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 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)

The National Institutes of Health and other federal health agencies are considering establishing a national biobank to study the roles of genes and environment in human health. A preliminary public engagement study was conducted to assess public attitudes and concerns about the proposed biobank, including the expectations for return of individual research results. A total of 141 adults of different ages, incomes, genders, ethnicities, and races participated in 16 focus groups in six locations across the country. Focus group participants voiced (...) a strong desire to be able to access individual research results. Recognizing the wide range of possible research results from a large cohort study, they repeatedly and spontaneously suggested that cohort study participants be given ongoing choices as to which results they received. (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)

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)

In lieu of an abstract, here is a brief excerpt of the content:Bioethics Commissions: Town Meetings with a “Blue, Blue Ribbon”Susan Cartier Poland (bio)Town meetings are characteristic of New England. In theory, a quorum of registered voters in a small municipality meets annually to decide local public policy. In fact, special interests and the town bureaucracy control the meeting.Like a town meeting, a commission (or committee or council) comes into being, whether on an ad hoc or permanent basis, to direct (...) a government function. Bioethics commissions specialize in one area: the intersection of public policy with developments, either real or anticipated, in the basic and applied sciences.That specialization of commissions carries over into the selection of the members. More often than not commission members are appointed on the basis of expertise in a specific area. Although some commissions are still made up entirely of one kind of expert, usually medical, the majority of these government bodies seek breadth between the fields of law, religion, ethics, and science (including medicine and the social sciences).In the words of Mrs. Rigenbach, the law clerk to Chief Judge Carl B. Rubin of the United States District Court for the Southern District of Ohio, selection of persons “knowledgeable in the field” constitutes a “blue, blue ribbon” jury. In contrast, a “blue ribbon” jury is composed of those persons having “the greatest amount of formal education” (In re Richardson-Merrill, Inc. (Bendectin litigation), 624 Federal Supplement 1212 at 1217 (1985)). The problem with persons knowledgeable in the field is that their minds may have already been made up. For a jury, this is a disaster; for a bioethics commission, this directs and shapes the research, investigation, and discussion, or, in short, it makes for more efficient decision making.For this Scope Note, the definition of commission begins with the Bioethicsline description of its index term “advisory committees” as committees or commissions set up to advise government bodies on public policy. Furthermore, a commission [End Page 91] (or committee) receives government funding and support in exchange for its expertise in research, investigation, reporting, and recommendations.Six functions served by bioethics commissions have been clearly and succinctly described by LeRoy Walters (Commissions and Bioethics. Journal of Medicine and Philosophy 14 (4): 363–68, August 1989). The functions are: (1) to legitimize action; (2) to delay action or resolution; (3) to identify duplication; (4) to be representative; (5) to do research and find facts; and (6) to provide education and support (pp. 364–65). Since 1989, however, another government function has moved to the forefront. Instead of remaining within the legislative arena, government commissions serve the judiciary as well, in cases involving complex and technical questions. The now defunct Law Reform Commission of Canada recognized this use when it included in its annual reports a section on its “Influence on Law Reform through Judicial Decisions.”In mid-1997, the United States Supreme Court in its consolidated cases on assisted suicide used extensively the writings from a state commission, the New York State Task Force on Life and the Law, to support its rationale. Not only did the Court make use of the Task Force’s work, but in so doing the Court extended the efforts of the commission beyond its jurisdiction of New York into another jurisdiction on the opposite coast, Washington state. Furthermore, although the commission was chartered by one state, through the federal court system, its influence became national.Outside the U.S., the United Nations recently adopted its first bioethics text on the ethics of genetic research, and Canada is reworking its human research guidelines into a single set of guidelines that will apply to research in both the natural sciences and the social sciences.This Scope Note attempts to compile for the researcher and the reference librarian those commissions, existing and defunct, that have addressed bioethics issues. Only one other such attempt is known to the author, an Office of Technology Assessment [OTA] Background Paper, Biomedical Ethics in U.S. Public Policy (1993). Due to space limitations, not all publications could be listed; the selections included represent the range of topics from a particular group or the more frequently cited sources. Future updates of this compilation are planned, so please notify the... (shrink)

This chapter contains sections titled: Legal Interventions First Nations Remains as Protected by First Nations Heritage and Jurisprudence Search for Professor Ermine's ‘Ethical Lodge’ Conclusion References.

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)

Discusses Locke's life and views and their impact on American philosophy, as well as his role in the Harlem Renaissance.

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)

IN THE CHRISTIAN TRADITION, IT IS GENERALLY AGREED THAT THE DOCTRINE OF THE TRINITY REPRESENTS CHRISTIANITY’S MOST CAREFULLY ARTICULATED CONCEPTUALIZATION OF DIVINE BEING. AS PAUL TILLICH HAS POINTED OUT, TRINITARIAN "THINKING" IS PRESENT IN MANY RELIGIOUS TRADITIONS, BUT THERE IS NOTHING LIKE A "DOCTRINE" OF THE TRINITY TO BE FOUND EXCEPT IN CHRISTIANITY. THIS ESSAY ATTEMPTS TO SHOW THAT, PRECISELY AS DOCTRINE, TRINITARIANISM REPRESENTS A UNIQUE CONTRIBUTION TO HUMANKIND’S REFLECTION ABOUT TRANSCENDENT REALITY.

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.

The literatures on both authentic leadership and behavioral integrity have argued that leader integrity drives follower performance. Yet, despite overlap in conceptualization and mechanisms, no research has investigated how authentic leadership and behavioral integrity relate to one another in driving follower performance. In this study, we propose and test the notion that authentic leadership behavior is an antecedent to perceptions of leader behavioral integrity, which in turn affects follower affective organizational commitment and follower work role performance. Analysis of a survey (...) of 49 teams in the service industry supports the proposition that authentic leadership is related to follower affective organizational commitment, fully mediated through leader behavioral integrity. Next, we found that authentic leadership and leader behavioral integrity are related to follower work role performance, fully mediated through follower affective organizational commitment. These relationships hold when controlling for ethical organizational culture. (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)

This book proposes an alternative to the consent model which is currently at the heart of patient self-determination and which is shown here to have fundamental flaws that constrain its effectiveness. The proposed model is a property model in which the patient’s bodily integrity is protected from unauthorised invasion, and their legitimate expectation to be provided with the relevant information to make an informed decision is taken to be a proprietary right. This model enables the courts to overcome the requirement (...) to prove causation in consent cases and offers a complementary approach to patient self-determination. (shrink)

: 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)

The individualism and restless mobility of modernity have become disorienting and frightening. Our nostalgia for premodern times when natural bonds to kith and kin were unshakable continues to surface, most recently in the popular phenomenon of support groups. On Community examines this crucial philosophical issue of community for the postmodern mind by presenting 13 readable, original essays by some of the top experts currently working on this problem. The first four essays, by Eliot Deutsch, R. W. Hepburn, Hilary Putnam, and (...) Leroy S. Rouner, examine philosophies of community, emphasizing metaphysical analysis and definition of the nature of community. The second section considers the theme in a cross-cultural context. Merry I. White, Katherine Platt, Benjamin Schwartz, and Huston Smith illustrate in this section the various ways in which community is understood and experienced in Japan, North Africa, China, and India. The final section, which contains contributions by Patrick Hill, Jurgen Moltmann, Catherine Keller, and George Rupp, explores the future of community, focusing on community building in Western societies. While the authors represent diverse interests, they also share common ground. Virtually all agree that a creative community needs some form of individualism in order to make a community effective. And there is a consensus among the essays that community is a good thing and that the quest for community in our time is a significant fact. Finally, the contributors suggest that the critique of the liberal view of the autonomous individual, in vogue in recent years, now seems to have waned. (shrink)