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)

This letter responds to letters by Garson Leder and by Harrison Lee in the same issue, September‐October 2024, of the Hastings Center Report.

Does the practice of questioning the decision-making capacity of patients who disagree with recommended medical interventions amount to paternalism on the part of physicians who would not have raised questions about competence had these patients accepted the recommendation? Brudney and Siegler provide a nuanced argument why the practice can be both pragmatically and ethically justifiable, particularly if physicians follow a “decision tree” that they recommend for cases where disagreements occur. Nonetheless, the history of this subject shows that bioethicists have long (...) been worried that the “outcome approach” (challenging patient’s capacity because of substantive disagreements with their choices) undermines respect for autonomy, and the more refined version from Brudney and Siegler still creates some further concerns about the resulting inadequacies in communication and comprehension in the physician-patient relationship. (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 main point developed in this paper is the demonstration of the attitudes characterizing the major Belgian political parties. This is achieved through a factorial analysis applied to a set of data resulting from the answers given by the major parties leaders to various specific questions regarding bath the prevailing economie as well as institutional issues at the eve of the election of December 17th, 1978. From that point it has been possible to compare those results with the one obtained (...) from the data concerning the 1974 programmes.The results of the statistical analysis show that white in 1974 the strongest positive associations between parties corresponded to tht traditional ethical and socioeconomic cleavages, four years later the linguistic dimension was predominant with a stronger homogeneity characterizing the Dutchspeaking group than what could be observed for the Frenchspeaking one.The factorial analysis allows for a graphical representation of the respective positioning of the parties along the statistically significant factorial axes. Applied to two sets of data, the first one on purely institutional matters, the second one on both institutional and economic policies, the analysis reveals clearly through the various graphs presented the linguistic cleavage as well as the divergences about the extent of regional competences and minorities protection, on the one hand, and, on the other hand, the degrees of regional economic autonomy and of public intervention in the business life. (shrink)

In the article “A Conceptual Model for the Translation of Bioethics Research and Scholarship,” Debra Mathews and her colleagues want to apply to bioethics various translational concepts developed for biomedical research. According to experts in translational science, this would mean evaluating not only the extent to which research produces the “changes in thinking, practice, and policy” that interest Mathews et al. but also the appropriateness of bioethics training and the level of competency of people working in the field. Their proposal (...) thus raises two sets of questions. The first, which the authors recognize must be the starting point for their argument, is, what precisely is the field in question? The second is whether the tools of translational science provide the right means of measuring the achievements of bioethics. (shrink)

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)

Physician aid in dying is a broader topic than euthanasia in that the latter usually refers to active euthanasia, while physician assistance also encompasses the issue of assisted suicide. Volumes could be and have been written on physician-assisted death. But my purpose here is to address a specific aspect of the topic: the policy implications with regard to proposed legislation on physician-aided death.Although the title's reference to physician assistance suggests a focus on the role of the professional, what people often (...) take to be most important and at the heart of the topic is the issue of the patient's rights, usually seen as being manifested in four different ways. First is the right to a dignified death, as free from pain and suffering as possible. In crossing national boundaries and preceding the organization of the professions and the creation of societies, this right is viewed as one that ought to be recognized. (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.

Mea culpa. In 1981 the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, of which I was the Executive Director, recommended to the President and Congress that all federal departments and agencies that conduct or support human subjects research adopt “as a common core” the HHS regulations, “while permitting additions needed by any department or agency that are not inconsistent with these core provisions.” The commission believed—rightly, I still think—that having uniformity would ease (...) administration, reduce regulatory burdens, simplify oversight, and make research more efficient. Yet our naïve expectation the task could be accomplished in 180 days meant that we failed to anticipate that if it took much longer—namely, the 10 years that passed before the Common Rule was issued—federal officials would thereafter be reluctant to change the regulations and that when they tried to do so twenty years later, with the issuance of the ANPRM in 2011, they would propose comprehensive revisions. I argue that was the wrong conclusion to draw from the difficulties in issuing the first Common Rule, and that the process of producing the new “final rule” on January 19, 2017—during which many of the proposed changes were either dumped or promulgated without being adequately vetted—reinforces the conclusion that a more incremental process, with ongoing involvement of the public through an advisory body like the President's Commission, would be a much better way to proceed. (shrink)

At every moment, somewhere in the world, a group of men and women are sitting around a table deliberating about an ethical issue posed by medicine and research, whether as a research ethics committee; a hospital or clinical ethics committee; a stem‐cell review committee; a gene transfer research committee; a biobank ethics committee; an ethics advisory committee for a medical or nursing association or nongovernmental organization; a state, provincial, national, or intergovernmental bioethics committee; or an ad hoc panel examining a (...) particular development or case. However, the last national committee in the United States, the Presidential Commission for the Study of Bioethical Issues, held its final meeting at the end of August 2016 and closed its doors. Should we regret its departure? I believe that the United States would benefit from having another national bioethics advisory body, but I do not think that the commission should simply have continued under a new president in the same form. Instead, looking at the experience of that commission and its six predecessors—who they were, how they worked, the functions they served, and the problems they experienced—we can derive some useful ideas for anyone planning to build the next commission. (shrink)

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.

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.

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)

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 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)

: 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.

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)

Biomedical and behavioral research is a complex, multidisciplinary, and highly varied enterprise with but a single goal: to produce and disseminate knowledge about the causes, effects, prevention, diagnosis, and treatment of human illnesses and impairments. Success requires public trust in the process. When that trust has been shaken (or worse), the response has been to establish offices to exercise oversight of the various actors and to require them to adhere to regulations that specify, with various levels of detail, what they (...) may or may not do.The two regulatory frameworks examined in this report by Barbara Bierer and Mark Barnes began separately, provoked by different scandals and abuses of public trust. (shrink)

[1] ʻAl ʻinyene ḥinukh ha-banim ṿeha-banot ṿi-yeme ha-baḥarut-- [2] ʻAl ʻinyene derekh ha-Ḥasidut lesayeaʻ le-zulato be-ruḥaniyut ṿe-nilṿeh elaṿ mikhteve ḳodesh be-ʻinyan zeh.

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.”.