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)

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.

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)

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

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.

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)

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)

Hastings Center Report, Volume 52, Issue 3, Page 29-31, May–June 2022.

: Arguments for efficiency in health care delivery have been used to support some level of withholding of information about available treatment options from patients in managed care systems. To the extent that such arguments prevail, they may necessitate changes in the established understanding of and commitment to informed consent and the disclosure of information to patients.

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)

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)

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)

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 ...

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)

: The focus of questions of justice in health policy has shifted during the last 20 years, beginning with questions about rights to health care, and then, by the late 1980s, turning to issues of rationing. More recently, attention has focused on alternatives to cost-effectiveness analysis. In addition, health inequalities, and not just inequalities in access to health care, have become the subject of moral analysis. This article examines how such trends have transformed the philosophical landscape and encouraged some in (...) bioethics to seek guidance on normative questions from outside of the contours of traditional philosophical arguments about justice. (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)

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...

: 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.

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)

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 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)

Book reviewed in this article: Ethical Issues in Social Research. Edited by Tom L. Beauchamp, Ruth R. Faden, R. Jay Wallace, Jr., and LeRoy Walters. Baltimore: The Johns Hopkins University Press, 1982. xii + 436 pp. $25.00 (hardcover); $8.95 (paper). Ethics of Human Subject Research. Edited by Allan J. Kimmel, Jr. San Francisco: Jossey‐Bass, 1981. 106 pp. $6.95 (paper). Social Research Ethics. Edited by Martin Bulmer. New York: Holmes & Meier, 1982. xiv + 284 pp. $39.50 (hardcover); $14.50 (...) (paper). The Ethics of Social Research: Field‐work, Regulation and Publication. Edited by Joan E. Sieber. New York: Springer‐Verlag, 1982. x + 187 pp. $23.50 (hardcover). The Ethics of Social Research: Surveys and Experiments. Edited by Joan E. Sieber. New York: Springer‐Verlag, 1982. xii + 249 pp. $23.50 (hardcover). (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)

Recent legislation, such as the Patient Self-Determination Act, establishes advance directives as an acceptable procedural means of incorporating patients’ preferences for life-sustaining treatments into their medical care. Advance directives can enhance medical decision making since they provide patients with an opportunity to communicate their preferences before suffering from an acute illness that may preclude their ability to do so.Although patients expect discussions about life-sustaining therapies to be initiated by their physicians, very little is known about what prompts physicians to discuss (...) advance directives with their patients. As in other areas of clinical decision making, there is evidence that patients’ sociodemographic factors influence whether discussions about advance directives occur between patients and their physicians. In one study of persons with the acquired immunodeficiency syndrome, those who had not had discussions about advance directives with their physicians tended to be non-white, have no prior hospitalization, and were more likely to have been cared for in a health maintenance organization than in a teaching hospital. (shrink)

Recent legislation, such as the Patient Self-Determination Act, establishes advance directives as an acceptable procedural means of incorporating patients’ preferences for life-sustaining treatments into their medical care. Advance directives can enhance medical decision making since they provide patients with an opportunity to communicate their preferences before suffering from an acute illness that may preclude their ability to do so.Although patients expect discussions about life-sustaining therapies to be initiated by their physicians, very little is known about what prompts physicians to discuss (...) advance directives with their patients. As in other areas of clinical decision making, there is evidence that patients’ sociodemographic factors influence whether discussions about advance directives occur between patients and their physicians. In one study of persons with the acquired immunodeficiency syndrome, those who had not had discussions about advance directives with their physicians tended to be non-white, have no prior hospitalization, and were more likely to have been cared for in a health maintenance organization than in a teaching hospital. (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)

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)