Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)
This paper challenges the leading common morality accounts of medical ethics which hold that medical ethics is nothing but the ethics of everyday life applied to today’s high-tech medicine. Using illustrative examples, the paper shows that neither the Beauchamp and Childress four-principle account of medical ethics nor the Gert et al 10-rule version is an adequate and appropriate guide for physicians’ actions. By demonstrating that medical ethics is distinctly different from the ethics of everyday life and cannot be derived from (...) it, the paper argues that medical professionals need a touchstone other than common morality for guiding their professional decisions. That conclusion implies that a new theory of medical ethics is needed to replace common morality as the standard for understanding how medical professionals should behave and what medical professionalism entails. En route to making this argument, the paper addresses fundamental issues that require clarification: what is a profession? how is a profession different from a role? how is medical ethics related to medical professionalism? The paper concludes with a preliminary sketch for a theory of medical ethics. (shrink)
Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim (...) of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)
This paper challenges the long-standing and widely accepted view that medical ethics is nothing more than common morality applied to clinical matters. It argues against Tom Beauchamp and James Childress’s four principles; Bernard Gert, K. Danner Clouser and Charles Culver’s ten rules; and Albert Jonsen, Mark Siegler, and William Winslade’s four topics approaches to medical ethics. First, a negative argument shows that common morality does not provide an account of medical ethics and then a positive argument demonstrates why the medical (...) profession requires its own distinctive ethics. The paper also provides a way to distinguish roles and professions and an account of the distinctive duties of medical ethics. It concludes by emphasizing ways in which the uncommon morality approach to medical ethics is markedly different from the common morality approach. (shrink)
Currently, some of the most significant moral issues involving genetic links relate to genetic knowledge. In this paper, instead of looking at the frequently addressed issues of responsibilities professionals or institutions have to individuals, I take up the question of what responsibilities individuals have to one another with respect to genetic knowledge. I address the questions of whether individuals have a moral right to pursue their own goals without contributing to society's knowledge of population genetics, without adding to their family's (...) knowledge of its genetic history, and without discovering genetic information about themselves and their offspring. These questions lead to an examination of the presumed right to genetic ignorance and an exploration of a variety of social bonds. Analyzing cases in light of these considerations leads to a surprising conclusion about a widely accepted precept of genetic counseling, to some ethical insights into typical problems, and to some further unanswered questions about personal responsibility in the face of genetic knowledge. (shrink)
Human microbiome research has revealed that legions of bacteria, viruses, and fungi live on our skin and within the cavities of our bodies. New knowledge from these recent studies shows that humans are superorganisms and that the microbiome is indispensible to our lives and our health. This volume explores some of the science on the human microbiome and considers the ethical, legal, and social concerns that are raised by this research.
Policies for the allocation of COVID-19 vaccine were implemented in early 2021 as soon as vaccine became available. Those responsible for the planning and execution of COVID-19 vaccination had to make choices about who received vaccination first while numerous authors offered their own recommendations. This paper provides an account of how such decisions should be made by focusing on the specifics of the situation at hand. In that light, I offer an argument for prioritising those who are likely vectors of (...) the disease and a criticism of the victim-focused priority proposals put forward by the US Centers for Disease Control and Prevention, the National Academies of Sciences, Engineering, and Medicine, the UK National Health Service, and others. I also offer thoughts on how those authors may have gone astray. (shrink)
The human microbiome is the bacteria, viruses, and fungi that cover our skin, line our intestines, and flourish in our body cavities. Work on the human microbiome is new, but it is quickly becoming a leading area of biomedical research. What scientists are learning about humans and our microbiomes could change medical practice by introducing new treatment modalities. This new knowledge redefines us as superorganisms comprised of the human body and the collection of microbes that inhabit it and reveals how (...) much we are a part of our environment. The understanding that microbes are not only beneficial but sometimes necessary for survival recasts our interaction with microbes from adversarial to neighborly. This volume explores some of the science that makes human microbiome research possible. It then considers ethical, legal, and social concerns raised by microbiome research. Chapters explore issues related to personal identity, property rights, and privacy. The authors reflect on how human microbiome research challenges reigning views on public health and research ethics. They also address the need for thoughtful policies and procedures to guide the use of the biobanked human samples required for advancing this new domain of research. In the course of these explorations, they introduce examples from the history of biomedical science and recent legal cases that shed light on the issues and inform the policy recommendations they offer at the end of each topic's discussion.This volume is the product of an NIH Human Microbiome Project grant. It represents three years of conversations focused on consensus formation by the twenty-seven members of the interdisciplinary Microbiome Working Group. (shrink)
In this article the authors reflect on regulations which have been developed to protect research subjects and data in research which uses human subjects. They suggest that regulations related to informed consent and privacy protection are burdensome in research which uses human subjects. They argue that a new category of research risk must be established which informs research subjects of the level of risk that they will be exposed to by participating in the research.
To inform the ongoing discussion of whether claims of conscientious objection allow medical professionals to refuse to perform tasks that would otherwise be their duty, this paper begins with a review of the philosophical literature that describes conscience as either a moral sense or the dictate of reason. Even though authors have starkly different views on what conscience is, advocates of both approaches agree that conscience should be obeyed and that keeping promises is a conscience-given moral imperative. The paper then (...) considers exemplars of conscientious objection—Henry David Thoreau, Mohandas Gandhi, and Martin Luther King Jr.—to identify the critical feature of conscientious objection as willingness to bear the burdens of one’s convictions. It concludes by showing that medical professionals who put their own interests before their patients’ welfare violate their previous commitments and misappropriate the title “conscientious objector” because they are unwilling to bear the burdens of their choices and instead impose burdens on their patients and colleagues. (shrink)
Standard views on surrogate decision making present alternative ideal models of what ideal surrogates should consider in rendering a decision. They do not, however, explain the physician''s responsibility to a patient who lacks decisional capacity or how a physician should regard surrogates and surrogate decisions. The authors argue that it is critical to recognize the moral difference between a patient''s decisions and a surrogate''s and the professional responsibilities implied by that distinction. In every case involving a patient who lacks decisional (...) capacity, physicians and the treatment team have to make judgments about the appropriateness of both the surrogate and the surrogate''s decision. They have to assess the surrogate''s decisional capacity and attitude toward the patient as well as the reasons that support the surrogate''s decision. This paper provides a model for acceptable surrogate decisions and a standard for blocking inappropriate surrogates. Only decisions based on widely shared reasons are allowable for surrogate refusal of highly beneficial treatment. (shrink)
The use of organs obtained from executed prisoners in China has recently been condemned by every major transplant organization. The government of the People's Republic of China has also recently made it illegal to provide transplant organs from executed prisoners to foreigners transplant tourists. Nevertheless, the extreme shortage of transplant organs in the U.S. continues to make organ transplantation in China an appealing option for some patients with end-stage disease. Their choice of traveling to China for an organ leaves U.S. (...) transplant programs with decisions about how to respond to the needs of patients who return after transplantation. By discussing two cases that raised this dilemma, we argue for upholding medicine's commitments to traditional principles of beneficence and nonjudgmental regard in sorting out the policies that a transplant program should adopt. We also explain how position statements that aim for the high ground of moral purity fail to give appropriate weight to the needs and suffering of present and future patients in the U.S. and in China. (shrink)
In this paper I argue for recognizing the moral duty to participate in research. I base my argument on the need for biomedical research and the fact that at some point studies require human participants, what I call collaborative necessity. In presenting my position, I argue against the widely accepted views of Han Jonas and all of those who have accepted his declarations without challenge. I go on to show why it is both just and fair to invite and encourage (...) people to participate in studies. It is just because research participation is the necessary means to achieve the broadly shared goals of preventing and curing disease and alleviating disease symptoms. Mutual love requires us to be willing to do for others what we would want them to do for us. It is fair because the approach treats similarly situated people in the same way. Research participation is morally required because failing to do one's part in the collaborative project of advancing biomedical science would be free-riding. People who exempt themselves from participation while eagerly accepting benefits from others doing their part are taking advantage of their compatriots and treating themselves as more deserving than others when they are not. (shrink)
Over the past 15 years, medical schools have paid some attention to the importance of developing students' communication skills as part of their medical education. Over the past decade, medical ethics has been added to the curriculum of most U.S. medical schools, at least on paper. More recently, there has been growing discussion of the importance of professionalism in medical education. Yet, the nature and content of these fields and their relationship to one another remains confused and vague, and that (...) lack of clarity, in turn, impairs the effectiveness of medical education. This ambiguity invites serious contention over who should design and teach the curriculum as well as when, where, and how it should be taught. (shrink)
Because the process of moving from moral principles and facts to action-guiding moral conclusions has not been articulated clearly enough to be useful in a practical way, we designed a systematic approach to aid learners and clinicians in their application of ethical principles to the resolution of clinical dilemmas. Our model for clinical moral reasoning is intended to provide a clear and replicable structure that makes the thought process involved in reasoning about clinical cases explicit. In this paper we present (...) the model and demonstrate how it can be used in three clinical cases. (shrink)
Medicine needs our trust. We need to be able to rely on individual clinicians and researchers, and we need to be able to have confidence in hospitals and clinics. Yet the organization of our healthcare institutions is not designed to promote that trust. In fact, the structure of our medical institutions seems to undermine our faith.
This paper offers a constructivist account of bioethics as an alternative to previous discussions that explained the ethics of medicine by an extrapolation of principles or virtues from ordinary morality. Taking medicine as a higher and special calling, I argue that the practice of medicine would be impossible without the trust of patients. Because trust is a necessary condition for medical practice, the ethics of the profession must provide the principles for guiding physician behavior and the profession toward promoting trust (...) and being trustworthy. In a phrase, that principle is “seek trust and deserve it.” I sketch out how the concept of trust provides a different justification for common sense principles of bioethics and explain how the concept of trust provides reasonable guidance for resolving moral conflicts within medicine. The trust-seeking approach provides a new and unexpected ordering of some traditional medical values, it reveals the weightiness of previously undervalued bioethical precepts, and illuminates the centrality of some largely ignored obligations of medicine. It also has the power to guide clinical practice and to inform the profession about standards for medical institutions. (shrink)
Through a number of studies recently published in the psychology literature, T.D. Wilson, D.T. Gilbert, and others have demonstrated that our judgments about what our future mental states will be are contaminated by various distortions. Their studies distinguish a variety of different distortions, but they refer to them all with the generic term “affective forecasting.” The findings of their studies on normal volunteers are remarkably robust and, therefore, demonstrate that we are all vulnerable to the distortions of affective forecasting. a.
Traditional moral theories of rights and principles have dominated medical ethics discussions for decades. Appeals to utilitarian consequences, as well as the principles of respect for autonomy, beneficence, and justice, have provided the standard vocabulary and filled the literature of the field.Recently on the bioethics scene, however, there has been some discussion of virtue, and, particularly within the nursing ethics literature, appeals are being made to the feminist ethics of care. This intimation of a shift in the wind may have (...) to do with postmodern doubt, or it may be attributable to the claim that virtue theory and the ethics of care are more appropriate to private interaction; theories of rights and justice are best applied to the political domain of public policy. (shrink)
Because medicine can preserve and restore health and function, it is widely acknowledged as a basic good that a just society owes its members. Yet there is controversy over the scope of what should be provided, to whom, how, when and why. This comprehensive and authoritative book - by well-known philosophers, doctors, lawyers, political scientists, and economists - lays a theoretical foundation for understanding the debate, assesses how health care is distributed in different countries and to various social groups, and (...) analyzes practical issues in constructing a socially just health care system. (shrink)
I am grateful to the esteemed commentators for their critiques of my paper, ‘Why Not Common Morality’.1 As I read through their remarks, however, they seemed to be talking past my arguments. Their criticisms nevertheless make it clear that I need to explain myself better. I am therefore grateful to the editor for allowing me this opportunity to clarify my position. My paper presented two arguments for concluding that common morality is untenable as an account of medical ethics. First, I (...) provided a negative argument to show that common morality does not provide an adequate account of medical ethics. Second, I offered a positive argument that demonstrated why the medical professions require a distinct morality. My negative argument relies on counterexamples to show that the duties of medicine are different from the duties of everyday life. It is intended as a refutation of the claim by Tom Beauchamp and James Childress that ‘The common morality is applicable to all persons in all places, and we rightly judge all human conduct by its standards’.2 Logically, if any of the duties of medical ethics are inconsistent with common morality, they are not compatible with common morality standards. My counterexamples demonstrate that standards of conduct judged acceptable by common morality are irreconcilable with duties of medical ethics. Hence, they could not follow from the same principles. If the standards of common morality lead to particular judgments about the morality of a certain conduct, those same standards cannot also be the basis for reaching the opposite judgments about that sort of conduct. Charles Foster,3 Alex John London,4 Ruth Macklin5 and Bryanna Moore6 all suggest that exceptions to my examples refute my negative argument. As far as they go, …. (shrink)
a This paper is a revised and shortened version of my chapter, “Justice in Allocations for Terrorism, Biological Warfare, and Public Health” in Public Health Ethics, edited by Michael Boylan, Kluwer; 2004. Portions of this material were presented at the International Bioethics Retreat, Pavia, Italy, June 2003, and at the meetings of the Association for Politics and the Life Sciences, Philadelphia, September 2003.
This paper is a revised and shortened version of my chapter, “Justice in Allocations for Terrorism, Biological Warfare, and Public Health” in Public Health Ethics, edited by Michael Boylan, Kluwer; 2004. Portions of this material were presented at the International Bioethics Retreat, Pavia, Italy, June 2003, and at the meetings of the Association for Politics and the Life Sciences, Philadelphia, September 2003.
In their article, “The job of ‘ethics committees’”, Andrew Moore and Andrew Donnelly argue that current guidance documents provide that institutional research review committees ) perform two different and distinct functions, namely, a regulative review and an ethical review. They argue for separating those functions and for eliminating the ethics review role from IRBs. Instead, they want IRBs to focus exclusively on determining whether research proposals conform to governing regulations. In their argument, Moore and Donnelly correctly note that regulatory requirements (...) and ethical requirements can conflict. That point is correct, but hardly surprising. After all, regulations are general and the research proposals are specific, so an individual proposal may not conform to the general formulation of the rule and yet be consistent with ethics. Thus, a rule may generally be regarded as expressing a relevant moral consideration while providing a conclusion that does not appropriately reflect an ethical determination in the specific case. This inconsistency need not amount to what Moore and Donelly characterise as a ‘repellent’ or an ‘unconscionable’ review decision. Moore and Donnelly are also concerned that IRB decisions may differ from each other in their review of the same proposal. Again, they are correct in recognising that such inconsistent outcomes would be less likely if IRBs were to focus exclusively on whether proposals conformed to the regulations. That said, I reach the opposite conclusion. As I see it, IRBs present us with a good example of when the possibility of inconsistency is a relatively small consideration in comparison to the important values that are served by IRBs considering their protocol reviews in light of ethics and conforming to regulations. Allow me to explain. The authors and endorsers of research ethics …. (shrink)
People who discuss medical ethics or bioethics come to very different conclusions about the levels of agreement in the field and the implications of consensus among health care professionals. In this paper I argue that these disagreements turn on a confusion of two distinct senses of medical ethics. I differentiate (1) medical ethics as a subject in applied ethics from (2) medical ethics as the professional moral commitments of health care professions. I then use the distinction to explain its significant (...) implications for medical ethics education. Drawing on the recent work of John Rawls, I also show the centrality of philosophy in medical ethics by illustrating how contemporary philosophy can be used to construct an ethical framework for the medical professions. (shrink)
Those who read only the introductory section of “Physician Obligation in Disaster Preparedness and Response,” the statement from the AMA's Council on Ethical and Judicial Affairs, apparently an elaboration on CEJA Opinion 3-I-04, E-9.067, will find an expression of laudable professional responsibility in the face of a disaster. There the AMA authors explicitly acknowledge “that unique responsibilities beyond planning rest on the shoulders of the medical profession”. They also declare that, “physicians are needed to care for victims. In some instances, (...) this will require individual physicians to place their health or their lives at risk”. As the AMA authors note, these responsibilities have been accepted at least since the writing of Thomas Percival in 1803 and endorsed by the AMA in posting their 1847 code. The commitments are also asserted in the preamble of the AMA's most current Principles of Medical Ethics, which states that “a physician must recognize responsibility to patients, first and foremost,” and again in Principle VIII, which states that “[a] physician shall, when caring for a patient, regard responsibility to the patient as paramount”. (shrink)