: In 1998, researchers discovered that embryonic stem cells could be derived from early human embryos. This discovery has raised a series of ethical and public-policy questions that are now being confronted by multiple international organizations, nations, cultures, and religious traditions. This essay surveys policies for human embryonic stem cell research in four regions of the world, reports on the recent debate at the United Nations about one type of such research, and reviews the positions that various religious traditions have (...) adopted regarding this novel type of research. In several instances the religious traditions seem to have influenced the public-policy debates. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 171-174 [Access article in PDF] Bioethics Inside the Beltway The Oversight of Human Gene Transfer Research LeRoy Walters Jesse Gelsinger's death last September in a gene transfer study being conducted at the University of Pennsylvania has helped to spark a national debate. In part, this debate parallels the broader discussion of how human subjects research should be reviewed and regulated (...) in the United States. However, human gene transfer research is one of a handful of biomedical technologies that seem to deserve special attention, at least in the early years of their development.The major participants in the national debate on human gene transfer include the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Bioethics Advisory Commission, members of Congress, biotechnology and pharmaceutical companies, disease-oriented advocacy groups, reporters, and academics. At the December 1999 meeting of the NIH Recombinant DNA Advisory Committee (RAC), the protocol that involved Jesse Gelsinger was a central focus of discussion, but other topics emerged as well. One ad hoc panel reviewed adverse events that had occurred in other research protocols using adenovirus vectors, while a second proposed changes in the general system for reporting adverse events to NIH and the RAC.During the first several months of the year 2000, the United States Congress also became involved in the human gene transfer debate. In February, Senator Bill Frist (R-TN) convened a hearing to which Jesse Gelsinger's father, representatives of NIH and FDA, and several other witnesses were invited. At approximately the same time, the House Commerce Committee and its Subcommittee on Oversight and Investigations initiated their own inquiries, asking the Office of Inspector General at the Department of Health and Human Services to review the oversight roles of NIH and FDA. In March and April, the House committee also wrote directly to the NIH Director, the FDA Commissioner, and the President of the University of Pennsylvania, requesting extensive documentation on gene transfer, in general, and the trial in which Jesse Gelsinger was involved, in particular. Congressman Henry Waxman (D-CA) and Senator Edward Kennedy (D-MA) have also raised questions and proposed solutions in multiple letters to the NIH Director and the Secretary of Health and Human Services. [End Page 171]The major general questions that have emerged from this discussion are the following:(1) What kinds of information about adverse events should be reported by researchers or sponsors during the course of human gene transfer trials?(2) To what group or groups should adverse-event information be reported? How often and in what ways should the information be analyzed?(3) Should the information about adverse events remain confidential, or should it be discussed publicly?(4) How can the disclosure and consent process in gene transfer trials be improved?(5) Which federal agency should have primary responsibility for overseeing human gene transfer research, and how can it best fulfill its oversight role?How these questions are answered will have immediate relevance to the field of human gene transfer research as it enters into its next phase. At the same time, the models that are created for this important cutting-edge field also may be useful in other complex or controversial arenas of biomedical research, for example, xenotransplantation or human embryonic stem-cell research. In addition, the lessons learned from this one important area of human subjects research may suggest ways to improve protections for all the volunteers who make clinical research--and medical progress--possible.In the remainder of this article, I will turn from reporting, in as objective a way as possible, on the status of the public policy debate about human gene transfer research to suggesting measures for improving the current oversight system for such research. My initial general recommendation is that we should not expect a single regulatory agency to be solely responsible for a field as large and dynamic as human gene transfer research. Rather, there should be some helpful redundancy or, to change the metaphor, checks and balances in the public oversight of this field. Thus, an... (shrink)

In 1969, the field of human genetics was in its infancy. Amniocentesis was a new technique for prenatal diagnosis, and a newborn genetic screening program had been established in one state. There were also concerns about the potential hazards of genetic engineering. A research group at the Hastings Center and Paul Ramsey pioneered in the discussion of genetics and bioethics. Two principal techniques have emerged as being of enduring importance: human gene transfer research and genetic testing and screening. This essay (...) tracks the development and use of these techniques and considers the ethical issues that they raise. (shrink)

The last quarter of the twentieth century has given rise to reproductive technologies and arrangements that in the earlier part of the century could only be dreamed of by the authors of science fiction. We stand in the middle of this reproductive revolution, trying to cope with the developments that have already occurred but with an uneasy sense that the future may be even more complicated ethically than the past and the present. In this brief essay, I will survey recent (...) ethical and public-policy discussions of two reproductive techniques (assisted insemination and in vitro fertilization) and one reproductive arrangement (surrogate motherhood). After distinguishing three phases in the normative debate, I will briefly comment on some of the characteristics of, and continuing ambiguities in, the ethical debate of the past 25 years. At the conclusion of the essay, I will attempt to anticipate three future issues in ethics and reproduction. (shrink)

This essay explores some moral problems raised by experimentation involving the human fetus. In the first part of the essay three examples of fetal experimentation from the medical literature are described in some detail. Next, the ethical and legal arguments employed in the two major existing public policy-documents on fetal experimentation are analyzed. Finally, the author seeks to identify four fundamental presuppositions which underlie divergent normative positions on the problem of fetal experimentation.

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.3 (2004) vii-viii [Access article in PDF] John C. Fletcher 1931-2004 John Fletcher was one of the pioneers in the still-young field of bioethics. In this short tribute, I can only hope to highlight a few of the many contributions he made to the field.For many of us, our first introduction to John occurred in October 1971. At an international symposium sponsored by the (...) Kennedy Foundation, the film "Who Should Survive?" depicted the dramatic case of an infant with Down syndrome and an intestinal blockage. The parents of the infant refused surgery to relieve the obstruction, and the healthcare providers for the infant decided not to pursue a court order permitting the surgery. During a period of approximately two weeks the infant was allowed to die.In the second part of "Who Should Survive?" John was one of several panelists invited to discuss the decisions made in this case. After acknowledging how troubling the infant's death was to him, John nonetheless sought to be empathic with the parents. He pointed out that in the re-enactment of the case the faces of the parents were never seen, and he worried that the film did not permit the parents to discuss the reasons for the choice they had made. John realized that his position would not be shared by most other panelists. Yet he had the courage to take an unpopular stand and to challenge other panelists—and the audience—not to reach premature closure on complex ethical dilemmas.Already in 1967, John had begun contributing to the literature of bioethics. His essay "Human Experimentation: Ethics in the Consent Situation," appeared in Law and Contemporary Problems. At the time, John was deeply immersed in studying the ethical dimensions of research with human subjects at the NIH Clinical Center. Paul Ramsey cited John's work with appreciation in his 1970 book, The Patient as Person. By the time he completed his dissertation at Union Theological Seminary in 1969, John was arguably one of the best trained bioethicists in the world—before there was a field of bioethics.After serving as chaplain, teaching at Virginia Theological Seminary, and founding and leading a seminary without walls in Washington, DC, John became the chief of the ethics program at the NIH Clinical Center in 1977. There he had the unenviable task of providing a second review for all clinical protocols emerging from the intramural programs of the NIH institutes. John discovered that in some cases the institutional review boards of the institutes had overlooked important ethical questions. This role also [End Page vii] required courage. At times John found it necessary to challenge senior NIH researchers, even institute directors, and to request protocol revisions that in his view were required for the protection of human subjects.In 1980, after Martin Cline had performed an unauthorized gene transfer experiment involving thalassemia patients, John joined with physician W. French Anderson to write an essay entitled "Gene Therapy in Human Beings: When Is It Ethical to Begin?" [New England Journal of Medicine 303: 1293-97]. Not only did this essay help to defuse a potentially explosive problem for NIH, which had funded Cline's research. It also provided a set of guidelines for the conduct of human gene transfer research that is of continuing relevance today.At times John disagreed with federal policies on research, for example, conservative policies on human embryo research. He also chafed at the idea of subjecting his publications to prior NIH review, both for accuracy and for political correctness. Thus, he welcomed the opportunity to move to the University of Virginia in 1987. There his academic career flowered, and he enjoyed some of his most productive years of research and writing.Among his many contributions during these later years, John participated as Committee co-chair in an effort to "redress the wrongs of Tuskegee." The Tuskegee Syphilis Study Legacy Committee proposed in May 1996 that President Clinton apologize to the participants in the Tuskegee study on behalf of the federal government. In May 1997, the President did in... (shrink)

According to a prevalent and rather influential typology, the just war and the crusade are antitheses in four respects. The requisite authority for a just war is the prince or the state; the crusade, on the other hand, is fought “under the auspices of the Church or of some inspired religious leader.” Second, the cause or aim of the just war is to protect society from offenses against life and property; in contrast, the object of the crusade is to promote (...) a religious or quasi-religious ideal. Third, the attitude of just warriors is one of reluctant resignation to performing an unpleasant but necessary task; crusaders, however, welcome the opportunity to wreak vengeance on the enemy. Finally, whereas the just war is characterized by moderation in the use of military. means, the crusade almost inevitably leads to indiscriminate violence. (shrink)

If stem cell-based therapies are developed, we will likely confront a difficult problem of justice: for biological reasons alone, the new therapies might benefit only a limited range of patients. In fact, they might benefit primarily white Americans, thereby exacerbating long-standing differences in health and health care.

Book reviewed in this article: Ethical Issues in Social Research. Edited by Tom L. Beauchamp, Ruth R. Faden, R. Jay Wallace, Jr., and LeRoy Walters. Baltimore: The Johns Hopkins University Press, 1982. xii + 436 pp. $25.00 (hardcover); $8.95 (paper). Ethics of Human Subject Research. Edited by Allan J. Kimmel, Jr. San Francisco: Jossey‐Bass, 1981. 106 pp. $6.95 (paper). Social Research Ethics. Edited by Martin Bulmer. New York: Holmes & Meier, 1982. xiv + 284 pp. $39.50 (hardcover); $14.50 (...) (paper). The Ethics of Social Research: Field‐work, Regulation and Publication. Edited by Joan E. Sieber. New York: Springer‐Verlag, 1982. x + 187 pp. $23.50 (hardcover). The Ethics of Social Research: Surveys and Experiments. Edited by Joan E. Sieber. New York: Springer‐Verlag, 1982. xii + 249 pp. $23.50 (hardcover). (shrink)

The June 1975 issue of the Hastings Center Report published the Deliberations and Recommendations of the National Commission for the Protection of Human Subjects concerning the regulation of fetal experimentation. The Commission's most controversial conclusions were as follows: First, it voted to allow non‐therapeutic research on the human fetus, provided important biomedical knowledge could not be gained in any other way, proper consent had been obtained, and the research imposed “minimal or no risk to the well‐being of the fetus” (Recommendation (...) 4). Because interpretations of the last phrase varied in the case of fetuses scheduled for abortion, the Commission recommended that a national ethical review body be able to rule on disputed cases (Recommendation 5). In the case of research during abortion and research on the non‐viable fetus ex utero, the Commission's interpretation of permissible “harm” was restricted to the proviso that “no intrusion into the fetus [may be] made which alters the duration of life” (Recommendation 6). The Commission also recommended further research on abortion techniques (Recommendation 12). The Secretary of Health, Education and Welfare accepted the Commission's Recommendations almost without change—the major modification was to request paternal consent rather than to rely on the fact that “the father has not objected.” The DHEW regulations were published in the Federal Register on Friday, August 8, 1975, and written comments on them were invited. Already, however, a number of commentators including several members of the Commission had offered either dissenting or qualifying remarks. Some are printed here. (shrink)

Many philosophers of religion are unaware of research done on comparative religions, and continue to use language and to address issues that distort the nature of human religious endeavor. Despite work by Cantwell Smith, Ludwig Wittgenstein, Wittgensteinians, and their critics, these scholars continue to confuse faith with (propositional) belief, and miss the significance of the dynamic nature of religious culture in historic context. In this paper, I defend Walter Kaufmann's view that religion addresses an essential human ontological need, on the (...) grounds that it makes sense of the immense diversity of religious expression and endeavor. (shrink)

Many philosophers of religion are unaware of research done on comparative religions, and continue to use language and to address issues that distort the nature of human religious endeavor. Despite work by Cantwell Smith, Ludwig Wittgenstein, Wittgensteinians, and their critics, these scholars continue to confuse faith with (propositional) belief, and miss the significance of the dynamic nature of religious culture in historic context. In this paper, I defend Walter Kaufmann's view that religion addresses an essential human ontological need, on the (...) grounds that it makes sense of the immense diversity of religious expression and endeavor. (shrink)

LeRoy Walters was a central figure in debates about federal policy regarding genetics and biotechnology—a neutral, publicly engaged philosopher and religious studies academic who put his skills to work in national service. His career spanned the emergence of biotechnology as a field in the 1970s until his retirement. His interests reached from moral philosophical theory to Holocaust studies to practical concerns about public policy in genetics. We focus here on the role of bioethics in policy related to the (...) advent of human gene transfer, the Human Genome Project, and the emergence of biotechnology as a commercial enterprise. We focus on his role as an academic influencing the government strand of the “triple helix”... (shrink)

Since the birth of bioethics, a persistent refrain has been that advances in science, technology, and health are occurring so quickly that they threaten to outpace society’s ability to understand and react to them. Genomics, big data, and synthetic biology preoccupy current scholarly and policy debates, just as organ transplantation, in vitro fertilization, human subjects research, and gene therapy did over the past forty years. But the history of bioethics is more than the topics it has addressed. It is also (...) the story of the people whose voices shaped its debates and built society’s capacity to manage the escalating pace of technological change.LeRoy Walters is one of those contributors who made a difference. He... (shrink)

Aboriginal peoples are forever explaining themselves to non-Aboriginal people: telling their stories, explaining their beliefs and ceremonies, and introducing ideas that have never crossed the non-Aboriginal mind. Western knowledge operates from a linear, singular view; it views the world from order beneath chaos; it is very noun oriented; knowledge is about oneself in relation to everything else in a relativistic sense. Aboriginal knowledge has a very different “coming to know.” It is holistic and cyclical; it views the world from chaos (...) underneath order; its languages are process and action oriented. Knowledge is about participation in and with the natural world. (shrink)

An empirical exploration of the effects on legislative structure, distribution of influence, power, and decision outcomes, of recent changes in the Congress and state legislatures. The book focuses on changes in rules, parties, and committees and the impact or lack of impact of these changes on subsequent activity. Originally published in 1978 by D.C. Heath and Company. Co-published with the Policy Studies Organization.

If Christian theology is that enterprise whose essential purpose is to understand the faith of the Christian Church, then it must approach that faith from the perspective not only of its transcendent source, but also as a human achievement, a creative interpretation of those events in which transcendent reality discloses itself for appropriation. Few theologians would deny that theology has to do primarily with the ways in which ultimate reality becomes manifest in human beings' faithful responses, in belief and trust, (...) to its self-disclosures, preparatory and decisive. But the implications of such a view are not always confronted straightforwardly, especially for the suitable normative principles by which theology must assess the adequacy of the church's expressions of its faith. This essay seeks to probe how an account of the Christian faith could proceed whose norm derives not from the revelatory source of faith but from the dynamic of human creativity within which alone faith's source, in being interpreted, becomes clear, cogent, and decisive for conscious existence. (shrink)