: Because an influenza pandemic would create the most serious hardships for those who already face most serious hardships, countries should take special measures to mitigate the effect of a pandemic on existing social inequalities. Unfortunately, there is little evidence that anybody is thinking about that.

Pregnant women and their interests have been underrepresented in health research. Little is known about issues relevant to women considering research participation during pregnancy. We performed in-depth interviews with 22 women enrolled in either one of two trials sponsored by the National Institutes of Health to assess the safety and immunogenicity of the H1N1 vaccine during pregnancy. Three themes characterized women’s decisions to participate in research: they valued early access to the vaccine, they perceived a safety advantage when participating in (...) research, and they wanted to help advance scientific knowledge. However, there were also some considerations that would disincline them to participate in research—for instance, a significant risk of maternal or fetal harm, the presence of a placebo arm in a study, or a requirement to significantly change planned therapy or behavior. Pregnant women who participated in the H1N1 vaccine trials viewed research favorably, citing its advantages over standard clinical care. These findings emphasize that access to benefit should guide policy for including pregnant women in research. (shrink)

The prospect of using cell-based interventions to treat neurological conditions raises several important ethical and policy questions. In this target article, we focus on issues related to the unique constellation of traits that characterize CBIs targeted at the central nervous system. In particular, there is at least a theoretical prospect that these cells will alter the recipients' cognition, mood, and behavior—brain functions that are central to our concept of the self. The potential for such changes, although perhaps remote, is cause (...) for concern and careful ethical analysis. Both to enable better informed consent in the future and as an end in itself, we argue that early human trials of CBIs for neurological conditions must monitor subjects for changes in cognition, mood, and behavior; further, we recommend concrete steps for that monitoring. Such steps will help better characterize the potential risks and benefits of CBIs as they are tested and potentially used for treatment. (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.

May a doctor treat a patient, despite that patient's refusal, when in his professional opinion treatment is necessary? This is the dilemma which must from time to time confront most physicians. An examination of the validity of such a refusal is provided by the present authors who use the case history of a patient refusing treatment, for cancer as well as for a fractured hip, to evaluate the grounds for intervention in such circumstances. In such a situation the patient is (...) said to have a 'false belief' and it is the doctor's duty to try to change that belief in the patient's interest. The false belief is considered here in terms of the liberty principle, the patient's mental competence and on what is called the 'harm principle' (harm to other individuals or to society). Finally the concept of paternalism is examined. The authors conclude that the doctor must attempt to change a false belief, and if this fails he must examine the patient's mental competence to make the decision to refuse treatment. But in the last analysis the doctor may be under an obligation to respect the patient's refusal. Readers might like to look at (or read again) the papers on 'Liberty' and 'Conscience' published in this Journal under the heading Analysis. (shrink)

The goal of this article is to explore how a social justice framework can help illuminate the role that consent should play in health and science policy. In the first section, we set the stage for our inquiry with the important case of Henrietta Lacks. Without her knowledge or consent, or that of her family, Mrs. Lacks’s cells gave rise to an enormous advance in biomedical science—the first immortal human cell line, or HeLa cells.

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Public health ethics, like the field of public health it addresses, traditionally has focused more on practice and particular cases than on theory, with the result that some concepts, methods, and boundaries remain largely undefined. This paper attempts to provide a rough conceptual map of the terrain of public health ethics. We begin by briefly defining public health and identifying general features of the field that are particularly relevant for a discussion of public health ethics.Public health is primarily concerned with (...) the health of the entire population, rather than the health of individuals. Its features include an emphasis on the promotion of health and the prevention of disease and disability; the collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment; a recognition of the multidimensional nature of the determinants of health; and a focus on the complex interactions of many factors—biological, behavioral, social, and environmental—in developing effective interventions. (shrink)

In bioethics, discussions of justice have tended to focus on questions of fairness in access to health care: is there a right to medical treatment, and how should priorities be set when medical resources are scarce. But health care is only one of many factors that determine the extent to which people live healthy lives, and fairness is not the only consideration in determining whether a health policy is just. In this pathbreaking book, senior bioethicists Powers and Faden confront (...) foundational issues about health and justice. How much inequality in health can a just society tolerate. The audience for the book is scholars and students of bioethics and moral and political philosophy, as well as anyone interested in public health and health policy. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Structural Injustice advances a theory of what structural injustice is and how it works. Powers and Faden present both a philosophically powerful, integrated theory about human rights violations and structural unfairness, alongside practical insights into how to improve them.

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

Like the National Commission and the President's Commission, the Advisory Committee on Human Radiation Experiments was formed to carry out specific ethical tasks. Yet the committee also had an “openness” mission, a charge to investigate allegations that the U.S. government secretly exposed Americans to environmental releases of radiation. Eighteen months later—and after sixteen public meetings, more than 200 interviews, and the review of about 400,000 documents—the committee delivered a 925‐page report to the president.

Confidentiality is a cornerstone of the physician-patient relationship. Breaches of confidentiality in the context of genetic testing are of particular concern for a number of reasons. First, genetic testing reveals information not only about a particular patient, but also about his or her family members. Second,genetic testing can label healthy people as “at risk,” subjecting them to possible stigmatization or discrimination by third parties. Third, as genetic testing becomes more widespread and is incorporated into primary care, breaches of confidentiality might (...) inadvertently occur more frequently because primary care providers may not be trained to understand the uniqueness of genetic information. Until now, genetic services have been provided primarily by medical geneticists and genetic counselors. However, with the proliferation of new genetic presymptomatic and carrier tests, primary care physicians are going to become increasingly involved in genetic testing. Currently, little is known about physicians’ attitudes toward disclosure of confidential genetic information to third parties. (shrink)

Confidentiality is a cornerstone of the physician-patient relationship. Breaches of confidentiality in the context of genetic testing are of particular concern for a number of reasons. First, genetic testing reveals information not only about a particular patient, but also about his or her family members. Second,genetic testing can label healthy people as “at risk,” subjecting them to possible stigmatization or discrimination by third parties. Third, as genetic testing becomes more widespread and is incorporated into primary care, breaches of confidentiality might (...) inadvertently occur more frequently because primary care providers may not be trained to understand the uniqueness of genetic information. Until now, genetic services have been provided primarily by medical geneticists and genetic counselors. However, with the proliferation of new genetic presymptomatic and carrier tests, primary care physicians are going to become increasingly involved in genetic testing. Currently, little is known about physicians’ attitudes toward disclosure of confidential genetic information to third parties. (shrink)

In this article, we address the relevance of J.S. Mill’s political philosophy for a framework of public health ethics. In contrast to some readings of Mill, we reject the view that in the formulation of public policies liberties of all kinds enjoy an equal presumption in their favor. We argue that Mill also rejects this view and discuss the distinction that Mill makes between three kinds of liberty interests: interests that are immune from state interference; interests that enjoy a presumption (...) in favor of liberty; and interests that enjoy no such presumption. We argue that what is of focal importance for Mill in protecting liberty is captured by the essential role that the value of self-determination plays in human well-being. Finally, we make the case for the plausibility of a more complex and nuanced Millian framework for public health ethics that would modify how the balancing of some liberty and public health interests should proceed by taking the thumb off the liberty end of the scale. Mill’s arguments and the legacy of liberalism support certain forms of state interference with marketplace liberties for the sake of public health objectives without any presumption in favor of liberty. (shrink)

Spitale et al. (2024) address a public health ethics question of great importance: How should governments communicate with the public during public health emergencies? The article highlights severa...

Executive Summary There is a general perception that biomedical research has not given the same attention to the health problems of women that it has given ...

Response to Emily A. Largent, Franklin G. Miller and Steven Joffe, A Prescription for Ethical Learning, Hastings Center Report, 43, s1, (S28-S29), (2013).

A new study published in Journal of Medical Ethics by van der Zande et al 1 further highlights why classifying pregnant women as a ‘vulnerable population’ in the context of research is deeply problematic. Because the designation of ‘vulnerable’ is otherwise applied to populations whose decision-making capacity about research participation is somehow compromised—such as children and adults of limited cognitive ability—many of us have been arguing for some time that using this designation for pregnant women is inappropriate and disrespectful.2–4 There (...) is nothing about the state of pregnancy that renders pregnant women incapable of offering valid research consents or refusals. Moreover, rather than protecting the health interests of pregnant women and their offspring, this designation has had the opposite effect. It has contributed to the widespread exclusion of pregnant women from research activities, which is itself pernicious to the health of pregnant women.5 We know that pregnant women encounter a range of health needs across their pregnancies. In the USA, for example, approximately 9 out of every 10 women use some kind of medication during pregnancy to manage health conditions.6 Yet because pregnant women have largely been …. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that women have been (...) inadequately represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

Bioethics is clearly a field in transition, if not confusion. Bioethics began as a scholarly, reflective, academic enterprise. Increasingly, however, some in bioethics are not as interested in producing scholarship as they are in practicing bioethics by providing services to institutions and clients.Bioethics also began as an interdisciplinary line of inquiry, with its major contributors all trained in some established discipline. We were and for the most part still are a field composed of theologians, philosophers, lawyers, physicians, nurses, and social (...) scientists who work in bioethics. Today, however, some young people actually aspire to be bioethicists. Increasingly, they have the option of being trained directly in bioethics, without any other disciplinary background.We are not the first field to find itself engaged in these kinds of transitions. In this short piece, I consider very briefly how two fields--health psychology and epidemiology- have approached similar branch points. (shrink)

Bioethics is clearly a field in transition, if not confusion. Bioethics began as a scholarly, reflective, academic enterprise. Increasingly, however, some in bioethics are not as interested in producing scholarship as they are in practicing bioethics by providing services to institutions and clients.Bioethics also began as an interdisciplinary line of inquiry, with its major contributors all trained in some established discipline. We were and for the most part still are a field composed of theologians, philosophers, lawyers, physicians, nurses, and social (...) scientists who work in bioethics. Today, however, some young people actually aspire to be bioethicists. Increasingly, they have the option of being trained directly in bioethics, without any other disciplinary background.We are not the first field to find itself engaged in these kinds of transitions. In this short piece, I consider very briefly how two fields--health psychology and epidemiology- have approached similar branch points. (shrink)

Television medical dramas frequently depict the practice of medicine and bioethical issues in a strikingly realistic but sometimes inaccurate fashion. Because these shows depict medicine so vividly and are so relevant to the career interests of medical and nursing students, they may affect these students' beliefs, attitudes, and perceptions regarding the practice of medicine and bioethical issues. We conducted a web-based survey of medical and nursing students to determine the medical drama viewing habits and impressions of bioethical issues depicted in (...) them. More than 80% of medical and nursing students watch television medical dramas. Students with more clinical experience tended to have impressions that were more negative than those of students without clinical experience. Furthermore, viewing of television medical dramas is a social event and many students discuss the bioethical issues they observe with friends and family. Television medical dramas may stimulate students to think about and discuss bioethical issues. (shrink)

PURPOSE: The purpose of this paper is to consider some of the philosophical and bioethical issues raised by the creation of the draft social values framework developed to facilitate data collection and country-specific presentations at the inaugural workshop on "Social values and health priority setting" held in February 2011. -/- DESIGN/METHODOLOGY/APPROACH: Conceptual analysis is used to analyse the term "social values", as employed in the framework, and its relationship to related ideas such as moral values. The structure of the framework (...) (process and content values) is considered in light of current debate in philosophy and bioethics about the political and moral aims served by these kinds of values, and the extent to which they are either suited to, or sufficient for, the policy context. -/- FINDINGS: There is much to be gained by engaging with the arguments presented in the philosophical literature in order to further refine the framework. The framework should remain neutral in respect of the importance of procedural values in different contexts and should be as inclusive as possible in respect of the principles it includes. Further development would be best served by taking a multidisciplinary approach. The framework could provide a valuable space in which future debates about procedural/substantive values can be considered. -/- ORIGINALITY/VALUE: The paper brings philosophical and bioethics perspectives to bear on a new framework proposed for the analysis of social values in health priority setting. It identifies how such a practical, policy-focused framework might be informed by engagement with deeper, and often unresolved, questions or principle around resource allocation in health. (shrink)

Television medical dramas frequently depict the practice of medicine and bioethical issues in a strikingly realistic but sometimes inaccurate fashion. Because these shows depict medicine so vividly and are so relevant to the career interests of medical and nursing students, they may affect these students' beliefs, attitudes, and perceptions regarding the practice of medicine and bioethical issues. We conducted a web-based survey of medical and nursing students to determine the medical drama viewing habits and impressions of bioethical issues depicted in (...) them. More than 80% of medical and nursing students watch television medical dramas. Students with more clinical experience tended to have impressions that were more negative than those of students without clinical experience. Furthermore, viewing of television medical dramas is a social event and many students discuss the bioethical issues they observe with friends and family. Television medical dramas may stimulate students to think about and discuss bioethical issues. (shrink)

New biotechnologies have the potential to both dramatically improve human well-being and dramatically widen inequalities in well-being. This paper addresses a question that lies squarely on the fault line of these two claims: When as a matter of justice are societies obligated to include a new biotechnology in a national healthcare system? This question is approached from the standpoint of a twin aim theory of justice, in which social structures, including nation-states, have double-barreled theoretical objectives with regard to human well-being. (...) The first aim is to achieve a sufficient level of well-being in each of six core dimensions. In the special case of healthcare systems, this aim is focally but not exclusively attentive to achieving health sufficiency as one of the core dimensions. The second aim is to combat the emergence and persistence of densely woven patterns of systematic disadvantage that tend to undermine the achievement of a sufficient level of health and the other core elements of well-being of some persons and groups. Judgments about entitlements to health related resources, including new biotechnologies, are made in light of a threshold notion of health sufficiency. What is enough or sufficient health? The answer that is defended here is that sufficient health is enough health for a decent human life, understood as enough health to live a full life course without preventable, significant functional disability or decrement in health, or treatable pain or suffering. When a state must include a new biotechnology in its national healthcare system is also influenced by ancillary concerns about the connection between health and other core dimensions of well-being. What counts as a significant functional impairment or health decrement is thus explicated, in part, in relation to the theory’s sufficiency aim for the other essential dimensions of well-being, and thus for a decent life, overall. Those elements of health that play a critical role in the experience of sufficient reasoning, affiliation, security, respect and self determination are especially important; any loss of health function or capacity that threatens the individual’s prospects for sufficiency in these other dimensions, including the relational egalitiarian concerns they entail, constitutes a significant functional impairment. Within national borders, individuals are thus entitled to those health-related goods and services that are essential for a sufficiency of each of the dimensions of well-being; with regard to self determination and respect, what is sufficient by way of guaranteed access to specific goods and services is going to depend on the implications of such access for where an individual stands in relation to her co-nationals. The content of any entitlement to health-related goods and services is also necessarily dynamic. What can be done for health and the other core dimensions of well-being as a function of technological innovation and diffusion is in constant flux. The paper concludes by considering the implications of this analysis for the conditions under which states are obligated to include access in their healthcare systems to one biotechnology, deep brain stimulation. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Chair’s Perspective on the Work of the Advisory Committee on Human Radiation ExperimentsRuth Faden (bio)On January 15, 1994, President Clinton created the Advisory Committee on Human Radiation Experiments in response to his concern about the increasing number of reports describing alleged unethical conduct of the U.S. Government, and institutions funded by the government, in the use of, or exposure to, ionizing radiation in human beings at the height (...) of the Cold War. He directed the Committee: (1) to uncover the history of human radiation experiments and intentional environmental releases of radiation; (2) to identify the ethical and scientific standards for evaluating these events; and (3) to make recommendations to ensure that whatever wrongdoing may have occurred in the past will not be repeated.The Committee was composed of 14 members: a citizen representative and 13 experts in bioethics, radiation oncology and biology, epidemiology and statistics, public health, history of science and medicine, nuclear medicine, and law. We reported to a cabinet-level group (the Human Radiation Interagency Working Group) convened by the president, which includes the secretaries of defense, energy, health and human services, and veterans affairs; the attorney general; the administrator of the National Aeronautics and Space Administration; the director of the Central Intelligence Agency; and the director of the Office of Management and Budget.On April 21, 1994, at the end of the first day of our first meeting, President Clinton invited us to the White House to personally communicate his commitment to the process we were about to undertake. He urged us to be fair, thorough, and unafraid to shine the light of truth on this hidden and poorly understood aspect of our nation’s past. Our most important task, he said, was to tell the full story to the American public. [End Page 215] At the same time, we were to examine the present, to determine how the conduct of human research today compares with that of the past, and to assess whether, in light of this inquiry, changes need to be made in the policies of the federal government. Eighteen months later, the Committee’s attempt to tell the story of the past and to report on our inquiry into the present was delivered to the president in a 900-page Final Report (ACHRE 1995) and several supplemental volumes.The Committee’s charge was enormous. We were asked to conduct a massive investigation into events that occurred as much as 50 years ago and that involved the highest reaches of the defense establishment and the medical community. This investigation necessitated an examination of the conduct and policies of six federal agencies and countless agents in the private sector, as well as the location and interpretation of hundreds of thousands of documents, many of which were buried in obscure locations or were still classified.In addition, the Committee was instructed to establish standards for judging, in moral terms, the events that it uncovered. This charge necessitated the confrontation of contentious debates in moral thought and theory about history, relativism, and the significance of context in moral judgment. But our purpose was not to engage in these debates in the abstract. Although the Committee was not expressly charged with considering issues relating to remedies, including financial compensation, we felt obliged to address the type of remedies that we believed the government, as an ethical matter, should provide to subjects of experiments where the circumstances warranted such a response. Thus our deliberations about relativism and moral judgment were tied to concrete recommendations for public policy and were conducted in a public context that included participants from numerous adversarial legal proceedings.In tandem with our reconstruction of the past, we undertook three projects to examine the current state of human radiation experiments. First, we studied how each federal agency that currently conducts or funds research involving human subjects regulates and oversees its research activity. Second, from among the very large number of federally-supported research projects involving human subjects, we randomly selected 125 projects for closer scrutiny. We reviewed all available relevant documentation for each project in order to assess how well it appeared to protect the rights and interests of the participating subjects. Third... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Informed Consent and Clinical ResearchRuth Faden (bio)Informed consent is a powerful symbol of the commitment and impact of the new, interdisciplinary field of biomedical ethics that the Kennedy Institute has been so instrumental in developing. In the early years of biomedical ethics, there was considerable discussion about the nature of the doctor-patient relationship, about how it ought to be structured, and about how competing values within that relationship (...) ought to be accommodated. By the 1970s and 1980s, the answer was for all practical purposes in. Biomedical ethics was engaged in a clearly reformist project, in step with the values of the times, to right a wrongful imbalance of power and control between physicians and patients.The agenda was clear—to establish the moral authority of the patient to participate in medical decision making by placing respect for the autonomy of patients on the moral map of the medical community. The chief strategy that biomedical ethics adopted to accomplish this agenda was, of course, informed consent. Theories of autonomous action as well as informed consent were intentionally crafted to advance this reformist agenda.In this paper, I examine how the theory of informed consent has fared in one particular realm of “the clinic” where, arguably, there has been considerable success. This is the realm of clinical research; research at the bedside where the patient is also the subject.I rely heavily on the work of President Clinton’s Advisory Committee on Human Radiation Experiments, which I chaired. The Advisory Committee was established in response to exposés in the press about alleged secret experiments during World War II and the Cold War in which patients had been injected with plutonium without their apparent knowledge or consent. As part of its work, the Advisory Committee undertook an oral history project in which we interviewed eminent physicians about the norms and practices of human research in the 1940s and 1950s.Drawing on these interviews, I argue here for two seemingly inconsistent conclusions. First, that the ethical standards for clinical research have changed dramatically in the last 50 years—particularly with respect to informed consent. Second, that despite these important changes, the human dynamics of clinical research in many respects remain unchanged.How the World of Clinical Research Has ChangedDuring the forties and fifties, duties to obtain informed consent, whether for treatment or for research, were simply not part of the doctor-patient experience. [End Page 356]As one physician told us:In 1945, ‘50, the doctor... was king or queen. It never occurred to a doctor to ask for consent for anything. Doctors weren’t in the habit of telling the patients anything (either). They were in charge and nobody questioned their authority.(Advisory Committee on Human Radiation Experiments 1996, p. 83)This unquestioned authority extended to all decisions about the management of the patient, including whether patients were to receive experimental therapies or otherwise become the subjects of research or experimentation. Physicians were trained to be concerned with risk, and harm, and benefit, in keeping with the Hippocratic tradition. But in most institutions, the permission to try something new and to take unknown risks came, not from the patient, but from the chairman of the department.In part, this broad license reflected the very newness of scientifically grounded medical practice. In the forties and fifties, many potentially therapeutic interventions were newly discovered and in this sense considered experimental, or at least innovative. The level of uncertainty about whether a treatment would work was generally high, whether the treatment was part of a research project or not. Moreover, the formalizing of medical science at the bedside was itself still in its infancy—it was not until 1948 that the first modern clinical trial in which patients were randomized to different treatment and control groups was reported in the literature. Much of the research of this period was informal and unsystematic.Thus, it is not surprising that the physician’s authority to make treatment decisions extended to treatments that were innovative or experimental, regardless of whether these innovative treatments were the subject of formal scientific investigation. What is perhaps more surprising is that physicians often acted the same way—that... (shrink)

This article tries to point out the dialectical and paradoxical character of Eckhart’s thought, which permits him at once to affirm and to negate categories such as being, nothingness, personality, substance, origin, creation, image. In this way, Eckhart can unite a personal-theistic and a non-personal-atheistic view. A dialectical structure can also be seen in Eckhart’s ethics. Further, the dialectical interpretation can elucidate the ambivalence in the concept of the scintilla animae. The origin and aim of Eckhart’s dialectics proves to consist (...) in the concept of non-distinction. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:No-Self, Dōgen, the Senika Doctrine, and Western Views of SoulGerhard FadenNo-Self Versus SoulFrom the very beginning of Buddhism, the concept of no-self (P. anattā, J. muga) has been at the heart of Buddhist thought. Based on this concept, Buddhist apologetics rejected the concept of Atman in the Upanishads as well as Western concepts of soul. Christian authors, on the other hand, see an unbridgeable abyss between what they call (...) "Christian personalism" and Buddhist "rejection of souls."1 However, is there really such a clear-cut distinction? Posing this question means denying it. The no-self doctrine is one of the most intricate concepts within philosophy, and words like "self" and "soul" have countless interpretations. It seems to me that the Buddhist tradition itself has not always realized the crucial point of its fundamental doctrine, just as the Western concepts of "person" and "soul" more often than not fell behind the achievements of Plato and the New Testament. Especially the Theravāda line of Buddhism has developed a very counterintuitive picture of what it is to be a human person. "There is suffering, but there is no self who suffers." The most outstanding philosopher of Mahāyāna Buddhism, Nāgārjuna (ca. 150-250), introduced a more convincing interpretation when he said that according to Buddha the self or soul does neither exist nor not exist. This interpretation too, no less than the Theravāda doctrine, can refer to the early epoch of Buddhism. In the Pāli suttas a monk named Vacchagotta asked the Buddha, "Is there a self?" The Buddha gave no response. Then Vacchagotta asked, "Is there no self?" Again the Buddha was silent.2 In any case, the teaching of no-self leaves room for many divergent interpretations. In this paper, I shall propose to understand it as an original view of what is my true being, a view that has analogues in traditional Western philosophy. The truth is one; philosophy has to demonstrate that the different doctrines are nothing but aspects of a single universe. As for the dogmatic tenets of each religion, I would propose to see them like educators of the individual's thought: they set limits, develop abilities, suggest lines of sight, and the like. [End Page 41]The Concept of No-self in Pāli BuddhismIn the limited space of this essay, I can only give some marginal remarks. For a first approach, let us look at the origins of the no-self concept in the scriptures of Pāli Buddhism. They show clearly the aim of that doctrine: it consists in the liberation from objectifying theories of the soul. In the canonical texts, we find repeatedly the formula of rejecting the five aggregates, the so-called "heaps" (Skt. skhandha, P. khandha) that form the phantom of a persistent ego: body, sensation, conceptualization, volitions, and consciousness. None of these things is really mine. The Buddha tells to his disciples as follows: "Suppose, bhikkhus, people were to carry off the grass, sticks, branches, and foliage in this Jeta's Grove, or to burn them, or to do with them as they wish. Would you think: 'People are carrying us off, or burning us, or doing with us as they wish'?" Of course, the disciples do not think so. It is neither their self nor what belongs to their self. In the same way, the Buddha instructs them to think, the ear is not yours, and the mind is not yours, and so on, and to abandon it all.3In other words, by the teaching of anattā the Buddha invites his disciples to cease identifying their true being with things like body or consciousness. Only what really is mine can be my self. The khandhas seem to be mine. To a certain degree, I can dispose of them. However, really they are not mine; on the contrary, they are my master. The teaching of no-self does not originally mean there is no self, but nothing in this world can be my self. What is my self can never be taken from me. I cannot dispose of it, and on the other... (shrink)

In recent years, the right of employees to know about health hazards in the workplace has emerged as a major issue in occupational health policy. A general consensus has gradually evolved that there is a right to know, and correlatively that there is a moral obligation to disclose relevant information to workers. For example, the National Institute for Occupational Safety and Health, and several other U.S. federal agencies, informed the U.S. Senate as early as July 1977 that ‘workers have the (...) right to know whether or not they are exposed to hazardous chemical and physical agents regulated by the Federal Government.’ In 1980, the Occupational Safety and Health Adminstration promulgated regulations guaranteeing workers access to medical and exposure records. (shrink)

Television medical dramas sometimes depict medical professionalism and bioethical issues, but their nature and extent are unclear. The authors systematically analysed the bioethical and professionalism content of one season each of Grey's Anatomy and House M.D., two of the most popular current television medical dramas. The results indicate that these programmes are rife with powerful portrayals of bioethical issues and egregious deviations from the norms of professionalism and contain exemplary depictions of professionalism to a much lesser degree.

Aim: Streamlining consent for low-risk comparative effectiveness research (CER) could facilitate research, while safeguarding patients' rights. Materials & methods: 2618 adults were randomized to one of seven consent approaches (six streamlined and one traditional) for a hypothetical, low-risk CER study. A survey measured understanding, voluntariness, and feelings of respect. Results: Participants in all arms had a high understanding of the trial and positive attitudes toward the consent interaction. Highest satisfaction was with a streamlined approach showing a video before the medical (...) appointment. Participants in streamlined were more likely to mistakenly think a signature was required. Conclusion: Streamlined consent was no less acceptable than traditional, signed consent. Streamlined and traditional approaches achieved similar levels of understanding, voluntariness and a feeling that the doctor–patient interaction was respectful. (shrink)

As interest in comparative effectiveness research grows, questions have emerged regarding whether it is ever acceptable to alter informed consent requirements for research when patients are randomly assigned to widely-used therapies. This paper reports on interviews with Institutional Review Board members and researchers and on focus groups with patients from Geisinger and Johns Hopkins health systems. The objective was to elicit participants' views of the acceptability of four different disclosure and authorization models for low-risk pragmatic comparative effectiveness trials of widely-used (...) therapies. Results suggest that although participants valued autonomous choice, many also believed that it was acceptable to streamline information disclosure and to use an opt-out process for eligible individuals who would prefer not to participate. This provides some preliminary evidence that relevant stakeholders find alternatives to traditional informed consent acceptable for low-risk pragmatic comparative effectiveness trials of widely-used therapies as long as a sufficient amount of choice is preserved. (shrink)

Although the concept of dignity is commonly invoked in clinical care, there is not widespread agreement—in either the academic literature or in everyday clinical conversations—about what dignity means. Without a framework for understanding dignity, it is difficult to determine what threatens patients’ dignity and, conversely, how to honor commitments to protect and promote it. This article aims to change that by offering the first conceptual model of dignity for patients in the intensive care unit. The conceptual model we present is (...) based on the notion that there are three sources of patients’ dignity—their shared humanity, personal narratives, and autonomy—each of which independently warrants respect. The article describes each source of dignity and draws on examples to illustrate how clinician attitudes, actions, and behaviors can either contribute to, or detract from, expressions of respect for patient dignity. (shrink)

We report the results of a randomized trial to assess the impact of an innovative ethics curriculum on the knowledge and confidence of 85 medical house officers in a university hospital programme, as well as their responses to a simulated clinical case. Twenty-five per cent of the house officers received a lecture series, 25 per cent received lectures and case conferences, with an ethicist in attendance, and 50 per cent served as controls. A post-intervention questionnaire was administered. Knowledge scores did (...) not differ among the groups. Confidence regarding ethical issues was significantly greater in the aggregate intervention group compared to the control group. Confidence regarding procedural issues related to ethics was significantly higher for the EI group than for the controls. Responses to a simulated case showed that significantly fewer house officers in the EI group would intubate a patient for whom such therapy would be futile. We conclude that ethics education can have an impact on house officers' confidence and their responses to a simulated case, and that the EI was more effective than the LI. Such results have implications regarding the implementation of ethics education during residency. (shrink)

As concerns about the negative health effects of unhealthy eating, overweight and obesity have increased, so too have policy efforts to promote healthy eating. Federal, state, and local governments have proposed and implemented a variety of healthy eating policies. Many of these policies are controversial, facing objections that range from the practical (e.g., the policy won’t succeed at improving people’s diets) to the ethical (e.g., the policy is paternalistic or inequitable). Especially controversial have been policies limiting the options offered in (...) the marketplace, limiting access to certain options, or providing disincentives for the purchase of certain options. Examples of such policies include proposed .. (shrink)

In the past ten years, there has been growing interest in and concern about protecting the privacy of personal medical information. Insofar as medical records increasingly are stored electronically, and electronic information can be shared easily and widely, there have been legislative efforts as well as scholarly analyses calling for greater privacy protections to ensure that patients can feel safe disclosing personal information to their health-care providers. At the same time, the volume of biomedical research conducted in this country continues (...) to grow. The budget of the National Institutes of Health, for example, was $20,298 million in 2001, having more than doubled from a budget of $9,218 million 10 years before. This growing body of research includes increased efforts to use stored medical records as a source of data for health services, epidemiologic, and clinical studies. (shrink)

In the past ten years, there has been growing interest in and concern about protecting the privacy of personal medical information. Insofar as medical records increasingly are stored electronically, and electronic information can be shared easily and widely, there have been legislative efforts as well as scholarly analyses calling for greater privacy protections to ensure that patients can feel safe disclosing personal information to their health-care providers. At the same time, the volume of biomedical research conducted in this country continues (...) to grow. The budget of the National Institutes of Health, for example, was $20,298 million in 2001, having more than doubled from a budget of $9,218 million 10 years before. This growing body of research includes increased efforts to use stored medical records as a source of data for health services, epidemiologic, and clinical studies. (shrink)

Common hospital and surgical center responses to the Covid‐19 pandemic included curtailing “elective” procedures, which are typically determined based on implications for physical health and survival. However, in the focus solely on physical health and survival, procedures whose main benefits advance components of well‐being beyond health, including self‐determination, personal security, economic stability, equal respect, and creation of meaningful social relationships, have been disproportionately deprioritized. We describe how female reproduction‐related procedures, including abortion, surgical sterilization, reversible contraception devices and in vitro fertilization, (...) have been broadly categorized as “elective,” a designation that fails to capture the value of these procedures or their impact on women's overall well‐being. We argue that corresponding restrictions and delays of these procedures are problematically reflective of underlying structural views that marginalize women's rights and interests and therefore threaten to propagate gender injustice during the pandemic and beyond. Finally, we propose a framework for triaging reproduction‐related procedures during Covid‐19 that is more individualized, accounts for their significance for comprehensive well‐being, and can be used to inform resumption of operations as well as subsequent restriction phases. (shrink)

U.S. researchers and scholars often point to two legal factors as significant obstacles to the inclusion of pregnant women in clinical research: the Department of Health and Human Services’ regulatory limitations specific to pregnant women's research participation and the fear of liability for potential harm to children born following a pregnant woman's research participation. This article offers a more nuanced view of the potential legal complexities that can impede research with pregnant women than has previously been reflected in the literature. (...) It reveals new insights into the role of legal professionals throughout the research pathway, from product conception to market, and it highlights a variety of legal factors influencing decision-making that may slow or halt research involving pregnant women. Our conclusion is that closing the evidence gap created by the underrepresentation and exclusion of pregnant women in research will require targeted attention to the role of legal professionals and the legal factors that influence their decisions. (shrink)

Current strategies to address global inequities in access to life-saving vaccines use averaged national income data to determine eligibility. While largely successful in the lowest income countries, we argue that this approach could lead to significant inefficiencies from the standpoint of justice if applied to middle-income countries, where income inequalities are large and lead to national averages that obscure truly needy populations. Instead, we suggest alternative indicators more sensitive to social justice concerns that merit consideration by policy-makers developing new initiatives (...) to redress health inequities in middle-income countries. (shrink)

The use of aggregated quality of life estimatesin the formation of public policy and practiceguidelines raises concerns about the moralrelevance of variability in values inpreferences for health care. This variabilitymay reflect unique and deeply held beliefs thatmay be lost when averaged with the preferencesof other individuals. Feminist moral theorieswhich argue for attention to context andparticularity underline the importance ofascertaining the extent to which differences inpreferences for health states revealinformation which is morally relevant toclinicians and policymakers. To facilitatethese considerations, we present (...) an empiricalstudy of preferences for the timing andoccurrence of health states associated withhormone replacement therapy (HRT). Sixteenwomen between the ages of 45 and 55 wereenrolled in this pilot study. Theirpreferences regarding five health statesassociated with HRT (menopausal symptoms, sideeffects of HRT, breast cancer, myocardialinfarction, and osteoporosis) were assessed inquantitative terms known as utilities. Twostandard methods, the visual analog scale (VAS) and the standard gamble (SG), were used toassess utility and time preference (calculatedas a discount rate). The wide variability ofresponses underlines the importance oftailoring health care to individual women'spreferences. Policy guidelines whichincorporate utility analysis must recognize thenormative limitations of aggregatedpreferences, and the moral relevance ofindividual conceptions of health. (shrink)