LeRoy Walters

Human Embryonic Stem Cell Research: An Intercultural Perspective

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.

When Is Termination of Pregnancy during the Third Trimester Morally Justifiable

The question whether to terminate pregnancy during the third trimester involves a moral conflict. We argue that such termination is morally justifiable if two conditions are fulfilled: first, that the fetus is afflicted with a condition that is either incompatible with postnatal survival for more than a few weeks or characterized by the total or virtual absence of cognitive function; and second, that highly reliable diagnostic procedures are available for determining prenatally that the fetus fulfills either of the two parts of the first condition. At present, one entity, anencephaly, clearly fulfills both conditions. We studied 10 cases involving fetuses with sonographically diagnosed anencephaly that were aborted during the third trimester. We also examined other fetal disorders and conclude that they do not clearly fulfill our two conditions for the justifiable termination of pregnancy in the third trimester.

Safety issues in cell-based intervention trials

We report on the deliberations of an interdisciplinary group of experts in science, law, and philosophy who convened to discuss novel ethical and policy challenges in stem cell research. In this report we discuss the ethical and policy implications of safety concerns in the transition from basic laboratory research to clinical applications of cell-based therapies derived from stem cells. Although many features of this transition from lab to clinic are common to other therapies, three aspects of stem cell biology pose unique challenges. First, tension regarding the use of human embryos may complicate the scientific development of safe and effective cell lines. Second, because human stem cells were not developed in the laboratory until 1998, few safety questions relating to human applications have been addressed in animal research. Third, preclinical and clinical testing of biologic agents, particularly those as inherently complex as mammalian cells, present formidable challenges, such as the need to develop suitable standardized assays and the difficulty of selecting appropriate patient populations for early phase trials. We recommend that scientists, policy makers, and the public discuss these issues responsibly, and further, that a national advisory committee to oversee human trials of cell therapies be established.

The licensing of DNA patents by US academic institutions: an empirical survey

A survey of technology transfer of DNA inventions at 19 top US research universities reveals consensus, diversity and flexibility in intellectual property management. Patent filing and license terms are influenced by intended uses of inventions, outside market interest and NIH guidelines.

The Data and Safety Monitoring Board and Acquired immune deficiency syndrome (AIDS) clinical trials

The urgency of the Acquired immune deficiency syndrome (AIDS) epidemic has mandated that multiple therapeutic approaches be developed and that these approaches be evaluated through clinical trials. To oversee these trials, the National Institute of Allergy and Infectious Diseases (NIAID) has created three large clinical trial programs monitored by a Data and Safety Monitoring Board (DSMB). For each clinical trial, this Board uses a standardized approach employing contemporary biostatistical, medical, and ethical principles. The DSMB is responsible for reviewing interim data on clinical trial performance, treatment safety and efficacy, and overall study progress. If interim results provide convincing evidence of either excessive adverse effects or significant treatment benefit, the DSMB may recommend early termination of the trial to the NIAID and the study investigators. The responsibility, organization, and operating procedures of this DSMB are presented and illustrated through three clinical trials sponsored by NIAID and monitored by the Board. The rationale and operational model for the DSMB may be a useful example for the development of similar review processes in other HIV clinical trial settings.

Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board.

Data Safety Monitoring Committees (DSMB) for large, long-term randomized trials of agents in common use face challenging problems especially when the emerging data indicate unanticipated effects. The DSMB for the Womens Health Initiative Clinical Trials, on observing early indication of a surprising adverse cardiovascular effect of post-menopausal hormones, spent several years deliberating what recommendations it should make. This paper describes the dilemmas faced by the DSMB and the considerations it made over the course of its existence. The paper concludes with some recommendations for other DSMBs.

Ethics and new reproductive technologies: an international review of committee statements.

Walters examines the statements of advisory committees in eight countries on new practices involving human reproduction: clinical in vitro fertilization; surrogate motherhood; and human embryo research. He analyzes the positions taken by the committees on the general acceptability of the new technologies, as well as on specific issues involved in assisted human reproduction. In chronological order, the statements examined are those of the U.S. Ethics Advisory Board; the Waller committee in Victoria, Australia; a South Australian committee; the Demack committee in Queensland; Britains Council for Science and Society; Britains Warnock committee; a Tasmania, Australia, committee; the Ontario Law Reform Commission; Australias Family Law Council; West Germanys Benda committee; the American Fertility Society; a Western Australia committee; the Dutch Health Council; and the National Ethics Committee of France.

Genetics and bioethics: How our thinking has changed since 1969

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.

Ethical Issues in Intrauterine Diagnosis and Therapy

This essay considers ethical problems raised by recent developments in intrauterine diagnosis and therapy. Diagnostic and therapeutic innovations applicable to the previable fetus and to the possibly viable or viable fetus are briefly described. A central ethical issue prior to viability is whether intrauterine therapy for fetal health problems should be attempted or whether selective abortion should be chosen as an alternative. Beyond viability, an important question is the extent to which a pregnant woman is morally obligated to accept risks to her own life or health for the sake of the fetus.

Religion and the Renaissance of Medical Ethics in the United States: 1965–1975

In this essay I will seek to justify three claims: (1) that the field of medical ethics underwent a qualitative shift in the United States in the decade between 1965 and 1975; (2) that several thinkers interested in the relationship between religion and science and between religion and ethics contributed significantly to this shift; and (3) that two Catholic laymen, Daniel Callahan and Andre Hellegers, and one Protestant theologian, Paul Ramsey, were among the principal institutional and intellectual architects of the recent renaissance in medical ethics.