This article highlights major results of a study into the ethical norms and rules governing biobanks. After describing the methodology, the findings regarding four topics are presented: (1) the ownership of human biological samples held in biobanks; (2) the regulation of researchers’ use of samples obtained from biobanks; (3) what constitutes “collective consent” to genetic research, and when it is needed; and (4) benefit sharing and remuneration of research participants. The paper then summarizes key lessons to be drawn from the (...) findings and concludes by reflecting on the importance of such empirical research to inform future governance norms and practices. (shrink)

People do not choose to suffer from catastrophic illnesses, but considerable human choice is involved in the ways in which the participants in the process treat and conduct research on these diseases. Catastrophic Diseases draws a powerful and humane portrait of the patients who suffer from these illnesses as well as of the physician-investigators who treat them, and describes the major pressures, conflicts, and decisions which confront all of them. By integrating a discussion of "facts" and "values," the authors highlight (...) the forces which affect new developments in medicine—such as kidney and heart transplants—and the controversial issues they generate. Katz and Capron explore these issues through the use of dual conceptual perspectives. Their study first examines and evaluates the authority which should be vested in each of the chief participants in the catastrophic disease process—the physician-investigator, the patient-subject and his relatives, the professionals, and the state. Challenging questions are raised concerning medical education, informed consent, and professional responsibility. The authors next explore how the roles and capacities of the participants vary not only according to the basic issues they face but also according to the point in decision-making at which these issues arise. The process of investigating and treating catastrophic diseases, the authors believe, can thus usefully be divided into three decision-making stages—the formulation of policy, the administration of research and therapy, and the review of the decisions and their consequences. In conclusion, Katz and Capron demonstrate the need for a variety of individuals and groups with diverse values to be involved in decision-making in a manner which will not unnecessarily impede the scientific investigation of these diseases. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Human Genome Research in an Interdependent WorldAlexander Morgan Capron (bio)This has been the year of agenda-setting conferences for the ambitious ELSI (ethical, legal and social issues) program of the Human Genome Project (HGP). But of the dozen or more major meetings of this sort held across the country, the one held at the National Institutes of Heakh (NIH) in Bethesda, MD, June 2-4, 1991, was distinctive in (...) several respects.1As its name implies, "Human Genome Research in an Interdependent World" was a global look at the issues raised by gene mapping and sequencing. Unlike previous conferences, however, this meeting looked beyond a comparative analysis of clinical and domestic legal issues, and concentrated on topics that may require responses on a truly international level if they are to be successfully resolved.The meeting's organizers gathered an impressive group of more than seventy participants from fifteen countries, including the first significant contingent of Soviet and Japanese scientists, physicians, and philosophers at an ELSI meeting. In addition to talks by the heads of the genome projects in the Soviet Union, Japan, and the United States, the meeting was keynoted by Dr. James Wyngaarden, director general of the Human Genome Organization (HUGO), and I had the honor of serving as its general chairman.The goal of the meeting was to consider an array of issues that scientists, philosophers, and lawyers from around the world suggested might have international significance, with an eye to deciding three things: (1) Does the issue deserve further attention? (2) Is the issue best addressed in an international or domestic context? and (3) Do structures exist to which the issue can be referred for resolution? In the final sessions, the entire group debated proposed resolutions on the various topics and narrowed the list needing further, intensive exploration.To provide an international framework for this process, the conference [End Page 247] established a Global Steering Committee on Ethical and Social Issues in Genome Research, which will coordinate the efforts of several task forces charged with refining the tentative resolutions adopted by the conference participants on June 4. The task forces are expected to be able to complete work on some topics by the time of the steering committee's first meeting, which was described by one participant as a "check point," probably within the coming year; on other topics, the task forces will provide interim reports and arrange to continue their analysis. Several topics—less complex or more embryonic—were referred directly to the steering committee. On all issues, a major objective will be to ascertain what existing or newly created structure or structures are capable of implementing the group's recommendations and then to monitor the issue to ensure that appropriate implementation is occurring.Issues to be Explored by Task ForcesInsurance and EmploymentWhile individuals may derive medically useful information from the expanded range of genetic tests that will flow from the HGP, they could also be harmed if test results become a basis for discrimination. An area of particular concern at the conference in Bethesda was whether genetic information should be used to decide eligibility for employment or the scope and cost of health and life insurance. The complexity of this issue is increased as barriers to worker migration fall (especially in Europe) and as more firms carry on business internationally. Furthermore, questions arise about the limits of required testing and whether individuals may decline to be informed of the results of tests.The task force will not only gather information on practices and legal standards throughout the world—especially in light of the differences among nations with regard to the linkage of employment and various forms of insurance—but will also examine international anti-discrimination laws as a possible means of supplementing domestic statutes and regulations. As a starting point, the Bethesda meeting agreed on a set of principles for the task force to refine.2ForensicsAlthough their legal status is not fully resolved, DNA tests are being used increasingly in judicial proceedings and civil and criminal investigations as a highly probative means to identify people. Most forensic uses of "DNA fingerprints" are domestic, but international cooperation among investigative bodies... (shrink)

To understand the future of informed consent, we should pay attention to two ethical-legal sources in addition to the revised Common Rule. Physicians acting as investigators and patients serving as research subjects bring to that relationship a long history regarding consent to treatment, and everyone dealing with research ethics needs to be aware of the Nuremberg Code and other human-rights documents. These three streams make separate and distinctly different contributions to informed consent doctrine.

In lieu of an abstract, here is a brief excerpt of the content:An Egg Takes Flight: The Once and Future Life of the National Bioethics Advisory Commission*Alexander Morgan Capron (bio)Attempting to describe the National Bioethics Advisory Commission (NBAC) is comparable to the surreal feat performed by the artist in a famous painting by René Magritte. The artist (Magritte himself) sits with his back to the viewer, a palette in his left hand. The brush in his right hand is (...) raised to a canvas, blank except for a bird in flight that he is in the process of painting. The artist is looking to his left at a tabletop, bare except for a single, plain egg.Having held its second formal meeting in mid-January, NBAC is certainly still embryonic, its future mysterious within its shell. Yet answers to four major questions that will determine not just what kind of bird the Commission turns out to be but the heights to which it will fly should be evident by April or May 1997. First, will the White House take the sort of interest in NBAC that is needed if it is to succeed? Second, will the Commission’s term be extended beyond October 1997—and will the decision come early enough to allow it to start soon on projects that will take more than a single year to complete? Third, will the Commission take a broad view of the issues it addresses, reexamining widely accepted assumptions and going back to basic premises, or will it respond primarily in bureaucratic terms, guided by its charter’s focus on improving the policies and practices of federal departments and agencies? Fourth, will the Commission move beyond its initially mandated topics—the rights and welfare of human research subjects and the management and use of genetic information—and become what its name promises, the nation’s advisory body on the full range of bioethical issues that arise in the organization and management of health services and research?The Origins of the Egg: NBAC’s PredecessorsThe creation of a national bioethics commission has been demanded for years, at the least since its most recent predecessor, the Biomedical Ethics [End Page 63] Advisory Committee (BEAC) finally expired in 1990. BEAC’s statutory authority lapsed after the hapless committee had spent several years itself like an in vitro embryo in a vat of liquid nitrogen. BEAC’s opponents in Congress froze its appropriation and forbad it to meet until the Biomedical Ethics Board of six senators and six representatives to which it was supposed to report resolved the chaos resulting from the Board members’ ideological differences and personal distrust; this never occurred, and the Board proved unable even to choose its chairman. 1 BEAC, which met only twice, had laid preliminary plans to study the issues raised by the new genetics, but the politics of abortion—which had greatly complicated and slowed the Board’s naming of the BEAC members—was strong enough to interfere even with the topic of genetics, on which the difference among committee members actually gave no sign of dividing on pro-life/pro-choice grounds.The disappearance of BEAC left the nation without a mechanism for “public bioethics,” and several efforts were undertaken in the early 1990s to generate a new commission that could carry on in the tradition of the two previous, successful bioethics commissions. (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research operated under a Congressional mandate in the Department of Health, Education, and Welfare from 1974 to 1978, and the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, which had been authorized by Congress in 1978, actually operated as an independent body with government-wide purview from January 1980 to March 1983.) The Institute of Medicine established a committee to assess the mechanisms available not only to the federal government but also to states, professional bodies, and the public for deliberating about and resolving ethical issues stemming from developments in biomedicine (Bulger, Bobby, and Fineberg 1995). In September 1992, Senators Mark O. Hatfield (R-OR), Edward M. Kennedy (D-MA), and Dennis DeConcini (D-AZ) requested that the Office of Technology Assessment (OTA) evaluate the... (shrink)

ABSTRACT The IAB Presidential Address was delivered by Alexander Capron to the internationally gathered audience at the Closing Ceremony of the 8th World Congress of Bioethics, Beijing on 9th August 2006.

A few years ago a battered infant was admitted to a California hospital. After a period of observation and testing, the physicians concluded that the infant had been beaten so badly that his brain was almost completely destroyed, leaving him permanently unconscious. The hospital had just adopted a policy specifying that life-sustaining treatment for permanent unconsciousness was futile and, therefore, not indicated. According to this policy, after suitable subspecialty consultations and deliberations, including efforts to gain parental agreement and documentation of (...) unanimous ethics committee support, the patient's physician had the authority to discontinue life-sustaining treatment. The infant's physician wished to do this. The mother, however, who was the prime battery suspect, insisted that the baby be kept alive. (shrink)

In transplant medicine, the use of normothermic regional perfusion (NRP) in donation after circulatory determination of death raises ethical difficulties. NRP is objectionable because it restores the donor's circulation, thus invalidating a death declaration based on the permanent cessation of circulation. NRP's defenders respond with arguments that are tortuous and factually inaccurate and depend on introducing extraneous concepts into the law. However, results comparable to NRP's—more and higher‐quality organs and more efficient allocation—can be achieved by removing organs from deceased donors (...) and using normothermic machine perfusion (NMP) to support the organs outside the body, without jeopardizing confidence in transplantation's legal and ethical foundations. Given the controversy that NRP generates and the convoluted justifications made for it, we recommend a prudential approach we call “ethical parsimony,” which holds that, in the choice between competing means of achieving a result, the ethically simpler one is to be preferred. This approach makes clear that policy‐makers should favor NMP over NRP. (shrink)

: The appearance of a sheep named Dolly, the first clone of an adult mammal, dramatically affected the agenda, pace of work, and visibility of the National Bioethics Advisory Commission. The Commission's approach to its task and some of the issues it considered in responding to President Clinton's request for review and recommendations within 90 days are described.

The Covid‐19 pandemic has brought bioethics back to five topics—justice, autonomy, expert authority, religion, and judicial decisions—that were central during its formative period but has cast a new light on each, while also tangling public health policy in the current, rather radical, reshaping of the role of organized religion in society.

Proposals to use organs from anencephalic infants to meet the growing need for transplantable ogans are well‐meaning but misguided. It would be unwise to amend the Uniform Determination of Death Act to classify anencephalics as “dead.” They are in the same situation as other patients (such as the permanently comatose). Likewise, amending the Anatomical Gin Act to permit organs to be removed from anencephalics would be unjust would set a bad precedent and would likely reduce overall success in this field.

The intense media coverage of the latest version of “human cloning” that began in mid‐October with a front‐page story in the New York Times revealed more than the public's deep fascination with the prospect of endless human replicas.1 It also served as a reminder that for the past decade no official, broad‐based advisory bioethics body has operated in the United States.

In 1990, I voiced strong doubts about a bill entitled the Patient Self-Determination Act, which had been introduced in the U.S. Senate by John Danforth and Daniel Patrick Moynihan. I hoped to see it defeated. In 1991, after the bill had become a small part of a massive status adopted in the waning hours of the 101st Congress, I devoted countless hours to its implementation. I wanted to see it succeed. Why the change?

Since their initial authorization by Congress in 1985, the Bio‐medical Ethics Board and its advisory body, the Biomedical Ethics Advisory Committee, have led a precarious and often politically troubled existence. Today, they are poised to take up their mandate to examine “the ethical, social, and legal implications of advances in biomedical research and technology.”.

The modern history of experimentation with human beings is notable for its ethical lacunae. In 1865, in his great work, An Introduction to the Study of Experimental Medicine, Dr. Claude Bernard, the French physician who first established the use of the scientific method in medicine, echoed the earlier injunctions of physician-moralist Moses Maimonides in counseling his fellow physicians not to treat their patients solely as a means of advancing knowledge. Yet such cautions had no apparent effect on the physicians who, (...) at the end of the 19th century, studied the transmission of venereal diseases by intentionally infecting poor and institutionalized people without their knowledge, much less their consent. In response... (shrink)

Over the last decade, standards for when and how to undertake a wide range of medical interventions have poured forth from medical specialty groups, commercial and nonprofit organizations, and state and federal panels. Known by a variety of names—from practice parameters to clinical guidelines—and intended for a range of purposes—from diminishing the incidence of maloccurences in hospitals to cutting the costs of health care—these guidelines share one important feature: the intention of decreasing the range of variation in medical practice. Such (...) standardization immediately appeals to anyone interested in improving the quality of health care and, in particular, reducing inappropriate medical interventions, in light of the difficulties for a conscientious physician today in adhering to the best standard of practice when faced with ever increasing medical knowledge and the growing number and complexity of diagnostic, preventive, and therapeutic interventions. (shrink)

Over the last decade, standards for when and how to undertake a wide range of medical interventions have poured forth from medical specialty groups, commercial and nonprofit organizations, and state and federal panels. Known by a variety of names—from practice parameters to clinical guidelines—and intended for a range of purposes—from diminishing the incidence of maloccurences in hospitals to cutting the costs of health care—these guidelines share one important feature: the intention of decreasing the range of variation in medical practice. Such (...) standardization immediately appeals to anyone interested in improving the quality of health care and, in particular, reducing inappropriate medical interventions, in light of the difficulties for a conscientious physician today in adhering to the best standard of practice when faced with ever increasing medical knowledge and the growing number and complexity of diagnostic, preventive, and therapeutic interventions. (shrink)

This chapter contains sections titled: What Are Advance Directives and Why Do We Have Them? The Origins, and Limitations, of the “Living Will” Legislatively Authorized “Instruction Directives” Legislatively Authorized “Appointment Directives” Advance Directives Outside the United States Conceptual Problems and Practical Difficulties Barriers Remaining to the Effective Use of Advance Directives References Further reading.

The Jewish philosopher and educator Martin Buber (1878–1965) is considered one of the twentieth century’s greatest contributors to the philosophy of religion and is also recognized as the pre-eminent scholar of Hasidism. He has also attracted considerable attention as a philosopher of education. However, most commentaries on this aspect of his work have focussed on the implications of his philosophy for formal education and for the education of the child. Given that much of Buber’s philosophy is based on dialogue, on (...) community and on mutuality, it is puzzling that relatively little has been written on the implications of Buber’s thought for the theory and practice of non-formal adult education. The article provides a discussion of the philosophy underpinning this aspect of Martin Buber’s life and work, and its implications for adult non-formal education. (shrink)

Martin Buber (1878-1965) is one of the most significant existentialist philosophers of the twentieth century and a leading scholar of the Hasidic tradition in Judaism; even more important for this article is that Buber is considered by many to be the philosopher of dialogue par excellence. This article expounds Buber’s conception of dialogue and its implications for our conception of the Other.

Many women professionals traverse settings beyond the office in their work, but research on women professionals rarely follows them out of the office. Using a large, archived data set of focus groups with sales professionals, the authors ask how work in out-of-the-office settings affects women’s careers. The authors distinguish between two types of settings. In “heterosocial” settings, interaction rules are traditionally and normatively gendered; women and men are understood by others as heterosexually linked pairs, women become targets of gossip, and (...) some women report sexual advances and sexual harassment. In “homosocial” settings such as golf courses and strip clubs, women’s disadvantage takes the form of exclusion. (shrink)

Medical tourism is the practice of traveling across international borders with the intention of accessing medical care, paid for out-of-pocket. This practice has implications for preferential access to medical care for Canadians both through inbound and outbound medical tourism. In this paper, we identify four patterns of medical tourism with implications for preferential access to care by Canadians: Inbound medical tourism to Canada’s public hospitals; Inbound medical tourism to a First Nations reserve; Canadian patients opting to go abroad for medical (...) tourism; and Canadian patients traveling abroad with a Canadian surgeon. These patterns of medical tourism affect preferential access to health care by Canadians by circumventing domestic regulation of care, creating jurisdictional tensions over the provision of health care, and undermining solidarity with the Canadian health system. (shrink)

This paper is the report of a meetingthat gathered many of the UK's most senioranimal scientists with representatives of thefarming industry, consumer groups, animalwelfare groups, and environmentalists. Therewas strong consensus that the current economicstructure of agriculture cannot adequatelyaddress major issues of concern to society:farm incomes, food security and safety, theneeds of developing countries, animal welfare,and the environment. This economic structure isbased primarily on competition betweenproducers and between retailers, driving foodprices down, combined with externalization ofmany costs. These issues must be addressed (...) by acombination of legislation, restructuring ofthe market, and use of public funds. Themeeting included workshops that made otherrecommendations for research and education. Themost urgent requirement is recognition thatchange is needed and development of a visionfor what that change must achieve. (shrink)