing arguments. So between December 2005 and April 2006, the Council devoted several sessions to various perspectives on "human dignity: its meaning, its foundations, and its relevance to bioethics." After hearing from James Childress, Patricia Churchland, Daniel Sulmasy, and Paul Weithman2 on the topic, the Council decided to issue a volume of approximately 20 essays, some by Council members and others by scholars from a variety of relevant disciplines.3 The volume is expected to encompass a broad array of opinion on the topic of human dignity and is scheduled to be published next spring."Children" were also the focus of several sessions during the past year. The Council's last report addressed care giving for the elderly.4 After it was issued, several members suggested it was time to focus on the youngest members of [End Page 375] society. The challenge, of course, was to find a topic that was both timely and relevant—and one about which the Council was uniquely qualified to make a contribution. A number of experts in a variety of related fields testified before the Council about possible issues it could explore: newborn screening for genetic disorders; decision-making standards for those who lack capacity; ethical issues in neonatal and pediatric intensive care; pharmacology and psychiatric disorders in children; and children and clinical research. In addition, a number of groups and individuals involved in related topics met with staff to discuss their interests and concerns.This exploratory engagement with facets of the broad topic of children and bioethics led the Council to focus, more narrowly, on a cluster of issues concerning newborn screening for genetic disorders—a topic on which it is likely that the Council will issue a white paper, possibly by next summer. The stimulus for this particular focus has been the American College of Medical Genetics's recommendation that all newborns in the U.S. be screened for a panel of 29 disorders.5 Currently, each state decides for its residents which conditions are subject to mandated screening, so it is possible to get early diagnoses of treatable disorders in one geographical area but not in another. Proponents of screening find the federal approach to mandated screening more equitable. Potential ethical problems, however, exist with the proposal. Some want to ensure that newborns are screened only for treatable conditions on grounds that it would be too burdensome to discover one is carrying the gene for a late-onset disease that cannot be prevented. Others want to make sure that insurance coverage for individuals and their families is... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:News from the President’s Council on BioethicsDiane M. Gianelli (bio) and F. Daniel Davis (bio)Although the President's Council has moved into several new areas of interest during the past year, it also has devoted considerable effort to finalizing several upcoming reports and white papers. In early 2008, the Council will publish a collection of essays on human dignity and bioethics, a report on organ transplantation, (...) and a white paper on "brain death."The Council's report on organ transplantation—now near the end of the drafting and editing phases—has the public as its main audience and, as such, seeks to promote greater understanding of the ethical issues in organ procurement, allocation, and transplantation. The report situates these issues within the contexts of the history of transplantation, the clinical realities of this therapeutic modality, and the current policy framework of state and federal law and regulation.The Council is aware that other bodies—such as the Institute of Medicine—have, in recent years, produced excellent reports on transplantation. The Council's report, however, has a different focus. It explores such foundational issues as the meaning and experience of human embodiment, the philosophy of giving and receiving, and transplantation in relation to the ends and aims of medicine.The report also analyzes the ethics of deceased organ donation, living organ donation, organ allocation, and various proposals for increasing the supply of organs, with a focus on those that call for the replacement of the organ-as-gift philosophy with a market-oriented ethic of selling and buying.In another upcoming publication, the Council revisits the notion of "brain death." The Council did not plan to take on this issue when it began its organ transplantation project. But when researching material for that report, it became clear that—in recent years—some serious criticisms of the neurological standard for declaring death have arisen. Since the vast majority of organs procured from the dead come from "brain dead" patients—that is, those declared dead by the neurological standard—this presented an issue ripe for exploration.The last time a national bioethics body looked at the criteria for determining death was in 1981, when The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research issued "Defining Death," its seminal report that articulated and defended the neurological standard for declaring death. It also proposed a uniform statute for states to adopt based [End Page 397] on that standard. After its publication, states that had not already rewritten their laws to recognize the new neurological standard did so. The Council's white paper on the topic takes a new look at "brain death" in light of the recent evidence and arguments on both sides of the issue.In the Council's last report to the Kennedy Institute of Ethics Journal (December 2006), its upcoming volume on "Dignity" was described. Scholars from a variety of disciplines—and opinions—have written essays on "dignity and bioethics." The volume is ready to go to press.In addition to these documents, the Council, after devoting a number of sessions to the topic over the past couple of years, is considering publication of a white paper on newborn screening, with a probable focus on the benefits, harms, and burdens of mandated screening, and a look at the broader human significance of genetic information. The paper probably also will address the moral precepts that should guide such testing, as well as the precepts that should guide the acquisition and use of the genetic information gained through this process.Venturing into new territory this year, the Council heard from several speakers on "the healing professions" and "the ethical foundations of health care." Both of these topics are the subject of considerable attention and debate in the ethics literature. There is some concern, for example, that medicine and the other healing professions have lost—or are in danger of losing—their moral bearings. And in the controversies surrounding health care reform policies, what is at stake ethically often is obscured, confused, or lacking altogether.Under the rubric of "the professions," the Council heard various dimensions of the issue: the "crisis" in the ethics... (shrink)

The President's Council on Bioethics has recently released a report supportive of the continued use of brain death as a criterion for human death. The Council's conclusions were based on a conception of life that stressed external work as the fundamental marker of organismic life. With respect to human life, it is spontaneous respiration in particular that indicates an ability to interact with the external environment, and so indicates the presence of life. Conversely, irreversible apnoea marks an (...) inability to carry out the necessary work of life, an inability which the Council considers an indicator of death. This conception has been conceived to circumvent criticisms of the previous model of loss of somatic integration, a model the Council admits that, in the presence of evidence of continuing functional integration in brain dead patients, was looking less than convincing. Nevertheless, by focusing on external work and ignoring the more essential work of integrative unity, the Council's conception of the nature of life is untenable, and of no assistance in supporting a relation of equivalence between the concepts of brain death and death. Consequently, the Council's conclusions do little to advance the definition of death debate, a potentially intractable debate that may necessitate the investigation of alternate ethical justifications for organ harvesting. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Incoherence of Determining Death by Neurological Criteria: A Commentary on Controversies in the Determination of Death, A White Paper by the President’s Council on Bioethics*Franklin G. Miller** (bio) and Robert D. Truog (bio)Traditionally the cessation of breathing and heart beat has marked the passage from life to death. Shortly after death was determined, the body became a cold corpse, suitable for burial or cremation. Two technological (...) changes in the second half of the twentieth century prompted calls for a new, or at least expanded, definition of death: the development of intensive care medicine, especially the use of mechanical ventilators, and the advent of successful transplantation of vital organs. Patients with profound neurological damage, leaving them incapable of breathing on their own and in an irreversible coma, could be maintained for some period of time with the aid of mechanical ventilation. The situation of these patients posed two ethical questions. Is it appropriate to stop life-sustaining treatment? If so, is it acceptable to retrieve vital organs for transplantation to save the lives of others before stopping treatment?In 1968, the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death proposed that death could be determined on the basis of neurological criteria, thus providing a positive answer to these two questions (Ad Hoc Committee 1968). According to the position of this committee, patients diagnosed with the cessation of brain function are dead, despite the fact that they breathe and circulate blood with the aid of mechanical ventilation. [End Page 185] Because they are dead, it is appropriate, indeed imperative, to stop mechanical ventilation. And because they are dead, it becomes ethical to procure vital organs for transplantation before stopping what otherwise would be life-sustaining treatment. Remarkably, this innovative neurological determination of death became, with little debate or controversy, the established position in medical ethics and the law throughout the United States.The Harvard Committee articulated the diagnosis of “irreversible coma,” but merely asserted that this condition constituted death. No explanatory rationale was provided. It fell to the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research to provide an authoritative rationale in its 1981 report, Defining Death. The second paragraph of the report set the stage as follows: “The question addressed here is not inherently difficult or complicated. Simply, it is whether the law ought to recognize new means for establishing that the death of a human being has occurred” (President’s Commission 1981, p. 3). The Commission claimed that “death is a unitary phenomenon” (p. 7) and that the determination of death by neurological criteria, in terms of the absence of all brain function, is consistent with the traditional conception of death as the cessation of vital functioning of the organism as a whole. The key issue is the integrative functioning of the human organism, which ceases to exist, according to the Commission, when the whole brain, including higher cortical areas and the brain stem, fails to function. Although “brain-dead” patients do not appear to be dead—i.e., the reality of their death is “masked” by the activity of mechanical ventilation—the patient’s body has irreversibly lost all capacity for integrative functioning. In the words of the Commission: “When artificial means of support mask this loss of integration as measured by the old methods [cessation of respiration and heart beat], brain-oriented criteria and tests provide a new window on the same phenomenon” (p. 33). The President’s Commission was instrumental in developing and establishing “The Uniform Definition of Death Act”: “An individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead” (p. 2).Although the question posed by the President’s Commission was easy to articulate, the answer, over time, has proved complicated and controversial. The coherence and cogency of determining death by neurological criteria has been challenged. Various experts have demonstrated that “brain-dead” patients maintained on mechanical ventilation display a range of vital, integrative, functioning, which conflicts with the judgment that they are dead (Truog and... (shrink)

The issues are familiar to most in bioethics by now, through professional or personal experiences (or both). The rapidly expanding population of elderly persons who require care is raising critical...

The report of the President's Council on Bioethics, Human Cloning and Human Dignity, addresses the central ethical, political, and policy issue in human embryonic stem cell research: the moral status of extracorporeal human embryos. The Council members were in sharp disagreement on this issue and essentially failed to adequately engage and respectfully acknowledge each others' deepest moral concerns, despite their stated commitment to do so. This essay provides a detailed critique of the two extreme views on the (...) Council (i.e., embryos have full moral status or they have none at all) and then gives theoretical grounding for our judgment about the intermediate moral status of embryos. It also supplies an account of how to address profound moral disagreements in the public arena, especially by way of constructing a middle ground that deliberately pays sincere respect to the views of those with whom it has deep disagreements. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Incoherence of Determining Death by Neurological Criteria: A Commentary on Controversies in the Determination of Death, A White Paper by the President’s Council on Bioethics*Franklin G. Miller** (bio) and Robert D. Truog (bio)Traditionally the cessation of breathing and heart beat has marked the passage from life to death. Shortly after death was determined, the body became a cold corpse, suitable for burial or cremation. Two technological (...) changes in the second half of the twentieth century prompted calls for a new, or at least expanded, definition of death: the development of intensive care medicine, especially the use of mechanical ventilators, and the advent of successful transplantation of vital organs. Patients with profound neurological damage, leaving them incapable of breathing on their own and in an irreversible coma, could be maintained for some period of time with the aid of mechanical ventilation. The situation of these patients posed two ethical questions. Is it appropriate to stop life-sustaining treatment? If so, is it acceptable to retrieve vital organs for transplantation to save the lives of others before stopping treatment?In 1968, the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death proposed that death could be determined on the basis of neurological criteria, thus providing a positive answer to these two questions (Ad Hoc Committee 1968). According to the position of this committee, patients diagnosed with the cessation of brain function are dead, despite the fact that they breathe and circulate blood with the aid of mechanical ventilation. [End Page 185] Because they are dead, it is appropriate, indeed imperative, to stop mechanical ventilation. And because they are dead, it becomes ethical to procure vital organs for transplantation before stopping what otherwise would be life-sustaining treatment. Remarkably, this innovative neurological determination of death became, with little debate or controversy, the established position in medical ethics and the law throughout the United States.The Harvard Committee articulated the diagnosis of “irreversible coma,” but merely asserted that this condition constituted death. No explanatory rationale was provided. It fell to the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research to provide an authoritative rationale in its 1981 report, Defining Death. The second paragraph of the report set the stage as follows: “The question addressed here is not inherently difficult or complicated. Simply, it is whether the law ought to recognize new means for establishing that the death of a human being has occurred” (President’s Commission 1981, p. 3). The Commission claimed that “death is a unitary phenomenon” (p. 7) and that the determination of death by neurological criteria, in terms of the absence of all brain function, is consistent with the traditional conception of death as the cessation of vital functioning of the organism as a whole. The key issue is the integrative functioning of the human organism, which ceases to exist, according to the Commission, when the whole brain, including higher cortical areas and the brain stem, fails to function. Although “brain-dead” patients do not appear to be dead—i.e., the reality of their death is “masked” by the activity of mechanical ventilation—the patient’s body has irreversibly lost all capacity for integrative functioning. In the words of the Commission: “When artificial means of support mask this loss of integration as measured by the old methods [cessation of respiration and heart beat], brain-oriented criteria and tests provide a new window on the same phenomenon” (p. 33). The President’s Commission was instrumental in developing and establishing “The Uniform Definition of Death Act”: “An individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead” (p. 2).Although the question posed by the President’s Commission was easy to articulate, the answer, over time, has proved complicated and controversial. The coherence and cogency of determining death by neurological criteria has been challenged. Various experts have demonstrated that “brain-dead” patients maintained on mechanical ventilation display a range of vital, integrative, functioning, which conflicts with the judgment that they are dead (Truog and... (shrink)

(2005). Reflections on the Appointment of Dr. Edmund Pellegrino to the President's Council on Bioethics. The American Journal of Bioethics: Vol. 5, No. 6, pp. W8-W9. doi: 10.1080/15265160500388640.

Contains a collection of essays exploring human dignity and bioethics, a concept crucial to today's discourse in law and ethics in general and in bioethics in particular.

McGovern, Kevin In December 2008, the US President's Council on Bioethics issued a White Paper titled 'Controversies in the Determination of Death.'1 Responding to contemporary critiques of the concept of brain death, the Council upholds the validity of this neurological standard for determining death. Significantly, it also proposes replacing the existing explanation of this standard with a new, very different rationale. As well, it argues that 'total brain failure' is a better name for this condition than 'brain (...) death.' This article summarises and then comments on this important statement. (shrink)

: The President's Council on Bioethics has tried to make a distinctive contribution to the methodology of such public bodies in developing what it has styled a "richer bioethics." The Council's procedure contrasts with more modest methods of public bioethical deliberation employed by the United Kingdom's Warnock Committee. The practices of both bodies are held up against a backdrop of concerns about moral and political alienation, prompted by the limitations of moral reasoning and by moral dissent (...) from state policy under even the most democratic of governments. Although the President's Council's rhetoric is often scrupulously conciliatory, recurring features of its argumentative practice are regrettably divisive. They order these things better in Britain. (shrink)

The President’s Council on Bioethics has addressed the moral status of human preembryos in its reports on stem cell research and human therapeutic cloning. Although the Council has been criticized for being hand-picked to favor the right-to-life viewpoint concerning human preembryos, it has embraced the idea that the right-to-life position should be defended in secular terms. This is an important feature of the Council’s work, and it demonstrates a recognition of the need for genuine engagement between (...) opposing sides in the debate over stem cell research. To promote this engagement, the Council has stated in secular terms several arguments for the personhood of human preembryos. This essay presents and critiques those arguments, and it concludes that they are unsuccessful. If the best arguments in support of the personhood of human preembryos have been presented by the Council, then there are no reasonable secular arguments in support of that view. (shrink)

This paper argues the distinctiveness of the President’s Council on Bioethics, as chaired by Leon Kass. The argument proceeds by seeking to place the Council in proper historical and philosophical perspective and considering the implications of some of its work. Sections one and two provide simplified descriptions of the historical background against which the Council emerged and the character of the Council itself, respectively. Section three then considers three basic issues raised by the work of (...) the Council that are of relevance to philosophy and technology as a whole: the role of professionalism, the relation between piecemeal and holistic analyses of technology, and the appeal to human nature as a norm. (shrink)

This paper argues the distinctiveness of the President’s Council on Bioethics, as chaired by Leon Kass. The argument proceeds by seeking to place the Council in proper historical and philosophical perspective and considering the implications of some of its work. Sections one and two provide simplified descriptions of the historical background against which the Council emerged and the character of the Council itself, respectively. Section three then considers three basic issues raised by the work of (...) the Council that are of relevance to philosophy and technology as a whole: the role of professionalism, the relation between piecemeal and holistic analyses of technology, and the appeal to human nature as a norm. (shrink)

Nonhuman primates represent an important reservoir for the transmission of new infectious diseases to humans. While several working groups and international agencies have grappled with the ethics of xenotransplantation, the Nuffield Council on Bioethics have recently published a comprehensive and far-reaching series of recommendations that, while not eliminating the infectious disease risks, have nonetheless detailed the major points for concern and have developed a rational approach to minimizing these risks. This report should serve as the blueprint from which (...) to proceed with xenotransplantation. (shrink)

Several presidents have created bioethics councils to advise their administrations on the importance, meaning and possible implementation or regulation of rapidly developing biomedical technologies. From 2001 to 2005, the President's Council on Bioethics, created by President George W. Bush, was under the leadership of Leon Kass. The Kass Council, as it was known, undertook what Adam Briggle describes as a more rich understanding of its task than that of previous councils. The council sought to understand (...) what it means to advance human flourishing at the intersection of philosophy, politics, science, and technology within a democratic society. Briggle's survey of the history of U.S. public bioethics and advisory bioethics commissions, followed by an analysis of what constitutes a "rich" bioethics, forms the first part of the book. The second part treats the Kass Council as a case study of a federal institution that offered public, ethical advice within a highly polarized context, with the attendant charges of inappropriate politicization and policy irrelevance. The conclusion synthesizes the author's findings into a story about the possible relationships between philosophy and policy making. "Adam Briggle has written a rich and sympathetic account of the President's Council on Bioethics led by Leon Kass. It puts in historical context the efforts of this council to move beyond the limited 'instrumentalist' approaches to bioethics taken by earlier commissions, toward a more philosophically serious effort to deliberate on the human goods put in play by modern biomedicine. In the process it answers many of the charges of politicization and corrects the record concerning the council's work." --_Francis Fukuyama, The Johns Hopkins School of Advanced International Studies_ "What an eloquent, humane, and wise book. Briggle discovers an imperfect yet fascinating effort to bring the world of biomedical research into the domain of public philosophy. His scholarship and generosity make clear that a democratic society need not be morally shackled to the realm of the possible that science is constantly expanding." --_Daniel Sarewitz, Consortium for Science, Policy, and Outcomes, Arizona State University _ "This is the most persuasive and thoughtful reconstruction of the Kass Council's goals and rationale that I have seen. Adam Briggle's account of the notion of a 'richer' bioethics is comprehensive an well-reasoned." --_Jonathan D. Moreno, University of Pennsylvania _ "Adam Briggle has written a fine book on a complex, controversial topic. He shows the wisdom of the approach to bioethics taken by the Kass Council, sets right the unfair and often nasty attacks on the council and Kass himself, and offers a perceptive and wide-ranging look at the terrain of ethics." --_Daniel Callahan, The Hastings Center _. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 97-114 [Access article in PDF] Stem Cell Research in the U.S. after the President's Speech of August 2001 Cynthia B. Cohen On 9 August 2001, in a nationally televised speech, President Bush addressed the contentious question of whether to provide federal funds for human embryonic stem cell research (White House 2001).1 This research involves taking the primordial cells found in embryos and (...) transforming them into certain specialized cells, such as those of the heart, nerves, and muscles, with the ultimate goal of transferring these cells into patients to repair damaged cells and tissues. In his remarks, the President authorized funding for research only on stem cells already harvested from remaining embryos at in vitro fertilization (IVF) centers as of 9 August 2001, the date of the speech. In a "Fact Sheet" about embryonic stem cell research, he added the ethical requirements that (1) the donors of embryos gave informed consent to the derivation of stem cells from their embryos, (2) the embryos were created solely for reproductive purposes, and (3) no financial inducements were given to the embryo donors. The President also prohibited federally funded research on embryonic stem cells derived from embryos after 9 August 2001, as well as the creation of embryos for research purposes and the cloning of human embryos for both reproductive and research purposes. He did not seek to ban the pursuit of embryonic stem cell research with private funds. "This allows us to explore the promise and potential of stem-cell research without crossing a fundamental moral line by providing taxpayer funding that would sanction or encourage further destruction of embryos," the President stated (White House 2001).The President's speech stirred intense controversy. Many applauded the new policy because it allowed some embryonic stem cell research to proceed, thereby raising hope that treatments might be developed for those suffering from such conditions as Parkinson's disease, Alzheimer's disease, and diabetes. Others supported it on grounds that it would discourage the future destruction of embryos in stem cell research. They maintained that although it was wrong to have derived stem cells from embryos, this wrong was no longer remediable and it therefore was justifiable to allow research using such embryos to proceed. Some, however, objected to the new policy because they held that it unduly limited the [End Page 97] number of embryonic stem cells available for federally funded research. Still others opposed it on grounds that it made the federal government complicit in what they took to be the wrongful destruction of human embryos that had taken place prior to 9 August 2001. The President established the President's Council on Bioethics by executive order in November 2001 and charged it, among other tasks, with monitoring stem cell research and recommending guidelines and regulations for biomedical innovations.Questions about the moral status of human embryos have so captured public attention since the President issued his remarks that other significant ethical and policy issues raised about stem cell research inside the Beltway have remained in the shadows. A number of individuals and organizations—legislators, scientists, patient groups, the President's Council on Bioethics, ethicists, religious task forces, and social commentators—have attempted to bring these other issues to legislative and public attention. They also have revisited the more publicly prominent question of what sorts of protections we owe to human embryos. In response, Congress has attempted to address several of these newly emerging issues at hearings and in legislation. I review these efforts, consider developing issues and arguments, and conclude by exploring possible future directions for federal and private sector stem cell policy. The Availability of Embryonic Stem Cell Lines to Federally Funded Researchers President Bush, in developing his stem cell research policy, accepted a distinction between the "derivation" and the "use" of embryos enunciated by the General Counsel of the Department of Health and Human Services toward the end of the Clinton administration. This distinction was adopted to avoid contravening the Dickey-Wicker Amendment (added... (shrink)

The following article analyzes the process of conception, elaboration, and adoption of the Universal Declaration of Bioethics and Human Rights, and reflects on the lessons it might hold for public bioethics on the international level. The author was involved in the process at a variety of levels: he provided advice to the IBC on behalf of the President's Council of Bioethics; he served as the U.S. representative to UNESCO's Intergovernmental Bioethics Committee; and led the U.S. (...) Delegation in the multilateral negotiation of Government experts that culminated in the adoption of the declaration in its final form. The author is currently serving a 4-year term as a member of UNESCO's International Bioethics Committee. (shrink)

Mitochondrial replacement techniques, known in the popular media as 'three-parent' or 'three-person' IVFs, have the potential to enable women with mitochondrial diseases to have children who are genetically related to them but without such diseases. In the debate regarding whether MRTs should be made available, an issue that has garnered considerable attention is whether MRTs affect the characteristics of an existing individual or whether they result in the creation of a new individual, given that MRTs involve the genetic manipulation of (...) the germline. In other words, do MRTs affect the qualitative identity or the numerical identity of the resulting child? For instance, a group of panelists on behalf of the UK Human Fertilisation and Embryology Authority has claimed that MRTs affect only the qualitative identity of the resulting child, while the Working Group of the Nuffield Council on Bioethics has argued that MRTs would create a numerically distinct individual. In this article, I shall argue that MRTs do create a new and numerically distinct individual. Since my explanation is different from the NCOB's explanation, I shall also offer reasons why my explanation is preferable to the NCOB's explanation. (shrink)

One objection to enhancement technologies is that they might lead us to live inauthentic lives. Memory modification technologies (MMTs) raise this worry in a particularly acute manner. In this paper I describe four scenarios where the use of MMTs might be said to lead to an inauthentic life. I then undertake to justify that judgment. I review the main existing accounts of authenticity, and present my own version of what I call a “true self” account (intended as a complement, rather (...) than a substitute, to existing accounts). I briefly describe current and prospective MMTs, distinguishing between memory enhancement and memory editing . Moving then to an assessment of the initial scenarios in the light of the accounts previously described, I argue that memory enhancement does not, by its very nature, raise serious concerns about authenticity. The main threat to authenticity posed by MMTs comes, I suggest, from memory editing. Rejecting as inadequate the worries about identity raised by the President’s Council on Bioethics in Beyond Therapy , I argue instead that memory editing can cause us to live an inauthentic life in two main ways: first, by threatening its truthfulness, and secondly, by interfering with our disposition to respond in certain ways to some past events, when we have reasons to respond in such ways. This consideration allows us to justify the charge of inauthenticity in cases where existing accounts fail. It also gives us a significant moral reason not to use MMTs in ways that would lead to such an outcome. (shrink)

: For many reasons, and more than its predecessors, the President's Council on Bioethics has been the subject of much public attention and heated controversy. But little of that attention and controversy has been informed by knowledge of the Council's mission, its ways of working, and, most importantly, its actual work. This essay describes the Council's mission, discusses its public ways of working, and reviews the five major works produced during the Council's first term. In (...) all its activities, the Council has sought to develop a richer bioethics, one that recognizes and tries to do justice to the deep issues of our humanity raised by the age of biotechnology. Believing that these issues are properly matters to be discussed and governed by the polity as a whole, the Council also has sought to contribute to a genuinely public or political bioethics, beyond the rule of "experts," scientific and bioethical. (shrink)

Ever so often in the UK, there is a flurry of activity around the information requirements of donor-conceived individuals. In April 2013, it was the launch of a report from the Nuffield Council on Bioethics that brought the issue back to public consciousness.1Since 1991, information about treatment with donor gametes or embryos has been collected by the Human Fertilisation and Embryology Authority. Since then, over 35 000 donor-conceived individuals have been born through treatment in licensed clinics. Medical information (...) and information about donors’ appearance are collected by clinics, and donors are encouraged to put together a ‘pen portrait’ giving information about themselves for any resulting children. One focus of the new report is on improving the quality and quantity of information available about donors.Traditionally, gamete and embryo donations were practised on an anonymous basis, so that those born as a result of such donation may receive only non-identifying information about the donor when they reach the age of 18. This changed in 2005 when donor anonymity was removed so that anyone donating after that time could be identified to individuals born as a result of the treatment. Those who have donated in the past are also able to reregister as identifiable donors. Much concern was expressed at the time that this would exacerbate the shortage of donors although the Nuffield Council on Bioethics reports that, 8 years on, those clinics that actively recruit donors appear to be successful in finding sufficient donors. The report recommends that the option of anonymous donation should not be reintroduced.A big issue of debate in the UK has been, and continues to be, whether parents should tell their …. (shrink)

Anti-aging medicine has emerged in the past two decades as both a medical practice and scientific objective largely aimed at intervening into the process of aging itself rather than its “associated” diseases. This has provoked a both excitement and concern in bioethical deliberations on the meaning and potential impact of an effective intervention. In this article, I examine the different ways in which bioethicists, other social scientists, and anti-aging proponents frame anti-aging goals, in particular, the construction of immortality as its (...) implicit and explicit aim. This research is based upon over 9 years of anthropological, ethnographic interview- and observation-based research in the field and draws substantially from the US President’s Council on Bioethics’ deliberations on this topic as well as from interview data and other publications/discussion on anti-aging medicine. I argue that while the framework of life and death provide the primary structure for many bioethical and social science critiques of anti-aging medicine, many if not most anti-aging practitioners, researchers, and advocates employ the alternative structure of health and pain to orient their work. These divergent orientations of life/death and health/pain beget competing conversations around anti-aging medicine; including voices from the front lines of anti-aging practice complicate bioethical critiques and ultimately beg different questions. Positioning the painful, physiological decline of aging as the ultimate adversary rather than death challenges traditional models of biomedical intervention based on “nature” and “disease” constructions. (shrink)

ABSTRACT The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and some less so. (...) For example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk requirement and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer pragmatic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommendations, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki. (shrink)

This article focuses on two possible missions for a national bioethics commission. The first is handling differences of worldview, political orientation, and discipline. Recent work in political philosophy emphasizes regard for the dignity of difference manifested in "conversation" that seeks understanding rather than agreement. The President's Council on Bioethics gets a mixed review in this area. The second is experimenting with prophetic bioethics. "Prophetic bioethics" is a term coined by Daniel Callahan to describe an alternative (...) to compromise-seeking "regulatory bioethics." It involves a critique of modern medicine. In the contemporary context, the areas of biotechnology and access to health care cry out for prophetic attention. The Council has addressed biotechnology; unfortunately, that experience suggests that the kind of prophecy that it practices poses risks to conversation. With regard to access issues, the article proposes an effort that unites themes of human dignity, solidarity, and limits in support of reform, while highlighting, rather than papering over, differences. (shrink)

This book assesses how Vatican II opened up the Catholic Church to encounter, dialogue, and engagement with other world religions. Opening with a contribution from the President of the Pontifical Council for Interreligious Dialogue, Cardinal Jean-Louis Tauran, it next explores the impact, relevance, and promise of the Declaration Nostra Aetate before turning to consider how Vatican II in general has influenced interfaith dialogue and the intellectual and comparative study of world religions in the postconciliar decades, as well as the (...) contribution of particular past and present thinkers to the formation of current interreligious and comparative theological methods. Additionally, chapters consider interreligious dialogue vis-à-vis theological anthropology in conciliar documents; openness to the spiritual practices of other faith traditions as a way of encouraging positive interreligious encounter; the role of lay and new ecclesial movements in interreligious dialogue; and the development of Monastic Interreligious Dialogue. Finally, it includes a range of perspectives on the fruits and future of Vatican’s II’s opening to particular faiths such as Judaism, Islam, Hinduism, and Buddhism. (shrink)

A multitude of legislation impacts the use of samples and data for research in South Africa. With the coming into effect of the Protection of Personal Information Act No. 4 of 2013 in July 2021, recent attention has been given to safeguarding research participants’ personal information. The protection of participants’ privacy in research is essential, but it is not the only risk at stake in the use and sharing of personal information. Other rights and interests that must also be considered (...) and safeguarded include the right to non-discrimination, the right to dignity, and the right to enjoy the benefits of scientific progress. This can be achieved by ensuring that the ethical values and universal principles that underpin the research landscape, namely equity, reciprocity, justice and solidarity, are embedded in the regulatory framework for the management and use of personal information. This paper advocates an integrated bioethics approach to the use of personal information for research in SA. A key feature in embedding such an approach is a Data Transfer Agreement that appropriately integrates the safeguards and protections set out by our regulatory framework with bioethical rules and procedures when personal information is used and shared for research purposes. This paper thus calls for the development of a national DTA that is guided by key ethical principles when data are shared for research purposes. This paper will be followed by a webinar on 23 June 2022 hosted by the Department of Science and Innovation and the SA Medical Research Council, where the recommendations and suggestions set out herein will be unpacked, discussed and debated by relevant stakeholders. (shrink)